ClinicalTrials.gg
TerminatedNCT03337698Morpheus LungUpdated May 12, 2026Results posted

A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer)

A Phase 1/2 interventional study of Atezolizumab and Cobimetinib in Carcinoma, Non-Small-Cell Lung, sponsored by Hoffmann-La Roche. Terminated at 29 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-12.

Sponsored by Hoffmann-La Roche · Phase 1/2, Interventional, and Treatment

Why this study was terminated
Study was closed early as the sponsor decided not to continue development of certain treatment combinations.
Phase
Phase 1/2
Study type
Interventional
Enrollment
314
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study will evaluate the efficacy, safety, and pharmacokinetics of immunotherapy-based treatment combinations in participants with metastatic non-small cell lung cancer (NSCLC).

Two cohorts will be enrolled in parallel in this study: Cohort 1 will consist of participants with tumor PD-L1 expression who have received no prior systemic therapy for metastatic NSCLC, and Cohort 2 will consist of participants who experienced disease progression during or following treatment with a platinum-containing regimen and a PD-L1/PD-1 checkpoint inhibitor, given in combination as one line of therapy or as two separate lines of therapy, regardless of PD-L1 expression. In each cohort, eligible participants will initially be assigned to one of several treatment arms (Stage 1). Participants who experience disease progression, loss of clinical benefit, or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment regimen (Stage 2).

02

Conditions studied

  • Carcinoma, Non-Small-Cell Lung
03

In context

Carcinoma, Non-Small-Cell Lung

7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.

This study's enrollment of 314 is above the median of 62 across 6,019 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,101 studies on the registry; 87 are open to participants now.

Of its 330 completed or terminated interventional studies of FDA-regulated products, 248 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

General Inclusion Criteria

  • (ECOG) performance Status of 0 or 1
  • greater than or equal to 3 months
  • or cytologically confirmed , non-squamous or squamous Non-Small Cell Lung Cancer (NSCLC)
  • (at least one target lesion)
  • Adequate hematologic and end-organ function
  • Tumor accessible for
  • For women of : agreement to remain abstinent (refrain from heterosexual intercourse) or use measures and agreement to refrain from donating eggs as outlined for each specific treatment arm
  • For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as outlined for each specific treatment arm

Inclusion Criteria for Cohort 1

  • No prior systemic therapy for metastatic NSCLC
  • High tumor expression, defined as Tumor Proportion Score (TPS) or TCs >= 50% or TC3

Inclusion Criteria for Cohort 2

- Disease progression during or following treatment for metastatic or locally advanced, inoperable NSCLC

Exclusion Criteria

  • Prior allogeneic stem cell or solid organ transplantation
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
  • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
  • History of
  • Active or history of disease or immune deficiency
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan
  • History of other than NSCLC within 2 years prior to screening
  • Active tuberculosis
  • Severe infection within 4 weeks prior to initiation of study treatment
Terms in these criteria, in plain language(12)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

Leptomeningeal disease

Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.

Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
314 participants (actual)

Study arms

  • Active comparator
    Stage 1: Cohort 1: Atezolizumab

    Participants in the Atezolizumab arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit. Participants who progressed on treatment, may have the option of receiving Atezolizumab + Pemetrexed + Carboplatin or Atezolizumab + Gemcitabine + Carboplatin treatment, provided they meet the eligibility criteria.

    Drug: Atezolizumab

  • Experimental
    Stage 1: Cohort 1: Atezolizumab + Cobimetinib

    Participants in the Atezolizumab + Cobimetinib arm will receive treatment (cycle length 28 days) until unacceptable toxicity or loss of clinical benefit. Participants who progressed on 1L treatment, may have the option of receiving Atezolizumab + Pemetrexed + Carboplatin or Atezolizumab + Gemcitabine + Carboplatin treatment, provided they meet the eligibility criteria. Participants who progressed on 2L/3L treatment, may have the option of receiving Atezolizumab + RO6958688, Atezolizumab + Docetaxel or Atezolizumab + Linagliptin treatment, provided they meet the eligibility criteria.

    Drug: Atezolizumab · Drug: Cobimetinib

  • Experimental
    Stage 1: Cohort 1: Atezolizumab + RO6958688

    Participants in the Atezolizumab + RO6958688 arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit. Participants who progressed on 1L treatment, may have the option of receiving Atezolizumab + Pemetrexed + Carboplatin or Atezolizumab + Gemcitabine + Carboplatin treatment, provided they meet the eligibility criteria. Participants who progressed on 2L/3L treatment, may have the option of receiving Atezolizumab + Docetaxel treatment or Atezolizumab + Linagliptin treatment, provided they meet the eligibility criteria.

    Drug: Atezolizumab · Drug: RO6958688 · Drug: Tocilizumab

  • Active comparator
    Stage 1: Cohort 2: Docetaxel

    Participants in the Docetaxel arm will receive treatment (cycle length 21 days) until unacceptable toxicity or disease progression. Participants who progressed on treatment may have the option of receiving Atezolizumab + RO6958688 or Atezolizumab + Linagliptin treatment, provided they meet the eligibility criteria.

    Drug: Docetaxel

  • Experimental
    Stage 1: Cohort 2: Atezolizumab + Cobimetinib

    Participants in the Atezolizumab + Cobimetinib arm will receive treatment (cycle length 28 days) until unacceptable toxicity or loss of clinical benefit. Participants who progressed on treatment, may have the option of receiving Atezolizumab + Pemetrexed + Carboplatin, Atezolizumab + Gemcitabine + Carboplatin, Atezolizumab + RO6958688, Atezolizumab + Docetaxel or Atezolizumab + Linagliptin treatment, provided they meet the eligibility criteria.

    Drug: Atezolizumab · Drug: Cobimetinib

  • Experimental
    Stage 1: Cohort 2: Atezolizumab + CPI-444

    Participants in the Atezolizumab + CPI-444 arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit. Participants who progressed on treatment, may have the option of receiving Atezolizumab + RO6958688, Atezolizumab + Docetaxel or Atezolizumab + Linagliptin treatment, provided they meet the eligibility criteria.

    Drug: Atezolizumab · Drug: CPI-444

  • Experimental
    Stage 1: Cohort 2: Atezolizumab + RO6958688

    Participants in the Atezolizumab + RO6958688 arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit. Participants who progressed on treatment, may have the option of receiving Atezolizumab + Pemetrexed + Carboplatin, Atezolizumab + Gemcitabine + Carboplatin, Atezolizumab + Docetaxel or Atezolizumab + Linagliptin treatment, provided they meet the eligibility criteria.

    Drug: Atezolizumab · Drug: RO6958688 · Drug: Tocilizumab

  • Experimental
    Stage 1: Cohort 2: Atezolizumab + Ipatasertib

    Participants in the Atezolizumab + Ipatasertib arm will receive treatment (cycle length 28 days) until unacceptable toxicity or loss of clinical benefit. Participants who progressed on treatment, may have the option of receiving Atezolizumab + Docetaxel treatment or Atezolizumab + Linagliptin treatment, provided they meet the eligibility criteria.

    Drug: Atezolizumab · Drug: Ipatasertib

  • Experimental
    Stage 1: Cohort 2: Atezolizumab + Docetaxel

    Participants in Atezolizumab + Docetaxel arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit. Participants who progressed on treatment, may have the option of receiving Atezolizumab + Linagliptin treatment, provided they meet the eligibility criteria.

    Drug: Atezolizumab · Drug: Docetaxel

  • Experimental
    Stage 1: Cohort 2: Atezolizumab + Bevacizumab

    Participants in Atezolizumab + Bevacizumab arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit. Participants who progressed on treatment, may have the option of receiving Atezolizumab + Docetaxel or Atezolizumab + Linagliptin treatment, provided they meet the eligibility criteria.

    Drug: Atezolizumab · Drug: Bevacizumab

  • Experimental
    Stage 2: Cohort 1: Atezolizumab + Pemetrexed + Carboplatin

    Participants in the Atezolizumab + Pemetrexed + Carboplatin arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

    Drug: Atezolizumab · Drug: Pemetrexed · Drug: Carboplatin

  • Experimental
    Stage 2: Cohort 1: Atezolizumab + Gemcitabine + Carboplatin

    Participants in the Atezolizumab + Gemcitabine + Carboplatin arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

    Drug: Atezolizumab · Drug: Carboplatin · Drug: Gemcitabine

  • Experimental
    Stage 2: Cohort 2: Atezolizumab + RO6958688

    Participants in the Atezolizumab + RO6958688 arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

    Drug: Atezolizumab · Drug: RO6958688 · Drug: Tocilizumab

  • Experimental
    Stage 2: Cohort 2: Atezolizumab + Docetaxel

    Participants in the Atezolizumab + Docetaxel arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit. Participants who have received treatment with Atezolizumab + Docetaxel in Stage 1 will not receive this treatment in Stage 2.

    Drug: Atezolizumab · Drug: Docetaxel

  • Experimental
    Stage 2: Cohort 2: Atezolizumab + Linagliptin

    Participants in the Atezolizumab + Linagliptin arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

    Drug: Atezolizumab · Drug: Linagliptin

  • Experimental
    Stage 1: Cohort 2: Atezolizumab + Sacituzumab Govitecan

    Participants in the Atezolizumab + Sacituzumab Govitecan arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

    Drug: Atezolizumab · Drug: Sacituzumab Govitecan

  • Experimental
    Stage 1: Cohort 2: Atezolizumab + Bevacizumab + Radiotherapy

    Participants in the Atezolizumab + Bevacizumab + Radioatherapy arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

    Drug: Atezolizumab · Drug: Bevacizumab · Other: Radiation

  • Experimental
    Stage 1: Cohort 2: Atezolizumab + Evolocumab

    Participants in the Atezolizumab + Evolocumab arm will receive treatment (cycle length 28 days) until unacceptable toxicity or loss of clinical benefit.

    Drug: Atezolizumab · Drug: Evolocumab

  • Active comparator
    Stage 1: Cohort 1: Atezolizumab + Tiragolumab

    Participants in the Atezolizumab + Tiragolumab arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

    Drug: Atezolizumab · Drug: Tiragolumab

  • Experimental
    Stage 1: Cohort 1: Atezolizumab + Tiragolumab + XL092 (Zanzalintinib)

    Participants in the Atezolizumab + Tiragolumab + XL092 arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

    Drug: Atezolizumab · Drug: Tiragolumab · Drug: XL092

  • Experimental
    Stage 1: Cohort 2: Atezolizumab + Camonsertib

    Participants in the Atezolizumab + Camonsertib arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

    Drug: Atezolizumab · Drug: Camonsertib

  • Experimental
    Stage 1: Cohort 2: Atezolizumab + Bevacizumab + Camonsertib

    Participants in the Atezolizumab + Bevacizumab + Comonsertib arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

    Drug: Atezolizumab · Drug: Bevacizumab · Drug: Camonsertib

  • Experimental
    Stage 1: Cohort 2: Atezolizumab + Bevacizumab + Tiragolumab

    Participants in the Atezolizumab + Bevacizumab + Tiragolumab arm will receive treatment (cycle length 21 days) until unacceptable toxicity or loss of clinical benefit.

    Drug: Atezolizumab · Drug: Bevacizumab · Drug: Tiragolumab

Interventions

  • Atezolizumab is administered by IV on Day 1 of each 21 day cycle or on Days 1 and 15 of each 28 day cycle.

  • Cobimetinib is administered orally on Days 1-21 of a 28 day cycle.

  • Cycle 1: RO6958688 is administered by IV infusion on Days 1, 8, and 15 of a 21 day cycle at increasing dosage. Subsequent cycles: RO6958688 is administered by IV infusion on Days 1, 8, and 15 of a 21 day cycle.

  • Docetaxel is administered by IV on Day 1 of each 21 day cycle.

  • CPI-444 is administered orally twice daily on Days 1- 21, of a 21 day cycle.

  • Pemetrexed is administered by IV on Day 1 of a 21 day cycle.

  • Carboplatin is administered by IV on day 1 of the first 4 or 6 cycles out of a 21 day cycle.

  • Gemcitabine is administered by IV on Days 1 and 8 of the first 4 or 6 cycles out of a 21 day cycle.

  • Linagliptin is administered orally once daily on Days 1 to 21 out of a 21 day cycle.

  • Tocilizumab is administered for the management of cytokine-release syndrome in the RO6958688-containing arms.

  • Ipatasertib will be administered orally once a day on Days 1-21 of each 28-day cycle.

  • Bevacizumab is administered by IV on Day 1 of each 21-day cycle.

  • Sacituzumab Govitecan is administered by IV on Day 1 and 8 of each 21-day cycle.

  • OtherRadiation

    Radiotherapy up to 21 days

  • Evolocumab is administered subcutaneously at a dose of 140 mg on Days 1 and 15 of each 28-day cycle.

  • Tiragolumab is administered on Day 1 of each 21 day cycle.

  • DrugXL092

    XL092 is administered orally once a day on Day 1 to Day 21 of a 21 day cycle.

    Also known as: Zanzalintinib

  • Camonsertib is administered orally on Days 1-3, Days 8-10 of a 21 day cycle.

06

What researchers measure

Primary outcomes

  1. Stage 1: Percentage of Participants With Objective Response (OR) as Determined by Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1)

    OR was defined as a complete response (CR) or partial response (PR) on two consecutive occasions, ≥4 weeks apart, during Stage 1 as determined by the investigator using RECIST v.1.1. Objective response rate (ORR) was defined as the percentage of participants with OR. CR was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) have a reduction in short axis to \<10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of all target lesions, taking as reference the baseline SOD, in the absence of CR. 95% confidence intervals (CI) for rates were constructed using Clopper-Pearson method. Percentages have been rounded off. The participant in the 'Stage 1 Cohort 2 (S1C2): Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the efficacy analyses.

    Time frame: Up to 50.4 months

Secondary outcomes

  1. Stage 1: Progression-free Survival (PFS) as Determined by Investigator According to RECIST V1.1

    PFS was defined as the time from study treatment initiation to the first occurrence of documented PD, as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum in the study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm or unequivocal progression of existing non-target lesions. Participants who did not have documented PD or death, PFS was censored at the day of the last tumor assessment. Kaplan-Meier (K-M) method was used to estimate PFS. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the efficacy analyses.

    Time frame: From randomization to the first occurrence of PD or death (Up to 48.6 months)

  2. Stage 1: PFS Rate at Month 6

    PFS was defined as the time from study treatment initiation to the first occurrence of documented PD, as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum in the study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm or unequivocal progression of existing non-target lesions. Participants who did not have documented PD or death, PFS was censored at the day of the last tumor assessment. The KM approach was used to estimate the percentage of participants who were event-free for PFS at Month 6. Percentages have been rounded off. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the efficacy analyses.

    Time frame: At Month 6

  3. Stage 1: Overall Survival (OS)

    OS was defined as the time from randomization to death from any cause. Participants who were still alive at the time of OS analysis were censored at the last date they were known to be alive. K-M method was used to estimate OS. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the efficacy analyses.

    Time frame: From randomization to death (Up to 67 months)

  4. Stage 1: OS Rate at Month 6

    OS was defined as the time from randomization to death from any cause. Participants who were still alive at the time of OS analysis were censored at the last date they were known to be alive. The Kaplan-Meier approach was used to estimate the percentage of participants who were event-free for OS at Month 6. Percentages have been rounded off. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the efficacy analyses.

    Time frame: At Month 6

  5. Stage 1: Duration of Response (DOR), as Determined by Investigator According to RECIST V1.1

    DOR was defined as the time from the first occurrence of a documented OR until the time of documented PD or death from any cause, whichever occurred first as per investigator assessment using RECIST v1.1. DOR was calculated for participants who had a best confirmed OR of CR/PR. CR and PR were defined as outlined in the description for ORR outcome measure. PD=at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm or unequivocal progression of existing non-target lesions. Participants who did not have documented PD or death, DOR was censored at the day of the last tumor assessment. K-M method was used to estimate DOR. The participant in the 'S1C2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the efficacy analyses.

    Time frame: From first occurrence of a documented OR until the time of documented PD or death (Up to 50.4 months)

  6. Stage 1: Percentage of Participants With Disease Control (DC), as Determined by Investigator According to RECIST V1.1

    DC was defined as stable disease (SD) for ≥ 12 weeks or a CR or PR, as determined by the investigator according to RECIST v1.1 Disease control rate (DCR) was defined as the percentage of participants with DC. CR was defined as the disappearance of all target \& non-target lesions. Any pathological lymph nodes (whether target or non-target) have a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD=at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm or unequivocal progression of existing non-target lesions. Percentages have been rounded off.

    Time frame: Up to 50.4 months

  7. Stages 1 and 2: Number of Participants With Adverse Events (AEs)

    An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptoms, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. SAEs = Serious AEs; AESIs = Adverse Events of Special Interest.

    Time frame: From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months)

07

Results

Posted May 12, 2026

Participant flow

A total of 314 participants with metastatic non-small cell lung cancer (NSCLC) took part in the study from 27 Dec 2017 to 25 Nov 2025. The study had 2 cohorts: Cohort 1: participants with no prior systemic therapy for metastatic NSCLC \& Cohort 2: participants with 1 prior line of systemic therapy for NSCLC. Multiple combination therapies were compared against common control(s) in Cohorts 1 and 2.

Stage 1
Participant flow — Stage 1
MilestoneStage 1 Cohort 1: Control (Atezolizumab)Stage 1 Cohort 1: Atezolizumab + CobimetinibStage 1 Cohort 1: Atezolizumab + Cibisatamab (CEA-TCB)Stage 1 Cohort 1: Atezolizumab + TiragolumabStage 1 Cohort 2: Control (Docetaxel)Stage 1 Cohort 2: Atezolizumab + CobimetinibStage 1 Cohort 2: Atezolizumab + CEA-TCBStage 1 Cohort 2: Atezolizumab + CPI-444Stage 1 Cohort 2: Docetaxel + AtezolizumabStage 1 Cohort 2: Atezolizumab + IpatasertibStage 1 Cohort 2: Idasanutlin + DocetaxelStage 1 Cohort 2: Atezolizumab + BevacizumabStage 1 Cohort 2: Atezolizumab + Bevacizumab + RadiotherapyStage 1 Cohort 2: Atezolizumab + Sacituzumab Govitecan (SG)Stage 1 Cohort 2: Atezolizumab + EvolocumabStage 1 Cohort 2: Atezolizumab + CamonsertibStage 2 Cohort 1: Carboplatin + Pemetrexed + AtezolizumabStage 2 Cohort 2: Docetaxel + AtezolizumabStage 2 Cohort 2: Atezolizumab + Linagliptin
Started3511661511618311414530328000
Safety-evaluable population3511611511516300404330318000
Completed1511521011213290373428317000
Not completed200014504521411211000
Withdrew: Death2000420320034101000
Withdrew: Withdrawal by subject00001020031101010000
Withdrew: Progressive disease0000010100000000000
Withdrew: Protocol violation0000000001000000000
Withdrew: Physician decision0000000000001000000
Withdrew: Study terminated by sponsor0000000000015100000
Stage 2
Participant flow — Stage 2
MilestoneStage 1 Cohort 1: Control (Atezolizumab)Stage 1 Cohort 1: Atezolizumab + CobimetinibStage 1 Cohort 1: Atezolizumab + Cibisatamab (CEA-TCB)Stage 1 Cohort 1: Atezolizumab + TiragolumabStage 1 Cohort 2: Control (Docetaxel)Stage 1 Cohort 2: Atezolizumab + CobimetinibStage 1 Cohort 2: Atezolizumab + CEA-TCBStage 1 Cohort 2: Atezolizumab + CPI-444Stage 1 Cohort 2: Docetaxel + AtezolizumabStage 1 Cohort 2: Atezolizumab + IpatasertibStage 1 Cohort 2: Idasanutlin + DocetaxelStage 1 Cohort 2: Atezolizumab + BevacizumabStage 1 Cohort 2: Atezolizumab + Bevacizumab + RadiotherapyStage 1 Cohort 2: Atezolizumab + Sacituzumab Govitecan (SG)Stage 1 Cohort 2: Atezolizumab + EvolocumabStage 1 Cohort 2: Atezolizumab + CamonsertibStage 2 Cohort 1: Carboplatin + Pemetrexed + AtezolizumabStage 2 Cohort 2: Docetaxel + AtezolizumabStage 2 Cohort 2: Atezolizumab + Linagliptin
Started000000000000000023322
Safety-evaluable population000000000000000023220
Completed000000000000000022819
Not completed0000000000000000053
Withdrew: Study terminated by sponsor0000000000000000001
Withdrew: Death0000000000000000052
Long-term Survival Follow-up
Participant flow — Long-term Survival Follow-up
MilestoneStage 1 Cohort 1: Control (Atezolizumab)Stage 1 Cohort 1: Atezolizumab + CobimetinibStage 1 Cohort 1: Atezolizumab + Cibisatamab (CEA-TCB)Stage 1 Cohort 1: Atezolizumab + TiragolumabStage 1 Cohort 2: Control (Docetaxel)Stage 1 Cohort 2: Atezolizumab + CobimetinibStage 1 Cohort 2: Atezolizumab + CEA-TCBStage 1 Cohort 2: Atezolizumab + CPI-444Stage 1 Cohort 2: Docetaxel + AtezolizumabStage 1 Cohort 2: Atezolizumab + IpatasertibStage 1 Cohort 2: Idasanutlin + DocetaxelStage 1 Cohort 2: Atezolizumab + BevacizumabStage 1 Cohort 2: Atezolizumab + Bevacizumab + RadiotherapyStage 1 Cohort 2: Atezolizumab + Sacituzumab Govitecan (SG)Stage 1 Cohort 2: Atezolizumab + EvolocumabStage 1 Cohort 2: Atezolizumab + CamonsertibStage 2 Cohort 1: Carboplatin + Pemetrexed + AtezolizumabStage 2 Cohort 2: Docetaxel + AtezolizumabStage 2 Cohort 2: Atezolizumab + Linagliptin
Started1401369191120026282030522819
Completed0000000000000000000
Not completed1401369191120026282030522819
Withdrew: Arm terminated by sponsor0000000123000000000
Withdrew: Reason not specified0000000000002000101
Withdrew: Study terminated by sponsor0000100000045003020
Withdrew: Withdrawal by subject0100620213022140100
Withdrew: Lost to follow-up0000000000012110021
Withdrew: Death130129716814019171825202417

Outcome measures

PrimaryStage 1: Percentage of Participants With Objective Response (OR) as Determined by Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1)

OR was defined as a complete response (CR) or partial response (PR) on two consecutive occasions, ≥4 weeks apart, during Stage 1 as determined by the investigator using RECIST v.1.1. Objective response rate (ORR) was defined as the percentage of participants with OR. CR was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) have a reduction in short axis to \<10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of all target lesions, taking as reference the baseline SOD, in the absence of CR. 95% confidence intervals (CI) for rates were constructed using Clopper-Pearson method. Percentages have been rounded off. The participant in the 'Stage 1 Cohort 2 (S1C2): Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the efficacy analyses.

Time frame:
Up to 50.4 months
Reported as:
Number · percentage of participants
Stage 1: Percentage of Participants With Objective Response (OR) as Determined by Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1)
percentage of participantsStage 1 Cohort 1: Control (Atezolizumab)Stage 1 Cohort 1: Atezolizumab + CobimetinibStage 1 Cohort 1: Atezolizumab + CEA-TCBStage 1 Cohort 1: Atezolizumab + TiragolumabStage 1 Cohort 2: Control (Docetaxel)Stage 1 Cohort 2: Atezolizumab + CobimetinibStage 1 Cohort 2: Atezolizumab + CEA-TCBStage 1 Cohort 2: Atezolizumab + CPI-444Stage 1 Cohort 2: Docetaxel + AtezolizumabStage 1 Cohort 2: Atezolizumab + IpatasertibStage 1 Cohort 2: Atezolizumab + BevacizumabStage 1 Cohort 2: Atezolizumab + Bevacizumab + RadiotherapyStage 1 Cohort 2: Atezolizumab + SGStage 1 Cohort 2: Atezolizumab + EvolocumabStage 1 Cohort 2: Atezolizumab + Camonsertib
Stage 1: Percentage of Participants With Objective Response (OR) as Determined by Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1)33.3 (0.84 to 90.57)0 (0.00 to 52.18)100 (2.50 to 100.00)0 (0.00 to 97.50)13.1 (5.84 to 24.22)0 (0.00 to 21.80)0 (0.00 to 97.50)6.7 (0.17 to 31.95)6.3 (0.16 to 30.23)6.7 (0.82 to 22.07)20.0 (9.05 to 35.65)16.7 (6.37 to 32.81)6.7 (0.82 to 22.07)3.2 (0.08 to 16.70)0 (0.00 to 36.94)
Statistical analysis
  • Stage 1 Cohort 1: Control (Atezolizumab) vs Stage 1 Cohort 1: Atezolizumab + Cobimetinib · Difference in overall response rates: -33.33 · 95% CI -100.00 to 46.68
  • Stage 1 Cohort 2: Control (Docetaxel) vs Stage 1 Cohort 2: Atezolizumab + Cobimetinib · Difference in overall response rates: -13.11 · 95% CI -25.74 to -0.49
  • Stage 1 Cohort 2: Control (Docetaxel) vs Stage 1 Cohort 2: Atezolizumab + CPI-444 · Difference in overall response rates: -6.45 · 95% CI -25.80 to 12.91
  • Stage 1 Cohort 2: Control (Docetaxel) vs Stage 1 Cohort 2: Docetaxel + Atezolizumab · Difference in overall response rates: -6.86 · 95% CI -25.38 to 11.66
  • Stage 1 Cohort 2: Control (Docetaxel) vs Stage 1 Cohort 2: Atezolizumab + Ipatasertib · Difference in overall response rates: -6.45 · 95% CI -21.24 to 8.34
  • Stage 1 Cohort 2: Control (Docetaxel) vs Stage 1 Cohort 2: Atezolizumab + Bevacizumab · Difference in overall response rates: 6.89 · 95% CI -10.20 to 23.97
  • Stage 1 Cohort 2: Control (Docetaxel) vs Stage 1 Cohort 2: Atezolizumab + Bevacizumab + Radiotherapy · Difference in overall response rates: 3.55 · 95% CI -13.49 to 20.59
  • Stage 1 Cohort 2: Control (Docetaxel) vs Stage 1 Cohort 2: Atezolizumab + SG · Difference in overall response rates: -6.45 · 95% CI -21.24 to 8.34
  • Stage 1 Cohort 2: Control (Docetaxel) vs Stage 1 Cohort 2: Atezolizumab + Evolocumab · Difference in overall response rates: -9.89 · 95% CI -22.83 to 3.05
  • Stage 1 Cohort 2: Control (Docetaxel) vs Stage 1 Cohort 2: Atezolizumab + Camonsertib · Difference in overall response rates: -13.11 · 95% CI -28.66 to 2.43
SecondaryStage 1: Progression-free Survival (PFS) as Determined by Investigator According to RECIST V1.1

PFS was defined as the time from study treatment initiation to the first occurrence of documented PD, as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum in the study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm or unequivocal progression of existing non-target lesions. Participants who did not have documented PD or death, PFS was censored at the day of the last tumor assessment. Kaplan-Meier (K-M) method was used to estimate PFS. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the efficacy analyses.

Time frame:
From randomization to the first occurrence of PD or death (Up to 48.6 months)
Reported as:
Median · months
Stage 1: Progression-free Survival (PFS) as Determined by Investigator According to RECIST V1.1
monthsStage 1 Cohort 1: Control (Atezolizumab)Stage 1 Cohort 1: Atezolizumab + CobimetinibStage 1 Cohort 1: Atezolizumab + CEA-TCBStage 1 Cohort 1: Atezolizumab + TiragolumabStage 1 Cohort 2: Control (Docetaxel)Stage 1 Cohort 2: Atezolizumab + CobimetinibStage 1 Cohort 2: Atezolizumab + CEA-TCBStage 1 Cohort 2: Atezolizumab + CPI-444Stage 1 Cohort 2: Docetaxel + AtezolizumabStage 1 Cohort 2: Atezolizumab + IpatasertibStage 1 Cohort 2: Atezolizumab + BevacizumabStage 1 Cohort 2: Atezolizumab + Bevacizumab + RadiotherapyStage 1 Cohort 2: Atezolizumab + SGStage 1 Cohort 2: Atezolizumab + EvolocumabStage 1 Cohort 2: Atezolizumab + Camonsertib
Stage 1: Progression-free Survival (PFS) as Determined by Investigator According to RECIST V1.11.51 (1.31 to NA)2.66 (0.69 to NA)6.90 (NA to NA)1.64 (NA to NA)4.83 (4.11 to 5.91)2.43 (1.84 to 6.77)17.48 (NA to NA)2.30 (1.38 to 5.52)5.09 (3.22 to 8.54)2.64 (1.71 to 3.98)6.95 (4.37 to 8.28)7.93 (4.67 to 15.67)5.49 (4.27 to 7.16)2.17 (1.48 to 4.37)3.50 (1.54 to 5.75)
Statistical analysis
  • Stage 1 Cohort 1: Control (Atezolizumab) vs Stage 1 Cohort 1: Atezolizumab + Cobimetinib · Hazard ratio (hr): 1.34 · 95% CI 0.25 to 7.09
  • Stage 1 Cohort 2: Control (Docetaxel) vs Stage 1 Cohort 2: Atezolizumab + Cobimetinib · Hazard ratio (hr): 1.53 · 95% CI 0.80 to 2.91
  • Stage 1 Cohort 2: Control (Docetaxel) vs Stage 1 Cohort 2: Atezolizumab + CPI-444 · Hazard ratio (hr): 1.29 · 95% CI 0.70 to 2.37
  • Stage 1 Cohort 2: Control (Docetaxel) vs Stage 1 Cohort 2: Docetaxel + Atezolizumab · Hazard ratio (hr): 1.06 · 95% CI 0.60 to 1.88
  • Stage 1 Cohort 2: Control (Docetaxel) vs Stage 1 Cohort 2: Atezolizumab + Ipatasertib · Hazard ratio (hr): 1.74 · 95% CI 1.09 to 2.77
  • Stage 1 Cohort 2: Control (Docetaxel) vs Stage 1 Cohort 2: Atezolizumab + Bevacizumab · Hazard ratio (hr): 0.84 · 95% CI 0.55 to 1.30
  • Stage 1 Cohort 2: Control (Docetaxel) vs Stage 1 Cohort 2: Atezolizumab + Bevacizumab + Radiotherapy · Hazard ratio (hr): 0.57 · 95% CI 0.36 to 0.92
  • Stage 1 Cohort 2: Control (Docetaxel) vs Stage 1 Cohort 2: Atezolizumab + SG · Hazard ratio (hr): 0.89 · 95% CI 0.55 to 1.42
  • Stage 1 Cohort 2: Control (Docetaxel) vs Stage 1 Cohort 2: Atezolizumab + Evolocumab · Hazard ratio (hr): 1.80 · 95% CI 1.14 to 2.86
  • Stage 1 Cohort 2: Control (Docetaxel) vs Stage 1 Cohort 2: Atezolizumab + Camonsertib · Hazard ratio (hr): 1.68 · 95% CI 0.79 to 3.61
SecondaryStage 1: PFS Rate at Month 6

PFS was defined as the time from study treatment initiation to the first occurrence of documented PD, as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum in the study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm or unequivocal progression of existing non-target lesions. Participants who did not have documented PD or death, PFS was censored at the day of the last tumor assessment. The KM approach was used to estimate the percentage of participants who were event-free for PFS at Month 6. Percentages have been rounded off. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the efficacy analyses.

Time frame:
At Month 6
Reported as:
Number · percentage of participants
Stage 1: PFS Rate at Month 6
percentage of participantsStage 1 Cohort 1: Control (Atezolizumab)Stage 1 Cohort 1: Atezolizumab + CobimetinibStage 1 Cohort 1: Atezolizumab + CEA-TCBStage 1 Cohort 1: Atezolizumab + TiragolumabStage 1 Cohort 2: Control (Docetaxel)Stage 1 Cohort 2: Atezolizumab + CobimetinibStage 1 Cohort 2: Atezolizumab + CEA-TCBStage 1 Cohort 2: Atezolizumab + CPI-444Stage 1 Cohort 2: Docetaxel + AtezolizumabStage 1 Cohort 2: Atezolizumab + IpatasertibStage 1 Cohort 2: Atezolizumab + BevacizumabStage 1 Cohort 2: Atezolizumab + Bevacizumab + RadiotherapyStage 1 Cohort 2: Atezolizumab + SGStage 1 Cohort 2: Atezolizumab + EvolocumabStage 1 Cohort 2: Atezolizumab + Camonsertib
Stage 1: PFS Rate at Month 633.33 (0.00 to 86.68)20.00 (0.00 to 55.06)100.00 (100.00 to 100.00)NA (NA to NA)36.79 (23.61 to 49.96)29.22 (3.33 to 55.11)100.00 (100.00 to 100.00)26.67 (4.29 to 49.05)37.50 (13.78 to 61.22)20.00 (5.69 to 34.31)55.00 (39.58 to 70.42)61.11 (45.19 to 77.04)43.33 (25.60 to 61.07)12.90 (1.10 to 24.70)12.50 (0.00 to 35.42)
Statistical analysis
  • Stage 1 Cohort 1: Control (Atezolizumab) vs Stage 1 Cohort 1: Atezolizumab + Cobimetinib · Difference in event free rate: -13.33 · 95% CI -77.17 to 50.50
  • Stage 1 Cohort 2: Control (Docetaxel) vs Stage 1 Cohort 2: Atezolizumab + Cobimetinib · Difference in event free rate: -7.56 · 95% CI -36.61 to 21.48
  • Stage 1 Cohort 2: Control (Docetaxel) vs Stage 1 Cohort 2: Atezolizumab + CPI-444 · Difference in event free rate: -10.12 · 95% CI -36.09 to 15.85
  • Stage 1 Cohort 2: Control (Docetaxel) vs Stage 1 Cohort 2: Docetaxel + Atezolizumab · Difference in event free rate: 0.71 · 95% CI -26.42 to 27.85
  • Stage 1 Cohort 2: Control (Docetaxel) vs Stage 1 Cohort 2: Atezolizumab + Ipatasertib · Difference in event free rate: -16.79 · 95% CI -36.24 to 2.67
  • Stage 1 Cohort 2: Control (Docetaxel) vs Stage 1 Cohort 2: Atezolizumab + Bevacizumab · Difference in event free rate: 18.21 · 95% CI -2.07 to 38.50
  • Stage 1 Cohort 2: Control (Docetaxel) vs Stage 1 Cohort 2: Atezolizumab + Bevacizumab + Radiotherapy · Difference in event free rate: 24.33 · 95% CI 3.66 to 44.99
  • Stage 1 Cohort 2: Control (Docetaxel) vs Stage 1 Cohort 2: Atezolizumab + SG · Difference in event free rate: 6.55 · 95% CI -15.54 to 28.64
  • Stage 1 Cohort 2: Control (Docetaxel) vs Stage 1 Cohort 2: Atezolizumab + Evolocumab · Difference in event free rate: -23.88 · 95% CI -41.57 to -6.19
  • Stage 1 Cohort 2: Control (Docetaxel) vs Stage 1 Cohort 2: Atezolizumab + Camonsertib · Difference in event free rate: -24.29 · 95% CI -50.72 to 2.15
SecondaryStage 1: Overall Survival (OS)

OS was defined as the time from randomization to death from any cause. Participants who were still alive at the time of OS analysis were censored at the last date they were known to be alive. K-M method was used to estimate OS. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the efficacy analyses.

Time frame:
From randomization to death (Up to 67 months)
Reported as:
Median · months
Stage 1: Overall Survival (OS)
monthsStage 1 Cohort 1: Control (Atezolizumab)Stage 1 Cohort 1: Atezolizumab + CobimetinibStage 1 Cohort 1: Atezolizumab + CEA-TCBStage 1 Cohort 1: Atezolizumab + TiragolumabStage 1 Cohort 2: Control (Docetaxel)Stage 1 Cohort 2: Atezolizumab + CobimetinibStage 1 Cohort 2: Atezolizumab + CEA-TCBStage 1 Cohort 2: Atezolizumab + CPI-444Stage 1 Cohort 2: Docetaxel + AtezolizumabStage 1 Cohort 2: Atezolizumab + IpatasertibStage 1 Cohort 2: Atezolizumab + BevacizumabStage 1 Cohort 2: Atezolizumab + Bevacizumab + RadiotherapyStage 1 Cohort 2: Atezolizumab + SGStage 1 Cohort 2: Atezolizumab + EvolocumabStage 1 Cohort 2: Atezolizumab + Camonsertib
Stage 1: Overall Survival (OS)2.96 (2.30 to NA)32.66 (10.94 to NA)NA (NA to NA)3.48 (NA to NA)9.63 (8.34 to 14.78)7.75 (1.91 to 16.56)17.48 (NA to NA)11.53 (2.07 to 17.22)9.40 (4.63 to 23.59)12.45 (5.59 to 15.51)13.70 (10.61 to 21.06)16.92 (9.76 to 33.71)12.48 (7.62 to 17.64)9.10 (7.82 to 14.55)NA (6.21 to NA)
Statistical analysis
  • Stage 1 Cohort 1: Control (Atezolizumab) vs Stage 1 Cohort 1: Atezolizumab + Cobimetinib · Hazard ratio (hr): 0.64 · 95% CI 0.10 to 4.11
  • Stage 1 Cohort 2: Control (Docetaxel) vs Stage 1 Cohort 2: Atezolizumab + Cobimetinib · Hazard ratio (hr): 1.60 · 95% CI 0.80 to 3.20
  • Stage 1 Cohort 2: Control (Docetaxel) vs Stage 1 Cohort 2: Atezolizumab + CPI-444 · Hazard ratio (hr): 0.94 · 95% CI 0.49 to 1.82
  • Stage 1 Cohort 2: Control (Docetaxel) vs Stage 1 Cohort 2: Docetaxel + Atezolizumab · Hazard ratio (hr): 0.97 · 95% CI 0.51 to 1.85
  • Stage 1 Cohort 2: Control (Docetaxel) vs Stage 1 Cohort 2: Atezolizumab + Ipatasertib · Hazard ratio (hr): 1.05 · 95% CI 0.64 to 1.75
  • Stage 1 Cohort 2: Control (Docetaxel) vs Stage 1 Cohort 2: Atezolizumab + Bevacizumab · Hazard ratio (hr): 0.73 · 95% CI 0.46 to 1.15
  • Stage 1 Cohort 2: Control (Docetaxel) vs Stage 1 Cohort 2: Atezolizumab + Bevacizumab + Radiotherapy · Hazard ratio (hr): 0.54 · 95% CI 0.32 to 0.90
  • Stage 1 Cohort 2: Control (Docetaxel) vs Stage 1 Cohort 2: Atezolizumab + SG · Hazard ratio (hr): 0.95 · 95% CI 0.59 to 1.54
  • Stage 1 Cohort 2: Control (Docetaxel) vs Stage 1 Cohort 2: Atezolizumab + Evolocumab · Hazard ratio (hr): 1.29 · 95% CI 0.79 to 2.11
  • Stage 1 Cohort 2: Control (Docetaxel) vs Stage 1 Cohort 2: Atezolizumab + Camonsertib · Hazard ratio (hr): 0.79 · 95% CI 0.28 to 2.23
SecondaryStage 1: OS Rate at Month 6

OS was defined as the time from randomization to death from any cause. Participants who were still alive at the time of OS analysis were censored at the last date they were known to be alive. The Kaplan-Meier approach was used to estimate the percentage of participants who were event-free for OS at Month 6. Percentages have been rounded off. The participant in the 'Stage 1 Cohort 2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the efficacy analyses.

Time frame:
At Month 6
Reported as:
Number · percentage of participants
Stage 1: OS Rate at Month 6
percentage of participantsStage 1 Cohort 1: Control (Atezolizumab)Stage 1 Cohort 1: Atezolizumab + CobimetinibStage 1 Cohort 1: Atezolizumab + CEA-TCBStage 1 Cohort 1: Atezolizumab + TiragolumabStage 1 Cohort 2: Control (Docetaxel)Stage 1 Cohort 2: Atezolizumab + CobimetinibStage 1 Cohort 2: Atezolizumab + CEA-TCBStage 1 Cohort 2: Atezolizumab + CPI-444Stage 1 Cohort 2: Docetaxel + AtezolizumabStage 1 Cohort 2: Atezolizumab + IpatasertibStage 1 Cohort 2: Atezolizumab + BevacizumabStage 1 Cohort 2: Atezolizumab + Bevacizumab + RadiotherapyStage 1 Cohort 2: Atezolizumab + SGStage 1 Cohort 2: Atezolizumab + EvolocumabStage 1 Cohort 2: Atezolizumab + Camonsertib
Stage 1: OS Rate at Month 633.33 (0.00 to 86.68)100.00 (100.00 to 100.00)100.00 (100.00 to 100.00)NA (NA to NA)78.34 (67.47 to 89.20)53.85 (26.02 to 81.67)100.00 (100.00 to 100.00)60.00 (35.21 to 84.79)68.18 (45.06 to 91.30)66.92 (49.21 to 84.64)82.50 (70.72 to 94.28)81.82 (68.66 to 94.98)79.62 (65.04 to 94.19)75.62 (59.87 to 91.37)87.50 (64.58 to 100.00)
Statistical analysis
  • Stage 1 Cohort 1: Control (Atezolizumab) vs Stage 1 Cohort 1: Atezolizumab + Cobimetinib · Difference in event free rate: 66.67 · 95% CI 13.32 to 120.01
  • Stage 1 Cohort 2: Control (Docetaxel) vs Stage 1 Cohort 2: Atezolizumab + Cobimetinib · Difference in event free rate: -24.49 · 95% CI -54.36 to 5.38
  • Stage 1 Cohort 2: Control (Docetaxel) vs Stage 1 Cohort 2: Atezolizumab + CPI-444 · Difference in event free rate: -18.34 · 95% CI -45.41 to 8.73
  • Stage 1 Cohort 2: Control (Docetaxel) vs Stage 1 Cohort 2: Docetaxel + Atezolizumab · Difference in event free rate: -10.15 · 95% CI -35.70 to 15.39
  • Stage 1 Cohort 2: Control (Docetaxel) vs Stage 1 Cohort 2: Atezolizumab + Ipatasertib · Difference in event free rate: -11.41 · 95% CI -32.20 to 9.37
  • Stage 1 Cohort 2: Control (Docetaxel) vs Stage 1 Cohort 2: Atezolizumab + Bevacizumab · Difference in event free rate: 4.16 · 95% CI -11.86 to 20.19
  • Stage 1 Cohort 2: Control (Docetaxel) vs Stage 1 Cohort 2: Atezolizumab + Bevacizumab + Radiotherapy · Difference in event free rate: 3.48 · 95% CI -13.59 to 20.55
  • Stage 1 Cohort 2: Control (Docetaxel) vs Stage 1 Cohort 2: Atezolizumab + SG · Difference in event free rate: 1.28 · 95% CI -16.90 to 19.46
  • Stage 1 Cohort 2: Control (Docetaxel) vs Stage 1 Cohort 2: Atezolizumab + Evolocumab · Difference in event free rate: -2.72 · 95% CI -21.86 to 16.42
  • Stage 1 Cohort 2: Control (Docetaxel) vs Stage 1 Cohort 2: Atezolizumab + Camonsertib · Difference in event free rate: 9.16 · 95% CI -16.20 to 34.53
SecondaryStage 1: Duration of Response (DOR), as Determined by Investigator According to RECIST V1.1

DOR was defined as the time from the first occurrence of a documented OR until the time of documented PD or death from any cause, whichever occurred first as per investigator assessment using RECIST v1.1. DOR was calculated for participants who had a best confirmed OR of CR/PR. CR and PR were defined as outlined in the description for ORR outcome measure. PD=at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm or unequivocal progression of existing non-target lesions. Participants who did not have documented PD or death, DOR was censored at the day of the last tumor assessment. K-M method was used to estimate DOR. The participant in the 'S1C2: Idasanutlin + Docetaxel' arm did not receive study treatment and was therefore excluded from the efficacy analyses.

Time frame:
From first occurrence of a documented OR until the time of documented PD or death (Up to 50.4 months)
Reported as:
Median · months
Stage 1: Duration of Response (DOR), as Determined by Investigator According to RECIST V1.1
monthsStage 1 Cohort 1: Control (Atezolizumab)Stage 1 Cohort 1: Atezolizumab + CobimetinibStage 1 Cohort 1: Atezolizumab + CEA-TCBStage 1 Cohort 1: Atezolizumab + TiragolumabStage 1 Cohort 2: Control (Docetaxel)Stage 1 Cohort 2: Atezolizumab + CobimetinibStage 1 Cohort 2: Atezolizumab + CEA-TCBStage 1 Cohort 2: Atezolizumab + CPI-444Stage 1 Cohort 2: Docetaxel + AtezolizumabStage 1 Cohort 2: Atezolizumab + IpatasertibStage 1 Cohort 2: Atezolizumab + BevacizumabStage 1 Cohort 2: Atezolizumab + Bevacizumab + RadiotherapyStage 1 Cohort 2: Atezolizumab + SGStage 1 Cohort 2: Atezolizumab + EvolocumabStage 1 Cohort 2: Atezolizumab + Camonsertib
Stage 1: Duration of Response (DOR), as Determined by Investigator According to RECIST V1.130.39 (NA to NA)—5.36 (NA to NA)—7.03 (3.48 to NA)——19.09 (NA to NA)16.20 (NA to NA)4.17 (1.41 to NA)14.54 (5.13 to 16.62)20.99 (11.10 to NA)5.36 (4.17 to NA)23.26 (NA to NA)—
Statistical analysis
  • Stage 1 Cohort 2: Control (Docetaxel) vs Stage 1 Cohort 2: Atezolizumab + CPI-444 · Hazard ratio (hr): 0.56 · 95% CI 0.06 to 5.23
  • Stage 1 Cohort 2: Control (Docetaxel) vs Stage 1 Cohort 2: Docetaxel + Atezolizumab · Hazard ratio (hr): 0.56 · 95% CI 0.06 to 5.23
  • Stage 1 Cohort 2: Control (Docetaxel) vs Stage 1 Cohort 2: Atezolizumab + Ipatasertib · Hazard ratio (hr): 3.17 · 95% CI 0.52 to 19.32
  • Stage 1 Cohort 2: Control (Docetaxel) vs Stage 1 Cohort 2: Atezolizumab + Bevacizumab · Hazard ratio (hr): 0.69 · 95% CI 0.21 to 2.23
  • Stage 1 Cohort 2: Control (Docetaxel) vs Stage 1 Cohort 2: Atezolizumab + Bevacizumab + Radiotherapy · Hazard ratio (hr): 0.33 · 95% CI 0.07 to 1.45
  • Stage 1 Cohort 2: Control (Docetaxel) vs Stage 1 Cohort 2: Atezolizumab + SG · Hazard ratio (hr): 2.19 · 95% CI 0.36 to 13.25
  • Stage 1 Cohort 2: Control (Docetaxel) vs Stage 1 Cohort 2: Atezolizumab + Evolocumab · Hazard ratio (hr): 0.56 · 95% CI 0.06 to 5.23
SecondaryStage 1: Percentage of Participants With Disease Control (DC), as Determined by Investigator According to RECIST V1.1

DC was defined as stable disease (SD) for ≥ 12 weeks or a CR or PR, as determined by the investigator according to RECIST v1.1 Disease control rate (DCR) was defined as the percentage of participants with DC. CR was defined as the disappearance of all target \& non-target lesions. Any pathological lymph nodes (whether target or non-target) have a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD=at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm or unequivocal progression of existing non-target lesions. Percentages have been rounded off.

Time frame:
Up to 50.4 months
Reported as:
Number · percentage of participants
Stage 1: Percentage of Participants With Disease Control (DC), as Determined by Investigator According to RECIST V1.1
percentage of participantsStage 1 Cohort 1: Control (Atezolizumab)Stage 1 Cohort 1: Atezolizumab + CobimetinibStage 1 Cohort 1: Atezolizumab + CEA-TCBStage 1 Cohort 1: Atezolizumab + TiragolumabStage 1 Cohort 2: Control (Docetaxel)Stage 1 Cohort 2: Atezolizumab + CobimetinibStage 1 Cohort 2: Atezolizumab + CEA-TCBStage 1 Cohort 2: Atezolizumab + CPI-444Stage 1 Cohort 2: Docetaxel + AtezolizumabStage 1 Cohort 2: Atezolizumab + IpatasertibStage 1 Cohort 2: Atezolizumab + BevacizumabStage 1 Cohort 2: Atezolizumab + Bevacizumab + RadiotherapyStage 1 Cohort 2: Atezolizumab + SGStage 1 Cohort 2: Atezolizumab + EvolocumabStage 1 Cohort 2: Atezolizumab + Camonsertib
Stage 1: Percentage of Participants With Disease Control (DC), as Determined by Investigator According to RECIST V1.133.3 (0.84 to 90.57)40.0 (5.27 to 85.34)100 (2.50 to 100.00)0 (0.00 to 97.50)57.4 (44.06 to 69.96)33.3 (11.82 to 61.62)100 (2.50 to 100.00)40.0 (16.34 to 67.71)56.3 (29.88 to 80.25)36.7 (19.93 to 56.14)65.0 (48.32 to 79.37)69.4 (51.89 to 83.65)66.7 (47.19 to 82.71)41.9 (24.55 to 60.92)37.5 (8.52 to 75.51)
SecondaryStages 1 and 2: Number of Participants With Adverse Events (AEs)

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptoms, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. SAEs = Serious AEs; AESIs = Adverse Events of Special Interest.

Time frame:
From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months)
Reported as:
Count of participants · Participants
Stages 1 and 2: Number of Participants With Adverse Events (AEs)
ParticipantsStage 1 Cohort 1: Control (Atezolizumab)Stage 1 Cohort 1: Atezolizumab + CobimetinibStage 1 Cohort 1: Atezolizumab + CEA-TCBStage 1 Cohort 1: Atezolizumab + TiragolumabStage 1 Cohort 2: Control (Docetaxel)Stage 1 Cohort 2: Atezolizumab + CobimetinibStage 1 Cohort 2: Atezolizumab + CEA-TCBStage 1 Cohort 2: Atezolizumab + CPI-444Stage 1 Cohort 2: Docetaxel + AtezolizumabStage 1 Cohort 2: Atezolizumab + IpatasertibStage 1 Cohort 2: Atezolizumab + BevacizumabStage 1 Cohort 2: Atezolizumab + Bevacizumab + RadiotherapyStage 1 Cohort 2: Atezolizumab + SGStage 1 Cohort 2: Atezolizumab + EvolocumabStage 1 Cohort 2: Atezolizumab + CamonsertibStage 2 Cohort 1: Carboplatin + Pemetrexed + AtezolizumabStage 2 Cohort 2: Docetaxel + AtezolizumabStage 2 Cohort 2: Atezolizumab + Linagliptin
Stages 1 and 2: Number of Participants With Adverse Events (AEs)35116015115163038423030823119

Adverse events

Collected over From baseline until 30 days (for AEs) or 135 days (for SAEs & AESIs) after the last dose of study treatment or until initiation of new systemic anti-cancer therapy, whichever occurred first (Stage 1: up to 54.8 months; Stage 2: up to 43.1 months) All-cause mortality: Stage 1: Up to approximately 67 months; Stage 2: Up to approximately 45.8 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Stage 1 Cohort 1: Control (Atezolizumab)3/3 (100%)2/3 (66.7%)3/3 (100%)
Stage 1 Cohort 1: Atezolizumab + Cobimetinib3/5 (60%)4/5 (80%)5/5 (100%)
Stage 1 Cohort 1: Atezolizumab + CEA-TCB0/1 (0%)1/1 (100%)1/1 (100%)
Stage 1 Cohort 1: Atezolizumab + Tiragolumab1/1 (100%)1/1 (100%)1/1 (100%)
Stage 1 Cohort 2: Control (Docetaxel)36/66 (54.5%)20/61 (32.8%)58/61 (95.1%)
Stage 1 Cohort 2: Atezolizumab + Cobimetinib10/15 (66.7%)8/15 (53.3%)13/15 (86.7%)
Stage 1 Cohort 2: Atezolizumab + CEA-TCB1/1 (100%)1/1 (100%)1/1 (100%)
Stage 1 Cohort 2: Atezolizumab + CPI-44410/16 (62.5%)8/15 (53.3%)14/15 (93.3%)
Stage 1 Cohort 2: Docetaxel + Atezolizumab10/18 (55.6%)5/16 (31.3%)16/16 (100%)
Stage 1 Cohort 2: Atezolizumab + Ipatasertib14/31 (45.2%)13/30 (43.3%)30/30 (100%)
Stage 1 Cohort 2: Atezolizumab + Bevacizumab22/41 (53.7%)13/40 (32.5%)36/40 (90%)
Stage 1 Cohort 2: Atezolizumab + Bevacizumab + Radiotherapy23/45 (51.1%)17/43 (39.5%)41/43 (95.3%)
Stage 1 Cohort 2: Atezolizumab + SG19/30 (63.3%)14/30 (46.7%)30/30 (100%)
Stage 1 Cohort 2: Atezolizumab + Evolocumab25/32 (78.1%)10/31 (32.3%)29/31 (93.5%)
Stage 1 Cohort 2: Atezolizumab + Camonsertib4/8 (50%)4/8 (50%)8/8 (100%)
Stage 2 Cohort 1: Carboplatin + Pemetrexed + Atezolizumab0/2 (0%)1/2 (50%)2/2 (100%)
Stage 2 Cohort 2: Docetaxel + Atezolizumab29/33 (87.9%)13/32 (40.6%)30/32 (93.8%)
Stage 2 Cohort 2: Atezolizumab + Linagliptin19/22 (86.4%)6/20 (30%)18/20 (90%)
Most frequent serious events
Showing 10 of 117
Most frequent serious events
EventStage 1 Cohort 1: Control (Atezolizumab)Stage 1 Cohort 1: Atezolizumab + CobimetinibStage 1 Cohort 1: Atezolizumab + CEA-TCBStage 1 Cohort 1: Atezolizumab + TiragolumabStage 1 Cohort 2: Control (Docetaxel)Stage 1 Cohort 2: Atezolizumab + CobimetinibStage 1 Cohort 2: Atezolizumab + CEA-TCBStage 1 Cohort 2: Atezolizumab + CPI-444Stage 1 Cohort 2: Docetaxel + AtezolizumabStage 1 Cohort 2: Atezolizumab + IpatasertibStage 1 Cohort 2: Atezolizumab + BevacizumabStage 1 Cohort 2: Atezolizumab + Bevacizumab + RadiotherapyStage 1 Cohort 2: Atezolizumab + SGStage 1 Cohort 2: Atezolizumab + EvolocumabStage 1 Cohort 2: Atezolizumab + CamonsertibStage 2 Cohort 1: Carboplatin + Pemetrexed + AtezolizumabStage 2 Cohort 2: Docetaxel + AtezolizumabStage 2 Cohort 2: Atezolizumab + Linagliptin
Atrial fibrillationCardiac disorders0/30/50/10/10/610/151/10/150/161/301/400/431/300/310/80/21/320/20
ColitisGastrointestinal disorders0/30/51/10/10/610/150/10/150/161/300/400/431/300/310/80/20/320/20
COVID-19Infections and infestations0/30/50/11/10/610/150/10/150/161/301/401/431/302/311/80/20/321/20
Respiratory tract infectionInfections and infestations0/30/50/11/10/610/150/10/150/161/301/401/431/300/310/80/21/320/20
Spinal fractureInjury, poisoning and procedural complications0/31/50/10/10/610/151/10/150/160/300/400/430/300/310/80/20/320/20
Transaminases increasedInvestigations0/30/50/10/10/610/151/10/150/160/300/400/430/300/310/80/20/320/20
InfluenzaInfections and infestations0/30/50/10/10/610/150/10/150/160/300/400/430/300/310/81/20/320/20
AnaemiaBlood and lymphatic system disorders1/30/50/10/10/610/150/10/151/160/300/400/430/300/310/80/20/320/20
Gastric perforationGastrointestinal disorders1/30/50/10/10/610/150/10/150/160/300/400/430/300/310/80/20/320/20
AstheniaGeneral disorders1/30/50/10/11/610/150/11/150/161/301/400/430/300/311/80/21/320/20
Most frequent other events
Showing 10 of 229
Most frequent other events
EventStage 1 Cohort 1: Control (Atezolizumab)Stage 1 Cohort 1: Atezolizumab + CobimetinibStage 1 Cohort 1: Atezolizumab + CEA-TCBStage 1 Cohort 1: Atezolizumab + TiragolumabStage 1 Cohort 2: Control (Docetaxel)Stage 1 Cohort 2: Atezolizumab + CobimetinibStage 1 Cohort 2: Atezolizumab + CEA-TCBStage 1 Cohort 2: Atezolizumab + CPI-444Stage 1 Cohort 2: Docetaxel + AtezolizumabStage 1 Cohort 2: Atezolizumab + IpatasertibStage 1 Cohort 2: Atezolizumab + BevacizumabStage 1 Cohort 2: Atezolizumab + Bevacizumab + RadiotherapyStage 1 Cohort 2: Atezolizumab + SGStage 1 Cohort 2: Atezolizumab + EvolocumabStage 1 Cohort 2: Atezolizumab + CamonsertibStage 2 Cohort 1: Carboplatin + Pemetrexed + AtezolizumabStage 2 Cohort 2: Docetaxel + AtezolizumabStage 2 Cohort 2: Atezolizumab + Linagliptin
AnaemiaBlood and lymphatic system disorders1/30/50/10/121/614/150/15/155/167/302/405/4314/306/317/82/210/323/20
ConstipationGastrointestinal disorders1/32/50/10/12/611/151/13/151/164/306/406/4311/306/312/82/21/324/20
Dry mouthGastrointestinal disorders0/30/50/11/11/611/150/10/151/160/300/401/430/300/310/80/20/322/20
Gastrooesophageal reflux diseaseGastrointestinal disorders0/30/51/10/13/610/150/10/150/161/301/402/431/300/311/80/20/320/20
NauseaGastrointestinal disorders1/30/50/10/112/614/151/12/154/1610/303/404/4312/301/314/80/22/323/20
AstheniaGeneral disorders0/31/50/11/124/610/150/13/155/1611/305/4017/438/304/312/80/214/321/20
FatigueGeneral disorders2/31/51/10/111/612/151/11/154/162/307/405/437/304/312/81/22/322/20
Biliary obstructionHepatobiliary disorders0/30/50/10/10/610/151/10/150/160/300/400/431/300/310/80/20/320/20
Seasonal allergyImmune system disorders0/30/51/10/10/610/150/10/150/160/300/400/430/300/310/80/20/320/20
Escherichia infectionInfections and infestations0/30/50/10/10/610/151/10/150/160/300/400/430/300/310/80/20/320/20

Baseline characteristics

Randomized population included all participants randomized to each treatment arm.

Age, Categorical
Age, Categorical(Participants)Stage 1 Cohort 1: Control (Atezolizumab)Stage 1 Cohort 1: Atezolizumab + CobimetinibStage 1 Cohort 1: Atezolizumab + CEA-TCBStage 1 Cohort 1: Atezolizumab + TiragolumabStage 1 Cohort 2: Control (Docetaxel)Stage 1 Cohort 2: Atezolizumab + CobimetinibStage 1 Cohort 2: Atezolizumab + CEA-TCBStage 1 Cohort 2: Atezolizumab + CPI-444Stage 1 Cohort 2: Docetaxel + AtezolizumabStage 1 Cohort 2: Atezolizumab + IpatasertibStage 1 Cohort 2: Idasanutlin + DocetaxelStage 1 Cohort 2: Atezolizumab + BevacizumabStage 1 Cohort 2: Atezolizumab + Bevacizumab + RadiotherapyStage 1 Cohort 2: Atezolizumab + SGStage 1 Cohort 2: Atezolizumab + EvolocumabStage 1 Cohort 2: Atezolizumab + CamonsertibStage 2 Cohort 1: Carboplatin + Pemetrexed + AtezolizumabStage 2 Cohort 2: Docetaxel + AtezolizumabStage 2 Cohort 2: Atezolizumab + LinagliptinTotal
Stage 1 — <=18 years0000000000000000———0
Stage 1 — Between 18 and 65 years02003513011816123171396———154
Stage 1 — >=65 years33113121510150182817232———160
Stage 2 — <=18 years————————————————0000
Stage 2 — Between 18 and 65 years————————————————0201232
Stage 2 — >=65 years————————————————2131025
Sex: Female, Male
Sex: Female, Male(Participants)Stage 1 Cohort 1: Control (Atezolizumab)Stage 1 Cohort 1: Atezolizumab + CobimetinibStage 1 Cohort 1: Atezolizumab + CEA-TCBStage 1 Cohort 1: Atezolizumab + TiragolumabStage 1 Cohort 2: Control (Docetaxel)Stage 1 Cohort 2: Atezolizumab + CobimetinibStage 1 Cohort 2: Atezolizumab + CEA-TCBStage 1 Cohort 2: Atezolizumab + CPI-444Stage 1 Cohort 2: Docetaxel + AtezolizumabStage 1 Cohort 2: Atezolizumab + IpatasertibStage 1 Cohort 2: Idasanutlin + DocetaxelStage 1 Cohort 2: Atezolizumab + BevacizumabStage 1 Cohort 2: Atezolizumab + Bevacizumab + RadiotherapyStage 1 Cohort 2: Atezolizumab + SGStage 1 Cohort 2: Atezolizumab + EvolocumabStage 1 Cohort 2: Atezolizumab + CamonsertibStage 2 Cohort 1: Carboplatin + Pemetrexed + AtezolizumabStage 2 Cohort 2: Docetaxel + AtezolizumabStage 2 Cohort 2: Atezolizumab + LinagliptinTotal
Stage 1 — Female1100185076811011891———86
Stage 1 — Male241148101912230313422237———228
Stage 2 — Female————————————————09615
Stage 2 — Male————————————————2241642
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Stage 1 Cohort 1: Control (Atezolizumab)Stage 1 Cohort 1: Atezolizumab + CobimetinibStage 1 Cohort 1: Atezolizumab + CEA-TCBStage 1 Cohort 1: Atezolizumab + TiragolumabStage 1 Cohort 2: Control (Docetaxel)Stage 1 Cohort 2: Atezolizumab + CobimetinibStage 1 Cohort 2: Atezolizumab + CEA-TCBStage 1 Cohort 2: Atezolizumab + CPI-444Stage 1 Cohort 2: Docetaxel + AtezolizumabStage 1 Cohort 2: Atezolizumab + IpatasertibStage 1 Cohort 2: Idasanutlin + DocetaxelStage 1 Cohort 2: Atezolizumab + BevacizumabStage 1 Cohort 2: Atezolizumab + Bevacizumab + RadiotherapyStage 1 Cohort 2: Atezolizumab + SGStage 1 Cohort 2: Atezolizumab + EvolocumabStage 1 Cohort 2: Atezolizumab + CamonsertibStage 2 Cohort 1: Carboplatin + Pemetrexed + AtezolizumabStage 2 Cohort 2: Docetaxel + AtezolizumabStage 2 Cohort 2: Atezolizumab + LinagliptinTotal
Stage 1 — Hispanic or Latino0000200000010200———5
Stage 1 — Not Hispanic or Latino3511501411513191273121206———228
Stage 1 — Unknown or Not Reported000014101512013147122———81
Stage 2 — Hispanic or Latino————————————————0123
Stage 2 — Not Hispanic or Latino————————————————2221640
Stage 2 — Unknown or Not Reported————————————————010414
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Stage 1 Cohort 1: Control (Atezolizumab)Stage 1 Cohort 1: Atezolizumab + CobimetinibStage 1 Cohort 1: Atezolizumab + CEA-TCBStage 1 Cohort 1: Atezolizumab + TiragolumabStage 1 Cohort 2: Control (Docetaxel)Stage 1 Cohort 2: Atezolizumab + CobimetinibStage 1 Cohort 2: Atezolizumab + CEA-TCBStage 1 Cohort 2: Atezolizumab + CPI-444Stage 1 Cohort 2: Docetaxel + AtezolizumabStage 1 Cohort 2: Atezolizumab + IpatasertibStage 1 Cohort 2: Idasanutlin + DocetaxelStage 1 Cohort 2: Atezolizumab + BevacizumabStage 1 Cohort 2: Atezolizumab + Bevacizumab + RadiotherapyStage 1 Cohort 2: Atezolizumab + SGStage 1 Cohort 2: Atezolizumab + EvolocumabStage 1 Cohort 2: Atezolizumab + CamonsertibStage 2 Cohort 1: Carboplatin + Pemetrexed + AtezolizumabStage 2 Cohort 2: Docetaxel + AtezolizumabStage 2 Cohort 2: Atezolizumab + LinagliptinTotal
Stage 1 — American Indian or Alaska Native0000000100000000———1
Stage 1 — Asian131015804270514593———77
Stage 1 — Native Hawaiian or Other Pacific Islander0000000000000000———0
Stage 1 — Black or African American0000010100000000———2
Stage 1 — White22013851911141271819113———162
Stage 1 — More than one race0000000000000000———0
Stage 1 — Unknown or Not Reported00001310151009136122———72
Stage 2 — American Indian or Alaska Native————————————————0000
Stage 2 — Asian————————————————1012
Stage 2 — Native Hawaiian or Other Pacific Islander————————————————0000
Stage 2 — Black or African American————————————————0101
Stage 2 — White————————————————1241843
Stage 2 — More than one race————————————————0000
Stage 2 — Unknown or Not Reported————————————————08311
08

Study locations

29 sites
  • Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley
    Las Vegas, Nevada 89169, United States
  • Columbia University Medical Center
    New York, New York 10032, United States
  • University Hospitals Case Medical Center
    Cleveland, Ohio 44106, United States
  • SCRI Oncology Partners
    Nashville, Tennessee 37203, United States
  • Blacktown Hospital
    Blacktown, New South Wales 2148, Australia
  • Peter Mac Callum Cancer Center
    East Melbourne, Victoria 3002, Australia
  • Centre Georges Francois Leclerc
    Dijon, 21079, France
  • Centre Léon Bérard
    Lyon, 69008, France
  • Hopital de la Timone
    Marseille, 13005, France
  • Institut Régional du Cancer de Montpellier
    Montpellier, 34298, France
  • Institut De Cancerologie De L'Ouest
    Saint-Herblain, 44115, France
  • Institut Universitaire du Cancer de Toulouse-Oncopole
    Toulouse, 31100, France
  • Rambam Medical Center
    Haifa, 3109601, Israel
  • Rabin Medical Center
    Petah Tikva, 4941492, Israel
  • Chaim Sheba Medical Center
    Ramat Gan, 52620-00, Israel
  • Seoul National University Hospital
    Seoul, 03080, South Korea
  • Severance Hospital, Yonsei University Health System
    Seoul, 03722, South Korea
  • Korea University Guro Hospital
    Seoul, 08308, South Korea
  • University of Ulsan College of Medicine - Asan Medical Center (AMC) - Asan Cancer Center (ACC)
    Songpa-gu, 05505, South Korea
  • Clínica Universidad de Navarra
    Pamplona, Navarre 31008, Spain
  • Hospital Universitari Vall d'Hebron
    Barcelona, 08035, Spain
  • Hospital Universitario La Paz
    Madrid, 280146, Spain
  • Fundación Jimenez Díaz
    Madrid, 28040, Spain
  • Hospital Universitario HM Sanchinarro-CIOCC
    Madrid, 28050, Spain
  • Hospital Regional Universitario de Malaga
    Málaga, 29010, Spain
  • Hospital Clinico Universitario de Valencia
    Valencia, 46010, Spain
  • Barts Cancer Institute
    London, E1 2AT, United Kingdom
  • The Newcastle upon Tyne Hospitals NHS Foundation Trust
    Newcastle upon Tyne, NE1 4LP, United Kingdom
  • Royal Marsden Hospital
    Sutton, SM2 5PT, United Kingdom
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03337698
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Nov 9, 2017
Start date
Dec 27, 2017
Primary completion
Oct 14, 2025
Completion
Nov 25, 2025
Results posted
May 12, 2026
Last update
May 12, 2026

Study contacts

Clinical Trials
study director · Hoffmann-La Roche

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Cobimetinib · Cibisatamab · Docetaxel · Ciforadenant · Pemetrexed · Carboplatin · Gemcitabine · Linagliptin · Ipatasertib · Bevacizumab · Sacituzumab govitecan · Evolocumab · Tiragolumab · Zanzalintinib · Camonsertib

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