CClinicalTrials.gg
Sign In
Active, not recruitingNCT03178552B-FASTUpdated Sep 3, 2026

A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC)

A Phase 2/3 interventional study of Alectinib and Atezolizumab in Non-Small Cell Lung Cancer, sponsored by Hoffmann-La Roche. Active, not recruiting at 161 sites in 27 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.

Sponsored by Hoffmann-La Roche · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
1,000
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a phase 2/3, global, multicenter, open-label, multi-cohort study designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or in combination in participants with unresectable, advanced or metastatic NSCLC determined to harbor oncogenic somatic mutations or positive by tumor mutational burden (TMB) assay as identified by a blood-based next-generation sequencing (NGS) circulating tumor DNA (ctDNA) assay.

02

Conditions studied

  • Non-Small Cell Lung Cancer
03

Who can participate

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

Inclusion criteria

  • Histologically or cytologically confirmed diagnosis of unresectable Stage IIIb not amenable to treatment with combined modality chemoradiation (advanced) or Stage IV (metastatic) NSCLC
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
  • Measurable disease
  • Adequate recovery from most recent systemic or local treatment for cancer
  • Adequate organ function
  • Life expectancy greater than or equal to (>/=) 12 weeks
  • For female participants of childbearing potential and male participants, willingness to use acceptable methods of contraception

Exclusion criteria

Exclusion Criteria:

  • Inability to swallow oral medication
  • Women who are pregnant or lactating
  • Symptomatic, untreated CNS metastases
  • History of malignancy other than NSCLC within 5 years prior to screening with the exception of malignancies with negligible risk of metastasis or death
  • Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction, or cerebrovascular accident within 3 months prior to randomization, unstable arrhythmias, or unstable angina
  • Known active or uncontrolled human immunodeficiency virus (HIV) infection
  • Either a concurrent condition or history of a prior condition that places the patient at unacceptable risk if he/she were treated with the study drug or confounds the ability to interpret data from the study
  • Inability to comply with other requirements of the protocol
04

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,000 participants (estimated)

Study arms

  • Experimental
    Cohort A: Alectinib 600 Milligrams (mg)

    This cohort includes participants with anaplastic lymphoma kinase (ALK) positive NSCLC. Participants will receive alectinib 600 mg orally twice in a day (BID) until disease progression, unacceptable toxicity, withdrawal of consent or death. Enrollment to Cohort A is complete.

    Drug: Alectinib

  • Experimental
    Cohort B: Dose Finding Phase (DFP) Alectinib

    This cohort includes participants with rearranged during transfection (RET) positive NSCLC. Participants may receive alectinib 900 or 1200 mg orally BID until disease progression, unacceptable toxicity, withdrawal of consent or death if the recommended phase 2 dose (RP2D) is not established in any other clinical study. Participants may receive 750 mg or 600 mg, if it is unsafe to pursue the higher starting dose. Enrollment to Cohort B is complete.

    Drug: Alectinib

  • Experimental
    Cohort B: Dose Expansion Phase (DEP) Alectinib

    This cohort includes participants with RET positive NSCLC. Participants will receive alectinib at the RP2D established in the DFP of Cohort B or a separate clinical study. Participants will continue receiving study treatment until disease progression, unacceptable toxicity, withdrawal of consent or death. Enrollment to Cohort B is complete.

    Drug: Alectinib

  • Experimental
    Cohort C: Atezolizumab 1200 mg

    This cohort includes participants with bTMB positive NSCLC. Participants will receive atezolizumab at a dose of 1200 mg administered by IV infusion every 21 days (Q21D) until disease progression, loss of clinical benefit, unacceptable toxicity, withdrawal of consent or death. Enrollment to Cohort C is complete.

    Drug: Atezolizumab

  • Active comparator
    Cohort C: Pemetrexed, Cisplatin or Carboplatin

    This cohort includes participants with bTMB positive, non-squamous NSCLC. Participants will receive 4 or 6 cycles of treatment, with each cycle being 21 days in duration. Carboplatin at a dose of area under the concentration-time curve (AUC) of 5 or 6 IV or cisplatin at a dose of 75 milligrams per meter square (mg/m\^2) IV on Day 1 of each cycle combined with pemetrexed at a dose of 500 mg/m\^2 IV on Day 1 of each cycle. Pemetrexed may be continued as maintenance therapy every 21 days (Q21D) as per local standard of care. Enrollment to Cohort C is complete.

    Drug: Pemetrexed · Drug: Cisplatin · Drug: Carboplatin

  • Active comparator
    Cohort C: Gemcitabine, Cisplatin or Carboplatin

    This cohort includes participants with bTMB positive, squamous NSCLC. Participants will receive 4 or 6 cycles of treatment, with each cycle being 21 days in duration. Gemcitabine 1250 mg/m\^2 IV on Days 1 and 8 of every cycle and cisplatin 75 mg/m\^2 IV on Day 1 Q21D or gemcitabine 1000 mg/m\^2 IV on Days 1 and 8 of every cycle and carboplatin AUC 5 IV on Day 1 Q21D. Enrollment to Cohort C is complete.

    Drug: Cisplatin · Drug: Carboplatin · Drug: Gemcitabine

  • Experimental
    Cohort D: Entrectinib 600 Milligrams (mg)

    This cohort includes participants with c-ros oncogene 1 positive (ROS1+) NSCLC. Participants will receive entrectinib 600 mg orally once a day (QD) until disease progression, unacceptable toxicity, withdrawal of consent or death. Enrollment to Cohort D is complete.

    Drug: Entrectinib

  • Experimental
    Cohort E: Atezolizumab, Vemurafenib, and Cobimetinib

    This cohort includes participants with BRAF V600 mutation. Participants will receive: atezolizumab 1680 mg IV Q4W after the run-in period; cobimetinib 60 mg orally (PO) QD on Days 1-21 of each cycle during the run-in and triple-combination periods; and vemurafenib 960 mg PO twice daily (BID) on Days 1-21 of the initial run-in period, then 720 mg PO BID on Days 1-22 of the initial run-in period and on Days 1-28 of each cycle during the triple-combination period. Enrollment to Cohort E is complete.

    Drug: Atezolizumab · Drug: Cobimetinib · Drug: Vemurafenib

  • Experimental
    Cohort F: Atezolizumab, Bevacizumab, Carboplatin, and Pemetrexed

    This cohort includes participants with EGFR exon 20+ NSCLC. Participants will receive atezolizumab + bevacizumab + carboplatin + pemetrexed for 4 or 6 induction cycles (cycle = 21 days). After induction therapy, participants will continue maintenance treatment with atezolizumab + bevacizumab + pemetrexed until disease progression, unacceptable toxicity, withdrawal of consent, or death. Enrollment to Cohort F is complete.

    Drug: Atezolizumab · Drug: Pemetrexed · Drug: Carboplatin · Drug: Bevacizumab

  • Experimental
    Cohort G: Divarasib or Docetaxel

    Experimental: Cohort G: GDC-6036 or Docetaxel This cohort includes participants with KRAS G12C mutation. Participants will receive GDC-6036 PO QD or IV docetaxel Q3W (75 mg/m\^2) until disease progression or unacceptable toxicity New participants will no longer receive docetaxel.

    Drug: Divarasib · Drug: Docetaxel

  • No intervention
    Cohort Z: Natural History Cohort

    Participants with genomic profiles of interest that are not enrolled in the other cohorts will enter into natural history follow-up.

Interventions

  • DrugAlectinib

    Participants will receive 600 mg BID (Cohort A); 900, 1200, or 750 mg BID (Cohort B) or RP2D BID; orally until disease progression, unacceptable toxicity, withdrawal of consent or death.

    Also known as: RO5424802

  • DrugAtezolizumab

    Participants will receive atezolizumab 1200 mg IV infusion Q21D (Cohorts C and F) or 1680 mg IV infusion Q4W starting on Day 29 (Cohort E).

    Also known as: RO5541267

  • DrugPemetrexed

    Participants will receive pemetrexed 500 mg/m\^2 IV infusion on Day 1 Q21D.

  • DrugCisplatin

    Participants will receive cisplatin 75 mg/m\^2 IV on Day 1 Q21D.

  • DrugCarboplatin

    Participants will receive carboplatin of AUC 5 or 6 IV on Day 1 Q21D.

  • DrugGemcitabine

    Participants will receive gemcitabine 1000 or 1250 mg/m\^2 on Days 1 and 8 of every cycle (1 Cycle=21 days).

  • DrugEntrectinib

    Participants will receive entrectinib 600 mg orally QD.

    Also known as: RO7102122

  • DrugCobimetinib

    Participants will receive 60 mg PO QD on Days 1-21 of the initial run-in and triple-combination periods.

    Also known as: RO5514041

  • DrugVemurafenib

    Participants will receive 960 mg PO BID on Days 1-21 of the initial run-in period, and 720 mg PO BID on Days 22-28 of the initial run-in period and on Days 1-28 of each cycle during the triple-combination period.

    Also known as: RO5185426

  • DrugBevacizumab

    Participants will receive 15 mg/kg of IV bevacizumab on Day 1 of each 21-day cycle during the induction and maintenance periods.

    Also known as: RO4876646

  • DrugDivarasib

    Participants will receive divarasib PO QD until disease progression or unacceptable toxicity.

    Also known as: RO7435846; GDC-6036

  • DrugDocetaxel

    Participants will receive IV docetaxel Q3W (75 mg/m\^2) until disease progression or unacceptable toxicity

05

What researchers measure

Primary outcomes

  1. Cohort A: Percentage of Participants with Confirmed Objective Response as Assessed by the Investigator Based on the Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1

    Time frame: Baseline up to disease progression or death (up to approximately 6 years)

  2. Cohort B: Percentage of Participants with Confirmed Objective Response as Assessed by the Investigator Based on RECIST v1.1

    Time frame: Baseline up to disease progression or death (up to approximately 6 years)

  3. Cohort C: Progression Free Survival (PFS) as Assessed by the Investigator Based on RECIST v1.1 in bTMB PP1

    Time frame: Baseline up to disease progression or death (up to approximately 6 years)

  4. Cohort D: Percentage of Participants with Confirmed Objective Response as Assessed by the Investigator Based on RECIST v1.1

    Time frame: Baseline up to disease progression or death (up to approximately 6 years)

  5. Cohort E: Time in Response (TIR) as Assessed by the Investigator Based on RECIST v1.1

    Time frame: Month 12

  6. Cohort F: Investigator-Assessed Objective Response Rate (ORR) Based on RECIST v1.1

    Time frame: Baseline up to disease progression or death (up to approximately 6 years)

  7. Cohort G: Incidence of Adverse Events (AEs)

    Time frame: Baseline to last dose of study treatment + 30 days or until initiation of new anticancer therapy, whichever occurs first (up to approximately 6 years)

Secondary outcomes

  1. Cohorts A-F: Duration of Response (DOR) as Assessed by the Investigator Based on RECIST v1.1

    Time frame: Baseline up to disease progression or death (up to approximately 6 years)

  2. Cohorts A, B and D: Percentage of Participants with Clinical Benefit Response as Assessed by the Investigator Based on RECIST v1.1

    Time frame: Baseline up to disease progression or death (up to approximately 6 years)

  3. Cohorts A, B, D, F: PFS as Assessed by the Investigator Based on RECIST v1.1

    Time frame: Baseline up to disease progression or death (up to approximately 6 years)

  4. Cohorts A-F: Duration of Response as Assessed by the Independent Review Facility (IRF) Based on RECIST v1.1

    Time frame: Baseline up to disease progression or death (up to approximately 6 years)

  5. Cohorts A, B and D: Percentage of Participants with Clinical Benefit Response as Assessed by IRF Based on RECIST v1.1

    Time frame: Baseline up to disease progression or death (up to approximately 6 years)

  6. Cohorts A-F: PFS as Assessed by IRF Based on RECIST v1.1

    Time frame: Baseline up to disease progression or death (up to approximately 6 years)

  7. Cohorts A-F: Percentage of Participants with Confirmed Objective Response as Assessed by IRF Based on RECIST v1.1

    Time frame: Baseline up to disease progression or death (up to approximately 6 years)

  8. Cohorts A-F: Overall Survival (OS)

    Time frame: Baseline up to approximately 6 years

  9. Cohorts A-F: Percentage of Participants with Adverse Events (AEs)

    Time frame: Baseline up to approximately 6 years

  10. Cohorts A, B, D, E, F: Percentage of Participants with Improvement Compared with Baseline in Total Severity Symptom Score as Measured by Symptoms in Lung Cancer (SILC) Scale in Patient-Reported Lung Cancer Symptoms (Cough, Dyspnea and Chest Pain)

    Time frame: Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years

  11. Cohorts A-F: Time to Deterioration in Patient-Reported Lung Cancer Symptoms (Cough, Dyspnea and Chest Pain) as Measured by the SILC Scale

    Time frame: Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years

  12. Cohorts C, E, F: Change from Baseline in Patient-Reported Lung Cancer Symptom (Cough, Dyspnea, Chest pain) Score as Measured by the SILC Scale

    Time frame: Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years

  13. Cohorts A-F: Change from Baseline in Health Related Quality of Life (HRQoL) Scores as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - C30 (EORTC QLQ-C30)

    Time frame: Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years

  14. Cohorts A, B, D, E, F: Change from Baseline in HRQoL Scores as Measured by the SILC Scale

    Time frame: Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years

  15. Cohorts A-F: Change from Baseline in Patient Functioning and Symptoms Score as Measured by the EORTC QLQ-C30

    Time frame: Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years

  16. Cohorts A, B, D, E, F: Change from Baseline in Patient Functioning and Symptoms Score as Measured by the SILC Scale

    Time frame: Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years

  17. Cohorts A-F: Health Status Assessed as an Index Score Using the European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire

    Time frame: Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years

  18. Cohort B: Percentage of Participants with Dose-Limiting Toxicities (DLTs)

    Time frame: Day 1 to Day 28 of Cycle 1 (cycle length = 28 days)

  19. Cohort B: Maximum Plasma Concentration (Cmax) of Alectinib

    DFP: Dose-Finding Phase; DEP: Dose-Expanding Phase.

    Time frame: DFP: pre-dose (0 hours [hr]) on Day 1 of Cycle 2; 0.5, 1, 2, 4, 6, 8 and 10 hr post-dose on Day 1 of Cycle 2 (1 Cycle=28 days)

  20. Cohort B: Area Under the Concentration-Time Curve from Time Zero to the Last Measurable Concentration (AUC0-last) of Alectinib

    Time frame: DFP: pre-dose (0 hr) on Day 1 of Cycle 2; 0.5, 1, 2, 4, 6, 8 and 10 hr post-dose on Day 1 of Cycle 2 (1 Cycle=28 days)

  21. Cohort B: Time to Reach Cmax (Tmax) of Alectinib

    Time frame: DFP: pre-dose (0 hr) on Day 1 of Cycle 2; 0.5, 1, 2, 4, 6, 8 and 10 hr post-dose on Day 1 of Cycle 2 (1 Cycle=28 days)

  22. Cohort B: Half-Life (t1/2) of Alectinib

    Time frame: DFP: pre-dose (0 hr) on Day 1 of Cycle 2; 0.5, 1, 2, 4, 6, 8 and 10 hr post-dose on Day 1 of Cycle 2 (1 Cycle=28 days)

  23. Cohort B: Metabolite to Parent Exposure Ratio for AUC0-last

    Time frame: DFP: pre-dose (0 hr) on Day 1 of Cycle 2; 0.5, 1, 2, 4, 6, 8 and 10 hr post-dose on Day 1 of Cycle 2 (1 Cycle=28 days)

  24. Cohort B: Metabolite to Parent Exposure Ratio for Cmax

    Time frame: DFP: pre-dose (0 hr) on Day 1 of Cycle 2; 0.5, 1, 2, 4, 6, 8 and 10 hr post-dose on Day 1 of Cycle 2 (1 Cycle=28 days)

  25. Cohort C: Percentage of Participants with Objective Response as Assessed by the Investigator Based on RECIST v1.1

    Time frame: Baseline up to disease progression or death (up to approximately 6 years)

  26. Cohort C: Percentage of Participants Free from Disease Progression as Assessed by the Investigator Based on RECIST v1.1 at Months 6 and 12

    Time frame: Months 6, 12

  27. Cohort C: PFS as Assessed by the Investigator based on RECIST v1.1 in bTMB PP2

    Time frame: Baseline up to disease progression or death (up to approximately 6 years)

  28. Cohort C: OS in bTMB PP2

    Time frame: Baseline up to approximately 6 years

  29. Cohort D: Time to CNS progression as Assessed by the Investigator Based on RECIST v1.1

    Time frame: Baseline up to CNS progression (up to approximately 6 years)

  30. Cohort D: Time to CNS progression as Assessed by the IRF Based on RECIST v1.1

    Time frame: Baseline up to CNS progression (up to approximately 6 years)

  31. Cohort D: Percentage of Participants who have shown improvement compared with Baseline in patient-reported cognitive function, fatigue, HRQoL, headache and vision disorder per the EORTC QLQ-C30

    Time frame: Baseline, every 4 weeks until disease progression, up to approximately 6 years

  32. Cohort D: Percentage of Participants who have shown improvement compared with Baseline in patient-reported cognitive function, fatigue, HRQoL, headache and vision disorder per the EORTC QLQ-BN20

    Time frame: Baseline, every 4 weeks until disease progression, up to approximately 6 years

  33. Cohort D: Mean Plasma Concentration of Entrectinib

    Time frame: Pre-dose (0 hr), 1.5 and 4 hr post-dose on Day 1 of Cycles 1, 2, 3, 4 and 5; and pre-dose on Day 1 of each subsequent treatment cycle (1 cycle = 28 days).

  34. Cohort D: Mean Plasma Concentration of Entrectinib Metabolite M5

    Time frame: Pre-dose (0 hr), 1.5 and 4 hr post-dose on Day 1 of Cycles 1, 2, 3, 4 and 5; and pre-dose on Day 1 of each subsequent treatment cycle (1 cycle = 28 days).

  35. Cohort E: TIR as Assessed by the Investigator Based on RECIST v1.1

    Time frame: Month 9

  36. Cohort E: TIR as Assessed by IRF

    Time frame: Month 12

  37. Cohorts E, F: Serum Concentration of Atezolizumab

    Time frame: Pre-dose (0 hr), 1.5 and 4 hr post-dose on Day 1 of Cycles 1, 2, 3, 4 and 5; and pre-dose on Day 1 of each subsequent treatment cycle (1 cycle = 28 days)

  38. Cohorts E, F: Change from Baseline in Anti-Drug Antibodies (ADAs)

    Time frame: Baseline up to approximately 6 years

  39. Cohorts E, F: Time to Confirmed Deterioration (TTCD) in Participant-Reported Lung Cancer Symptoms of Cough, Dyspnea, and Chest Pain, as Measured by the Symptoms in Lung Cancer (SILC)

    Time frame: Baseline up to approximately 6 years

  40. Cohorts E, F: Proportion of Participants who Improve Compared with Baseline in Participant-Reported Lung Cancer Symptoms of Cough, Dyspnea, and Chest Pain, as Measured by the SILC

    Time frame: Baseline up to approximately 6 years

  41. Cohort G: Plasma Concentration of Divarasib

    Time frame: Baseline up to approximately 6 years

06

Study locations

161 sites
  • UC Davis
    Sacramento, California 95817, United States
  • Rocky Mountain Cancer Center
    Denver, Colorado 80218, United States
  • SCRI Florida Cancer Specialists South
    Fort Myers, Florida 33901, United States
  • Florida Cancer Specialist, North Region
    St. Petersburg, Florida 33705, United States
  • University of Kentucky
    Lexington, Kentucky 40536, United States
  • Comprehensive Cancer Centers of Nevada
    Las Vegas, Nevada 89128, United States
  • Dartmouth Hitchcock Medical Center
    Lebanon, New Hampshire 03756, United States
  • Weill Cornell Medical College-New York Presbyterian Hospital
    New York, New York 10021, United States
  • Montefiore Medical Center
    The Bronx, New York 10461, United States
  • Oregon HSU
    Portland, Oregon 97210, United States
  • St. Luke's University Health network
    Bethlehem, Pennsylvania 18015, United States
  • Sarah Cannon Research Institute / Tennessee Oncology
    Chattanooga, Tennessee 37404, United States
  • Fundación CENIT para la Investigación en Neurociencias
    Buenos Aires, C1125ABD, Argentina
  • Hospital Italiano
    Buenos Aires, C1181ACH, Argentina
  • Hospital Britanico de Buenos Aires
    Ciudad Autonoma Buenos Aires, C1284AEB, Argentina
  • Royal North Shore Hospital
    St Leonards, New South Wales 2065, Australia
  • The Prince Charles Hospital
    Chermside, Queensland 4032, Australia
  • Ashford Cancer Center Research
    Kurralta Park, South Australia 5037, Australia
  • UZ Brussel
    Brussels, 1090, Belgium
  • Cliniques Universitaires St-Luc
    Brussels, 1200, Belgium
  • UZ Leuven Gasthuisberg
    Leuven, 3000, Belgium
  • Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
    Ijuí, Rio Grande do Sul 98700-000, Brazil
  • Hospital Sao Lucas - PUCRS
    Porto Alegre, Rio Grande do Sul 90610-000, Brazil
  • Instituto do Cancer do Estado de Sao Paulo - ICESP
    São Paulo, São Paulo 01246-000, Brazil
  • Instituto Nacional de Cancer - INCa
    Rio de Janeiro, 20560-120, Brazil
  • Cross Cancer Institute
    Edmonton, Alberta T6G 1Z2, Canada
  • CancerCare Manitoba
    Winnipeg, Manitoba R3E 0V9, Canada
  • Royal Victoria Regional Health Centre
    Barrie, Ontario L4M 6M2, Canada
  • William Osler Health System Brampton Civic Hospital
    Brampton, Ontario L6R 3J7, Canada
  • London Health Sciences Centre · Victoria Hospital
    London, Ontario N6A 5W9, Canada
  • Lakeridge Health Center
    Oshawa, Ontario L1G 2B9, Canada
  • Sunnybrook Health Sciences Centre
    Toronto, Ontario M4N 3M5, Canada
  • Princess Margaret Cancer Center
    Toronto, Ontario M5G 1Z5, Canada
  • Jewish General Hospital
    Montreal, Quebec H3T 1E2, Canada
  • IUCPQ (Hôpital Laval)
    Québec, Quebec G1V 4G5, Canada
  • Saskatoon Cancer Centre
    Saskatoon, Saskatchewan SK S7N 4H4, Canada
  • Bradford Hill Centro de Investigaciones Clinicas
    Recoleta, 8420383, Chile
  • Beijing Cancer Hospital
    Beijing, 100142, China
  • Hunan Cancer Hospital
    Changsha, 410013, China
  • The second Xiangya hospital of central south university
    Changsha, 410100, China
  • Sichuan Cancer Hospital
    Chengdu, 610041, China
  • West China Hospital - Sichuan University
    Chengdu, 610047, China
  • The First Affiliated Hospital of Guangzhou Medical University Pharmacy
    Guangzhou, 510120, China
  • Zhejiang Cancer Hospital
    Hangzhou, 310022, China
  • Shandong Cancer Hospital
    Jinan, 250117, China
  • The Second Affiliated Hospital to Nanchang University
    Nanchang, 330006, China
  • Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
    Nanjing, 210008, China
  • Fudan Unviversity Shanghai Cancer Center
    Shanghai, 200032, China
  • First Affiliated Hospital of Medical College of Xi'an Jiaotong University
    Xi'an, 710061, China
  • Institut Bergonie CLCC Bordeaux
    Bordeaux, 33000, France
  • Centre Francois Baclesse
    Caen, 14076, France
  • Centre Oscar Lambret
    Lille, 59020, France
  • Centre Léon Bérard
    Lyon, 69373, France
  • Hopital Caremeau
    Nîmes, 30029, France
  • Hopital Robert Schuman
    Nouilly, 57645, France
  • Hôpital Européen Georges Pompidou
    Paris, 75908, France
  • Hopital Tenon
    Paris, 75970, France
  • CHU Poitiers
    Poitiers, 86021, France
  • Hopital Pontchaillou
    Rennes, 35033, France
  • CHU de Toulouse - Hôpital Larrey
    Toulouse, 31059, France
  • Klinikum Chemnitz gGmbH
    Chemnitz, 09116, Germany
  • Asklepios-Fachklinik Muenchen-Gauting
    Gauting, 82131, Germany
  • Thoraxklinik Heidelberg gGmbH
    Heidelberg, 69126, Germany
  • HSK Dr.-Horst-Schmidt-Kliniken Klinik für Innere Medizin III Onkologie Hämatologie und Palliativmed
    Wiesbaden, 65199, Germany
  • Queen Mary Hospital
    Hong Kong, Hong Kong
  • Prince of Wales Hosp
    Shatin, Hong Kong
  • Soroka Medical Center
    Beersheba, 8410101, Israel
  • Rambam Health Care Campus
    Haifa, 3109601, Israel
  • Meir Medical Center
    Kfar Saba, 4428164, Israel
  • Rabin MC
    Petah Tikva, 4941492, Israel
  • Chaim Sheba Medical Center
    Ramat Gan, 5262100, Israel
  • Sourasky / Ichilov Hospital; Dept. of Oncology
    Tel Aviv, 6423906, Israel
  • Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
    Naples, Campania 80131, Italy
  • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola
    Meldola, Emilia-Romagna 47014, Italy
  • Irccs Centro Di Riferimento Oncologico (CRO)
    Aviano, Friuli Venezia Giulia 33081, Italy
  • Azienda Ospedaliera San Camillo Forlanini
    Rome, Lazio 00151, Italy
  • Asst Papa Giovanni XXIII
    Bergamo, Lombardy 24128, Italy
  • ASST di Cremona - Azienda Socio Sanitaria Territoriale di Cremona
    Cremona, Lombardy 26100, Italy
  • Irccs Istituto Europeo di Oncologia (IEO)
    Milan, Lombardy 20141, Italy
  • Asst Di Monza
    Monza, Lombardy 20900, Italy
  • Azienda Sanitaria Ospedaliera S Luigi Gonzaga
    Orbassano (TO), Piedmont 10043, Italy
  • Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
    Bunkyō City, 113-8677, Japan
  • National Hospital Organization Kyushu Medical Center
    Fukuoka, 810-8563, Japan
  • National Hospital Organization Kyushu Cancer Center
    Fukuoka, 811-1395, Japan
  • Kyushu University Hospital
    Fukuoka, 812-8582, Japan
  • Hiroshima University Hospital
    Hiroshima, 734-8551, Japan
  • Kanazawa University Hospital
    Ishikawa, 920-8641, Japan
  • Kanagawa Cancer Center
    Kanagawa, 241-8515, Japan
  • University Hospital Kyoto Prefectural University of Medicine
    Kyoto, 602-8566, Japan
  • Shikoku Cancer Center
    Matsuyama, 791-0280, Japan
  • Tohoku University Hospital
    Miyagi, 980-8574, Japan
  • Sendai Kousei Hospital
    Miyagi, 981-0914, Japan
  • Niigata University Medical & Dental Hospital
    Niigata, 951-8520, Japan
  • Niigata Cancer Center Hospital
    Niigata, 951-8566, Japan
  • Kindai University Hospital
    Osaka, 589-8511, Japan
  • Saga University Hospital
    Saga, 849-8501, Japan
  • Shizuoka Cancer Center
    Shizuoka, 411-8777, Japan
  • Juntendo University Hospital
    Tokyo, 113-8431, Japan
  • The Cancer Institute Hospital of JFCR
    Tokyo, 135-8550, Japan
  • Kyorin University Hospital
    Tokyo, 181-8611, Japan

Showing the first 100 of 161 sites across 27 countries.

07

References and documents

Publications

  • Mayerhoefer ME, Kienzle A, Woo S, Vargas HA. Update on Liquid Biopsy. Radiology. 2025 Jun;315(3):e241030. doi: 10.1148/radiol.241030. PubMed 40525978 ↗
  • Peters S, Gadgeel SM, Mok T, Nadal E, Kilickap S, Swalduz A, Cadranel J, Sugawara S, Chiu CH, Yu CJ, Moskovitz M, Tanaka T, Nersesian R, Shagan SM, Maclennan M, Mathisen M, Bhagawati-Prasad V, Diarra C, Assaf ZJ, Archer V, Dziadziuszko R. Entrectinib in ROS1-positive advanced non-small cell lung cancer: the phase 2/3 BFAST trial. Nat Med. 2024 Jul;30(7):1923-1932. doi: 10.1038/s41591-024-03008-4. Epub 2024 Jun 19. PubMed 38898120 ↗
  • Wang HY, Ho CC, Lin YT, Liao WY, Chen CY, Shih JY, Yu CJ. Comprehensive Genomic Analysis of Patients With Non-Small-Cell Lung Cancer Using Blood-Based Circulating Tumor DNA Assay: Findings From the BFAST Database of a Single Center in Taiwan. JCO Precis Oncol. 2024 Jan;8:e2300314. doi: 10.1200/PO.23.00314. PubMed 38190582 ↗
  • Peters S, Dziadziuszko R, Morabito A, Felip E, Gadgeel SM, Cheema P, Cobo M, Andric Z, Barrios CH, Yamaguchi M, Dansin E, Danchaivijitr P, Johnson M, Novello S, Mathisen MS, Shagan SM, Schleifman E, Wang J, Yan M, Mocci S, Voong D, Fabrizio DA, Shames DS, Riehl T, Gandara DR, Mok T. Atezolizumab versus chemotherapy in advanced or metastatic NSCLC with high blood-based tumor mutational burden: primary analysis of BFAST cohort C randomized phase 3 trial. Nat Med. 2022 Sep;28(9):1831-1839. doi: 10.1038/s41591-022-01933-w. Epub 2022 Aug 22. PubMed 35995953 ↗

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

08

Registry details

Key details

Study ID
NCT03178552
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Jun 7, 2017
Start date
Sep 22, 2017
Primary completion
Jun 30, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Sep 3, 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 ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Carcinoma, Non-Small-Cell Lung→

Other studies from this sponsor

Hoffmann-La Roche

Start the discussion