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CompletedNCT03563716Updated May 4, 2026Results posted

A Study of Tiragolumab in Combination With Atezolizumab in Chemotherapy-Naïve Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

A Phase 2 interventional study of Atezolizumab and Tiragolumab in Non-small Cell Lung Cancer, sponsored by Genentech, Inc.. Completed at 40 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-04.

Sponsored by Genentech, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
135
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study will evaluate the safety and efficacy of tiragolumab plus atezolizumab compared with placebo plus atezolizumab in chemotherapy-naive patients with locally advanced unresectable or metastatic PD-L1-selected non-small cell lung cancer (NSCLC), excluding patients with a sensitizing EGFR mutation or ALK translocation.

02

Conditions studied

  • Non-small Cell Lung Cancer
03

In context

Carcinoma, Non-Small-Cell Lung

6,485 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,630 are open to participants now.

This study's enrollment of 135 is above the median of 62 across 5,211 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Genentech, Inc. is the lead sponsor of 507 studies on the registry; 23 are open to participants now.

Of its 90 completed or terminated interventional studies of FDA-regulated products, 50 (56%) 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

Inclusion criteria

  • ECOG Performance Status of 0 or 1
  • Histologically or cytologically documented locally advanced unresectable NSCLC, recurrent, or metastatic NSCLC of either squamous or non-squamous histology
  • No prior systemic treatment for locally advanced unresectable or metastatic NSCLC
  • Tumor PD-L1 expression
  • Measurable disease, as defined by RECIST v1.1
  • Life expectancy >=12 weeks
  • Adequate hematologic and end-organ function
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs
  • For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm

Exclusion criteria

Exclusion Criteria:

Cancer-Specific Exclusions:

  • Patients with NSCLC known to have a sensitizing mutation in the EGFR gene or an ALK fusion oncogene
  • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
  • Spinal cord compression not definitively treated with surgery and/or radiation, and/or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for >=2 weeks prior to screening
  • History of leptomeningeal disease
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
  • Uncontrolled tumor-related pain
  • Uncontrolled hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab
  • Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and/or treated with expected curative outcome

General Medical Exclusions:

  • Pregnant and lactating women
  • Significant cardiovascular disease
  • Severe infections within 4 weeks prior to randomization
  • Major surgical procedure other than for diagnosis within 4 weeks prior to randomization

Treatment-Specific Exclusions:

  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins; known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
  • History of autoimmune disease
  • Prior allogeneic bone marrow transplantation or solid organ transplantation
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
  • Positive test for human immunodeficiency virus (HIV) and/or active hepatitis B or hepatitis C or active tuberculosis
  • Administration of a live, attenuated vaccine within 4 weeks prior to randomization
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
135 participants (actual)

Study arms

  • Placebo comparator
    Placebo + Atezolizumab

    Participants will receive atezolizumab at a fixed dose of 1200 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle and placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.

    Drug: Atezolizumab · Drug: Placebo

  • Experimental
    Tiragolumab + Atezolizumab

    Participants will receive atezolizumab at a fixed dose of 1200 mg administered by intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle and tiragolumab at a dose of 600 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle.

    Drug: Atezolizumab · Drug: Tiragolumab

Interventions

  • DrugAtezolizumab

    Atezolizumab at a fixed dose of 1200 mg will be administered first by IV infusion Q3W on Day 1 of each 21-day cycle.

    Also known as: Tecentriq

  • DrugTiragolumab

    Tiragolumab at a fixed dose of 600 mg will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.

    Also known as: MTIG7192A

  • DrugPlacebo

    Placebo will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.

06

What researchers measure

Primary outcomes

  1. Objective Response Rate (ORR)

    ORR was defined as a complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target lesions) must 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. Percentages have been rounded off.

    Time frame: From baseline until a total of 80 progression-free survival (PFS) events have occurred (up to approximately 11 months)

  2. Progression-free Survival (PFS)

    PFS was defined as the time from randomization to the first occurrence of 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 SOD at prior timepoints (including baseline) or unequivocal progression of existing non-target lesions. In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥5 mm. Kaplan-Meier (KM) methodology was used to estimate the median PFS.

    Time frame: From baseline until a total of 80 PFS events have occurred (up to approximately 11 months)

Secondary outcomes

  1. Duration of Objective Response (DOR)

    DOR was defined as the time from the first occurrence of a documented objective response (OR) (CR or PR) to PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first. CR was defined as the disappearance of all target and non-target lesions and normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target lesions) must have a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline) or unequivocal progression of existing non-target lesions. In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥5 mm. KM methodology was used to estimate the median DOR.

    Time frame: Up to approximately 36 months

  2. Overall Survival (OS)

    OS was defined as the time from randomization to death from any cause. KM methodology was used to estimate the median OS.

    Time frame: Up to approximately 36 months

  3. Number of Participants With Adverse Events (AEs)

    An AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

    Time frame: From initiation of study drug up to approximately 83.7 months

  4. Minimum Serum Concentration (Cmin) of Tiragolumab

    Time frame: Predose on Day 1 of Cycles 1, 3 and 11 (Cycle length = 21 days)

  5. Cmin of Atezolizumab

    Time frame: Predose on Day 1 of Cycles 1, 3 and 11 (Cycle length = 21 days)

  6. Number of Participants With Treatment-Emergent Anti-drug Antibodies (ADAs) to Tiragolumab

    Participants who received tiragolumab were considered to be treatment-emergent ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following tiragolumab exposure (treatment-induced ADA response), or if they were ADA-positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer units (t.u.) greater than the titer of the baseline sample (treatment-enhanced ADA response). Participants with a positive post-baseline sample has been reported here.

    Time frame: Up to approximately 36 months

  7. Number of Participants With Treatment-Emergent ADAs to Atezolizumab

    Participants who received atezolizumab were considered to be treatment-emergent ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following atezolizumab exposure (treatment-induced ADA response), or if they were ADA-positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer units (t.u.) greater than the titer of the baseline sample (treatment-enhanced ADA response). Participants with a positive post-baseline sample has been reported here.

    Time frame: Up to approximately 36 months

07

Results

Posted Jul 9, 2020

Participant flow

A total of 135 participants with previously untreated, locally advanced, unresectable, or metastatic programmed death-ligand 1 (PD-L1)-selected non-small cell lung cancer (NSCLC) took part in the study at 39 investigative sites across 6 countries from 08 Aug 2018 to 14 Nov 2025.

Participant flow — Overall Study
MilestonePlacebo + AtezolizumabTiragolumab + Atezolizumab
Started6867
Completed00
Not completed6867
Withdrew: Death5751
Withdrew: Lost to follow-up20
Withdrew: Study ended by sponsor614
Withdrew: Withdrawal by subject32

Outcome measures

PrimaryObjective Response Rate (ORR)

ORR was defined as a complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target lesions) must 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. Percentages have been rounded off.

Time frame:
From baseline until a total of 80 progression-free survival (PFS) events have occurred (up to approximately 11 months)
Reported as:
Number · percentage of participants
Objective Response Rate (ORR)
percentage of participantsPlacebo + AtezolizumabTiragolumab + Atezolizumab
Objective Response Rate (ORR)16.2 (6.69 to 25.66)31.3 (19.49 to 43.20)
Statistical analysis
  • Placebo + Atezolizumab vs Tiragolumab + Atezolizumab · Cochran-Mantel-Haenszel · p = 0.0310 · Odds ratio (or): 2.57 · 95% CI 1.07 to 6.1495% confidence interval (CI) for odds ratio was constructed using the Wald method.
PrimaryProgression-free Survival (PFS)

PFS was defined as the time from randomization to the first occurrence of 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 SOD at prior timepoints (including baseline) or unequivocal progression of existing non-target lesions. In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥5 mm. Kaplan-Meier (KM) methodology was used to estimate the median PFS.

Time frame:
From baseline until a total of 80 PFS events have occurred (up to approximately 11 months)
Reported as:
Median · months
Progression-free Survival (PFS)
monthsPlacebo + AtezolizumabTiragolumab + Atezolizumab
Progression-free Survival (PFS)3.58 (2.73 to 4.44)5.42 (4.21 to NA)
Statistical analysis
  • Placebo + Atezolizumab vs Tiragolumab + Atezolizumab · Log Rank · p = 0.0153 · Hazard ratio (hr): 0.57 · 95% CI 0.37 to 0.90Hazard ratios were estimated by Cox regression.
SecondaryDuration of Objective Response (DOR)

DOR was defined as the time from the first occurrence of a documented objective response (OR) (CR or PR) to PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first. CR was defined as the disappearance of all target and non-target lesions and normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target lesions) must have a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline) or unequivocal progression of existing non-target lesions. In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥5 mm. KM methodology was used to estimate the median DOR.

Time frame:
Up to approximately 36 months
Reported as:
Median · months
Duration of Objective Response (DOR)
monthsPlacebo + AtezolizumabTiragolumab + Atezolizumab
Duration of Objective Response (DOR)10.7 (6.0 to 18.8)17.6 (9.1 to 26.1)
SecondaryOverall Survival (OS)

OS was defined as the time from randomization to death from any cause. KM methodology was used to estimate the median OS.

Time frame:
Up to approximately 36 months
Reported as:
Median · months
Overall Survival (OS)
monthsPlacebo + AtezolizumabTiragolumab + Atezolizumab
Overall Survival (OS)14.5 (9.6 to 20.4)23.2 (14.1 to 31.5)
Statistical analysis
  • Placebo + Atezolizumab vs Tiragolumab + Atezolizumab · Log Rank · p = 0.0933 · Hazard ratio (hr): 0.69 · 95% CI 0.44 to 1.07Hazard ratios were estimated by Cox regression.
SecondaryNumber of Participants With Adverse Events (AEs)

An AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Time frame:
From initiation of study drug up to approximately 83.7 months
Reported as:
Count of participants · Participants
Number of Participants With Adverse Events (AEs)
ParticipantsPlacebo + AtezolizumabTiragolumab + Atezolizumab
Number of Participants With Adverse Events (AEs)6666
SecondaryMinimum Serum Concentration (Cmin) of Tiragolumab
Time frame:
Predose on Day 1 of Cycles 1, 3 and 11 (Cycle length = 21 days)
Reported as:
Geometric mean · micrograms per milliliter (μg/mL)
Minimum Serum Concentration (Cmin) of Tiragolumab
micrograms per milliliter (μg/mL)Tiragolumab + Atezolizumab
Predose on Cycle 1 Day 118.6 ± 155.0
Predose on Cycle 3 Day 137.9 ± 67.8
Predose on Cycle 11 Day 163.8 ± 46.3
SecondaryCmin of Atezolizumab
Time frame:
Predose on Day 1 of Cycles 1, 3 and 11 (Cycle length = 21 days)
Reported as:
Geometric mean · μg/mL
Cmin of Atezolizumab
μg/mLPlacebo + AtezolizumabTiragolumab + Atezolizumab
Predose on Cycle 1 Day 169.8 ± 48.357.9 ± 147.0
Predose on Cycle 3 Day 1114 ± 72.895.5 ± 300.5
Predose on Cycle 11 Day 1181 ± 52.1192 ± 40.3
SecondaryNumber of Participants With Treatment-Emergent Anti-drug Antibodies (ADAs) to Tiragolumab

Participants who received tiragolumab were considered to be treatment-emergent ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following tiragolumab exposure (treatment-induced ADA response), or if they were ADA-positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer units (t.u.) greater than the titer of the baseline sample (treatment-enhanced ADA response). Participants with a positive post-baseline sample has been reported here.

Time frame:
Up to approximately 36 months
Reported as:
Count of participants · Participants
Number of Participants With Treatment-Emergent Anti-drug Antibodies (ADAs) to Tiragolumab
ParticipantsTiragolumab + Atezolizumab
Number of Participants With Treatment-Emergent Anti-drug Antibodies (ADAs) to Tiragolumab1
SecondaryNumber of Participants With Treatment-Emergent ADAs to Atezolizumab

Participants who received atezolizumab were considered to be treatment-emergent ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following atezolizumab exposure (treatment-induced ADA response), or if they were ADA-positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer units (t.u.) greater than the titer of the baseline sample (treatment-enhanced ADA response). Participants with a positive post-baseline sample has been reported here.

Time frame:
Up to approximately 36 months
Reported as:
Count of participants · Participants
Number of Participants With Treatment-Emergent ADAs to Atezolizumab
ParticipantsPlacebo + AtezolizumabTiragolumab + Atezolizumab
Number of Participants With Treatment-Emergent ADAs to Atezolizumab2824

Adverse events

Collected over From initiation of study drug up to approximately 83.7 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo + Atezolizumab57/68 (83.8%)28/68 (41.2%)59/68 (86.8%)
Tiragolumab + Atezolizumab51/67 (76.1%)40/67 (59.7%)63/67 (94%)
Most frequent serious events
Showing 10 of 81
Most frequent serious events
EventPlacebo + AtezolizumabTiragolumab + Atezolizumab
PneumoniaInfections and infestations5/689/67
Pleural effusionRespiratory, thoracic and mediastinal disorders1/684/67
ColitisGastrointestinal disorders0/682/67
HepatitisHepatobiliary disorders0/682/67
InfluenzaInfections and infestations0/682/67
Lipase increasedInvestigations0/682/67
HaemoptysisRespiratory, thoracic and mediastinal disorders0/682/67
COVID-19Infections and infestations1/682/67
Diabetic ketoacidosisMetabolism and nutrition disorders0/682/67
Pulmonary embolismRespiratory, thoracic and mediastinal disorders2/680/67
Most frequent other events
Showing 10 of 51
Most frequent other events
EventPlacebo + AtezolizumabTiragolumab + Atezolizumab
ArthralgiaMusculoskeletal and connective tissue disorders12/6821/67
Infusion related reactionInjury, poisoning and procedural complications7/6820/67
AstheniaGeneral disorders18/6819/67
PruritusSkin and subcutaneous tissue disorders11/6819/67
FatigueGeneral disorders11/6817/67
RashSkin and subcutaneous tissue disorders6/6817/67
DyspnoeaRespiratory, thoracic and mediastinal disorders16/6810/67
DiarrhoeaGastrointestinal disorders11/6815/67
Decreased appetiteMetabolism and nutrition disorders15/6815/67
ConstipationGastrointestinal disorders10/6813/67

Baseline characteristics

Intent-to-Treat (ITT) population included all participants randomized in the study.

Age, Continuous
Age, Continuous(years)Placebo + AtezolizumabTiragolumab + AtezolizumabTotal
Mean67.0 ± 9.965.8 ± 10.466.4 ± 10.1
Sex: Female, Male
Sex: Female, Male(Participants)Placebo + AtezolizumabTiragolumab + AtezolizumabTotal
Female202848
Male483987
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Placebo + AtezolizumabTiragolumab + AtezolizumabTotal
Hispanic or Latino011
Not Hispanic or Latino6360123
Unknown or Not Reported5611
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Placebo + AtezolizumabTiragolumab + AtezolizumabTotal
American Indian or Alaska Native000
Asian231841
Native Hawaiian or Other Pacific Islander000
Black or African American000
White404282
More than one race101
Unknown or Not Reported4711
08

Study locations

40 sites
  • Arizona Oncology Associates, PC - HAL
    Tempe, Arizona 85284, United States
  • SCRI Florida Cancer Specialists South
    Fort Myers, Florida 33901, United States
  • Florida Cancer Specialists - NORTH - SCRI - PPDS
    St. Petersburg, Florida 33705, United States
  • Illinois Cancer Specialists
    Arlington Heights, Illinois 60005, United States
  • Illinois Cancer Care
    Peoria, Illinois 61615, United States
  • University of Kansas Medical Center
    Westwood, Kansas 66205, United States
  • Karmanos Cancer Institute
    Detroit, Michigan 48201, United States
  • Research Medical Center
    Kansas City, Missouri 64132, United States
  • SCRI Tennessee Oncology
    Nashville, Tennessee 37203, United States
  • Virginia Cancer Specialists, PC
    Fairfax, Virginia 22031, United States
  • Northwest Cancer Specialists - Vancouver
    Vancouver, Washington 98684, United States
  • ICO Paul Papin
    Angers, 49055, France
  • Institut Bergonié Centre Régional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest
    Bordeaux, 33076, France
  • Centre Georges François Leclerc
    Dijon, 21079, France
  • Hopital Nord AP-HM
    Marseille, 13015, France
  • Institut De Cancerologie De L'Ouest
    Saint-Herblain, 44115, France
  • Institute of Lung Diseases Vojvodina
    Kamenitz, Južnobanatski Okrug 21204, Serbia
  • Clinical Center of Serbia
    Belgrade, 11000, Serbia
  • Clinical Hospital Center Bezanijska Kosa
    Belgrade, 11070, Serbia
  • Chungbuk National University Hospital
    Cheongju-si, 28644, South Korea
  • Seoul National University Bundang Hospital
    Gyeonggi-do, 13620, South Korea
  • Seoul National University Hospital
    Seoul, 03080, South Korea
  • Kangbuk Samsung Hospital
    Seoul, 03181, South Korea
  • Severance Hospital, Yonsei University Health System
    Seoul, 03722, South Korea
  • Asan Medical Center
    Seoul, 05505, South Korea
  • Hospital Univ Germans Trias i Pujol
    Badalona, Barcelona 8916, Spain
  • Complejo Hospitalario Universitario Insular?Materno Infantil
    Las Palmas de Gran Canaria, LAS Palmas 35016, Spain
  • Hospital General Universitario de Alicante
    Alicante, 03010, Spain
  • Hospital Universitario Vall d'Hebron - PPDS
    Barcelona, 08035, Spain
  • Clinica Universitaria Navarra (Madrid)
    Madrid, 28036, Spain
  • Hospital Universitario 12 de Octubre
    Madrid, 28041, Spain
  • Hospital Universitario Puerta de Hierro - Majadahonda
    Madrid, 28222, Spain
  • Hospital Regional Universitario de Malaga ? Hospital General
    Málaga, 29010, Spain
  • Centro Medico Quironsalud Sagrado Corazon
    Seville, 41013, Spain
  • Hospital Universitario Virgen del Rocio
    Seville, 41013, Spain
  • Taipei Medical University ?Shuang Ho Hospital
    New Taipei City, 23561, Taiwan
  • National Cheng Kung University Hospital
    North Dist., 70403, Taiwan
  • National Taiwan University Hospital
    Taipei, 10002, Taiwan
  • Taipei Veterans General Hospital
    Taipei, 1121, Taiwan
  • Chang Gung Memorial Hospital - Linkou
    Taoyuan, 333, Taiwan
09

References and documents

Publications

  • Guan X, Hu R, Choi Y, Srivats S, Nabet BY, Silva J, McGinnis L, Hendricks R, Nutsch K, Banta KL, Duong E, Dunkle A, Chang PS, Han CJ, Mittman S, Molden N, Daggumati P, Connolly W, Johnson M, Abreu DR, Cho BC, Italiano A, Gil-Bazo I, Felip E, Mellman I, Mariathasan S, Shames DS, Meng R, Chiang EY, Johnston RJ, Patil NS. Anti-TIGIT antibody improves PD-L1 blockade through myeloid and Treg cells. Nature. 2024 Mar;627(8004):646-655. doi: 10.1038/s41586-024-07121-9. Epub 2024 Feb 28. PubMed 38418879 ↗
  • Cho BC, Abreu DR, Hussein M, Cobo M, Patel AJ, Secen N, Lee KH, Massuti B, Hiret S, Yang JCH, Barlesi F, Lee DH, Ares LP, Hsieh RW, Patil NS, Twomey P, Yang X, Meng R, Johnson ML. Tiragolumab plus atezolizumab versus placebo plus atezolizumab as a first-line treatment for PD-L1-selected non-small-cell lung cancer (CITYSCAPE): primary and follow-up analyses of a randomised, double-blind, phase 2 study. Lancet Oncol. 2022 Jun;23(6):781-792. doi: 10.1016/S1470-2045(22)00226-1. Epub 2022 May 13. PubMed 35576957 ↗

Study documents

  • Protocol and statistical analysis plan · Sep 25, 2023

Documents are hosted by the registry — open the source record to download them.

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 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03563716
Lead sponsor
Genentech, Inc.
Responsible party
Sponsor
First posted
Jun 20, 2018
Start date
Aug 10, 2018
Primary completion
Jun 30, 2019
Completion
Nov 14, 2025
Results posted
Jul 9, 2020
Last update
May 4, 2026

Study contacts

Clinical Trials
study director · Hoffmann-La Roche

Oversight

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

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