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

March 6, 2026 updated by: Hoffmann-La Roche

A Phase II/III Multicenter Study Evaluating the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Harboring Actionable Somatic Mutations Detected in Blood (B-FAST: Blood-First Assay Screening Trial)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1125ABD
        • Fundación Cenit para la Investigación en Neurociencias
      • Buenos Aires, Argentina, C1181ACH
        • Hospital Italiano
      • Ciudad Autonoma Buenos Aires, Argentina, C1284AEB
        • Hospital Británico de Buenos Aires
  • Australia
    • New South Wales
      • St Leonards, New South Wales, Australia, 2065
        • Royal North Shore Hospital
    • Queensland
      • Chermside, Queensland, Australia, 4032
        • The Prince Charles Hospital
    • South Australia
      • Kurralta Park, South Australia, Australia, 5037
        • Ashford Cancer Center Research
  • Belgium
      • Brussels, Belgium, 1090
        • Uz Brussel
      • Brussels, Belgium, 1200
        • Cliniques Universitaires St-Luc
      • Leuven, Belgium, 3000
        • UZ Leuven Gasthuisberg
  • Brazil
      • Rio de Janeiro, Brazil, 20560-120
        • Instituto Nacional de Câncer - INCA
    • Rio Grande do Sul
      • Ijuí, Rio Grande do Sul, Brazil, 98700-000
        • ONCOSITE - Centro de Pesquisa Clinica em Oncologia LTDA
      • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
        • Hospital Sao Lucas - PUCRS
    • São Paulo
      • São Paulo, São Paulo, Brazil, 01246-000
        • Instituto do Cancer do Estado de Sao Paulo - ICESP
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • CancerCare Manitoba
    • Ontario
      • Barrie, Ontario, Canada, L4M 6M2
        • Royal Victoria Regional Health Centre
      • Brampton, Ontario, Canada, L6R 3J7
        • William Osler Health System Brampton Civic Hospital
      • London, Ontario, Canada, N6A 5W9
        • London Health Sciences Centre · Victoria Hospital
      • Oshawa, Ontario, Canada, L1G 2B9
        • Lakeridge Health Center
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre
      • Toronto, Ontario, Canada, M5G 1Z5
        • Princess Margaret Cancer Center
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Jewish General Hospital
      • Québec, Quebec, Canada, G1V 4G5
        • IUCPQ (Hôpital Laval)
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, SK S7N 4H4
        • Saskatoon Cancer Centre
  • Chile
      • Recoleta, Chile, 8420383
        • Bradford Hill Centro de Investigaciones Clinicas
  • China
      • Beijing, China, 100142
        • Beijing Cancer Hospital
      • Changchun, China, 132013
        • Jilin Cancer Hospital
      • Changsha, China, 410013
        • Hunan Cancer Hospital
      • Changsha, China, 410100
        • The Second Xiangya Hospital Of Central South University
      • Chengdu, China, 610041
        • Sichuan Cancer Hospital
      • Chengdu, China, 610047
        • West China Hospital - Sichuan University
      • Guangzhou, China, 510120
        • The First Affiliated Hospital of Guangzhou Medical University Pharmacy
      • Hangzhou, China, 310022
        • Zhejiang Cancer Hospital
      • Jinan, China, 250117
        • Shandong Cancer Hospital
      • Nanchang, China, 330006
        • The Second Affiliated Hospital to Nanchang University
      • Nanjing, China, 210008
        • Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
      • Shanghai, China, 200032
        • Fudan Unviversity Shanghai Cancer Center
      • Xi'an, China, 710061
        • First Affiliated Hospital of Medical College of Xi'an Jiaotong University
  • France
      • Bordeaux, France, 33000
        • Institut Bergonie CLCC Bordeaux
      • Caen, France, 14076
        • Centre Francois Baclesse
      • Lille, France, 59020
        • Centre Oscar Lambret
      • Lyon, France, 69373
        • Centre Leon Berard
      • Nouilly, France, 57645
        • Hopital Robert Schuman
      • Nîmes, France, 30029
        • Hopital Caremeau
      • Paris, France, 75970
        • Hôpital Tenon
      • Paris, France, 75908
        • Hôpital Europeen Georges Pompidou
      • Poitiers, France, 86021
        • CHU Poitiers
      • Rennes, France, 35033
        • Hôpital Pontchaillou
      • Toulouse, France, 31059
        • CHU de Toulouse - Hopital Larrey
  • Germany
      • Chemnitz, Germany, 09116
        • Klinikum Chemnitz Ggmbh
      • Gauting, Germany, 82131
        • Asklepios-Fachklinik Muenchen-Gauting
      • Heidelberg, Germany, 69126
        • Thoraxklinik Heidelberg gGmbH
      • Wiesbaden, Germany, 65199
        • HSK Dr.-Horst-Schmidt-Kliniken Klinik für Innere Medizin III Onkologie Hämatologie und Palliativmed
  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
      • Shatin, Hong Kong
        • Prince of Wales Hosp
  • Israel
      • Beersheba, Israel, 8410101
        • Soroka Medical Center
      • Haifa, Israel, 3109601
        • Rambam Health Care Campus
      • Kfar Saba, Israel, 4428164
        • Meir Medical Center
      • Petah Tikva, Israel, 4941492
        • Rabin MC
      • Ramat Gan, Israel, 5262100
        • Chaim Sheba Medical Center
      • Tel Aviv, Israel, 6423906
        • Sourasky / Ichilov Hospital; Dept. of Oncology
  • Italy
    • Campania
      • Napoli, Campania, Italy, 80131
        • Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
    • Emilia-Romagna
      • Meldola, Emilia-Romagna, Italy, 47014
        • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola
    • Friuli Venezia Giulia
      • Aviano, Friuli Venezia Giulia, Italy, 33081
        • Irccs Centro Di Riferimento Oncologico (CRO)
    • Lazio
      • Rome, Lazio, Italy, 00151
        • Azienda Ospedaliera San Camillo Forlanini
    • Lombardy
      • Bergamo, Lombardy, Italy, 24128
        • Asst Papa Giovanni Xxiii
      • Cremona, Lombardy, Italy, 26100
        • ASST di Cremona - Azienda Socio Sanitaria Territoriale di Cremona
      • Milan, Lombardy, Italy, 20141
        • Irccs Istituto Europeo Di Oncologia (IEO)
      • Monza, Lombardy, Italy, 20900
        • Asst Di Monza
    • Piedmont
      • Orbassano (TO), Piedmont, Italy, 10043
        • Azienda Sanitaria Ospedaliera S Luigi Gonzaga
  • Japan
      • Bunkyō City, Japan, 113-8677
        • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
      • Fukuoka, Japan, 810-8563
        • National Hospital Organization Kyushu Medical Center
      • Fukuoka, Japan, 811-1395
        • National Hospital Organization Kyushu Cancer Center
      • Fukuoka, Japan, 812-8582
        • Kyushu University Hospital
      • Hiroshima, Japan, 734-8551
        • Hiroshima University Hospital
      • Ishikawa, Japan, 920-8641
        • Kanazawa University Hospital
      • Kanagawa, Japan, 241-8515
        • Kanagawa Cancer Center
      • Kyoto, Japan, 602-8566
        • University Hospital Kyoto Prefectural University of Medicine
      • Matsuyama, Japan, 791-0280
        • Shikoku Cancer Center
      • Miyagi, Japan, 980-8574
        • Tohoku University Hospital
      • Miyagi, Japan, 981-0914
        • Sendai Kousei Hospital
      • Niigata, Japan, 951-8520
        • Niigata University Medical & Dental Hospital
      • Niigata, Japan, 951-8566
        • Niigata Cancer Center Hospital
      • Osaka, Japan, 589-8511
        • Kindai University Hospital
      • Saga, Japan, 849-8501
        • Saga University Hospital
      • Shizuoka, Japan, 411-8777
        • Shizuoka Cancer Center
      • Tokyo, Japan, 135-8550
        • The Cancer Institute Hospital Of JFCR
      • Tokyo, Japan, 113-8431
        • Juntendo University Hospital
      • Tokyo, Japan, 181-8611
        • Kyorin University Hospital
      • Toyoake-shi, Japan, 470-1192
        • Fujita Health University Hospital
      • Wakayama, Japan, 641-8510
        • Wakayama Medical University Hospital
      • Yamaguchi, Japan, 775-0241
        • National Hospital Organization Yamaguchi - Ube Medical Center
  • Mexico
    • Estado de Baja California
      • Tijuana, Estado de Baja California, Mexico, 22010
        • Hospital Angeles Tijuana
    • Mexico CITY (federal District)
      • Mexico City, Mexico CITY (federal District), Mexico, 03100
        • Health Pharma Professional Research
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64710
        • AVIX Investigación Clínica S.C
    • San Luis Potosí
      • San Luis Potosí City, San Luis Potosí, Mexico, 78250
        • Oncológico Potosino
  • New Zealand
      • Auckland, New Zealand, 1023
        • Auckland City Hospital
  • Panama
      • Panama City, Panama, 0801
        • Hemato Oncología de Panamá Especializada
  • Peru
      • Lima, Peru, 11
        • Hospital Nacional Edgardo Rebagliati Martins
      • Lima, Peru, 15038
        • Instituto Nacional de Enfermedades Neoplasicas
      • Lima, Peru
        • Instituto Peruano de Oncologia y Radioterapia
      • San Isidro, Peru, Lima 27
        • Clinica Ricardo Palma
  • Poland
      • Gda?sk, Poland, 80-214
        • Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
      • Krakow, Poland, 31-202
        • Krakowski Szpital Specjalistyczny im sw.Jana Pawla II
      • Olsztyn, Poland, 10-357
        • Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie
      • Otwock, Poland, 05-400
        • Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy
      • Poznan, Poland, 60-569
        • Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
      • Warsaw, Poland, 02-781
        • Centrum Onkologii Instytut im.Marii Sklodowskiej-Curie
  • Russia
      • Omsk, Russia, 644013
        • Clinical Oncology Dispensary
    • Moscow Oblast
      • Moscovskaya Oblast, Moscow Oblast, Russia, 143423
        • Moscow City Oncology Hospital #62
      • Moscow, Moscow Oblast, Russia, 105229
        • Principal Military Clinical Hospital n.a. N.N. Burdenko
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Russia, 197758
        • S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)
  • Serbia
      • Belgrade, Serbia, 11000
        • Clinical Center of Serbia
      • Belgrade, Serbia, 11080
        • University Hospital Medical Center Bezanijska kosa
      • Kamenitz, Serbia, 21204
        • Institute for pulmonary diseases of Vojvodina
      • Niš, Serbia, 18000
        • Clinical Center Nis
  • Singapore
      • Singapore, Singapore, 169610
        • National Cancer Centre
      • Singapore, Singapore, 119228
        • National University Hospital
  • South Korea
      • Gyeonggi-do, South Korea, 10408
        • National Cancer Center
      • Jeollanam-do, South Korea, 58128
        • Chonnam National University Hwasun Hospital
      • Seoul, South Korea, 03080
        • Seoul National University Hospital
      • Seoul, South Korea, 05505
        • Asan Medical Center
      • Seoul, South Korea, 120-752
        • Yonsei University Health System/Severance Hospital
  • Spain
      • Alicante, Spain, 03010
        • Hospital General Univ. de Alicante
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebrón
      • Barcelona, Spain, 08036
        • Hospital Clinic I Provincial
      • Barcelona, Spain, 08916
        • ICO Badalona - Hospital Germans Trias I Pujol
      • Madrid, Spain, 28041
        • Hospital Universitario 12 De Octubre
      • Madrid, Spain, 28034
        • Hospital Ramon y Cajal
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañón
      • Madrid, Spain, 28050
        • Centro Integral Oncologico Clara Campal
      • Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro
      • Madrid, Spain, 28223
        • Hospital Quiron de Madrid
      • Málaga, Spain, 29010
        • Hospital Regional Universitario Carlos Haya
      • Seville, Spain, 41013
        • Hospital Universitario Virgen del Rocio
      • Valencia, Spain, 46010
        • Hospital Clinico Universitario de Valencia
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08908
        • Insititut Catala D'Oncologia
    • LA Coruna
      • Santiago de Compostela, LA Coruna, Spain, 15706
        • Complejo Hospitalario Universitario de Santiago (CHUS)
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Clinica Universitaria de Navarra
  • Taiwan
      • Kaohsiung City, Taiwan, 83301
        • Kaohsiung Chang Gung Memorial Hospital
      • Taipei, Taiwan, 112
        • Taipei Veterans General Hospital
      • Taipei, Taiwan, 100
        • National Taiwan Uni Hospital
      • Taoyuan District, Taiwan, 333
        • Chang Gung Medical Foundation - Linkou
  • Thailand
      • Bangkok, Thailand, 10700
        • Faculty of Med. Siriraj Hosp.
      • Hat Yai, Thailand, 90110
        • Prince of Songkla University
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 01230
        • Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
      • Antalya, Turkey (Türkiye), 07070
        • Akdeniz University Medical Faculty; Medical Oncology Department
      • Edirne, Turkey (Türkiye), 22770
        • Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department
      • Istanbul, Turkey (Türkiye), 34214
        • Medipol University Medical Faculty; Oncology Department
      • Istanbul, Turkey (Türkiye), 34890
        • Marmara University Pendik Training and Research Hospital; Medikal Onkoloji
      • Kar??yaka, Turkey (Türkiye), 35575
        • Medikal Park Izmir Hospital
      • Sihhiye/Ankara, Turkey (Türkiye), 06230
        • Hacettepe Uni Medical Faculty Hospital; Oncology Dept
  • United States
    • California
      • Sacramento, California, United States, 95817
        • UC Davis
    • Colorado
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Center
    • Florida
      • Fort Myers, Florida, United States, 33901
        • SCRI Florida Cancer Specialists South
      • St. Petersburg, Florida, United States, 33705
        • Florida Cancer Specialist, North Region
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Comprehensive Cancer Centers of Nevada
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center
    • New York
      • New York, New York, United States, 10021
        • Weill Cornell Medical College-New York Presbyterian Hospital
      • The Bronx, New York, United States, 10461
        • Montefiore Medical Center
    • Oregon
      • Portland, Oregon, United States, 97210
        • Oregon HSU
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • St. Luke's University Health Network
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Sarah Cannon Research Institute / Tennessee Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.
Other Names:
  • RO5424802
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
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.
Other Names:
  • RO5424802
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
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.
Other Names:
  • RO5424802
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
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).
Other Names:
  • RO5541267
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
Participants will receive pemetrexed 500 mg/m^2 IV infusion on Day 1 Q21D.
Drug: Cisplatin
Participants will receive cisplatin 75 mg/m^2 IV on Day 1 Q21D.
Drug: Carboplatin
Participants will receive carboplatin of AUC 5 or 6 IV on Day 1 Q21D.
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
Participants will receive cisplatin 75 mg/m^2 IV on Day 1 Q21D.
Drug: Carboplatin
Participants will receive carboplatin of AUC 5 or 6 IV on Day 1 Q21D.
Drug: Gemcitabine
Participants will receive gemcitabine 1000 or 1250 mg/m^2 on Days 1 and 8 of every cycle (1 Cycle=21 days).
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
Participants will receive entrectinib 600 mg orally QD.
Other Names:
  • RO7102122
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
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).
Other Names:
  • RO5541267
Drug: Cobimetinib
Participants will receive 60 mg PO QD on Days 1-21 of the initial run-in and triple-combination periods.
Other Names:
  • RO5514041
Drug: Vemurafenib
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.
Other Names:
  • RO5185426
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
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).
Other Names:
  • RO5541267
Drug: Pemetrexed
Participants will receive pemetrexed 500 mg/m^2 IV infusion on Day 1 Q21D.
Drug: Carboplatin
Participants will receive carboplatin of AUC 5 or 6 IV on Day 1 Q21D.
Drug: Bevacizumab
Participants will receive 15 mg/kg of IV bevacizumab on Day 1 of each 21-day cycle during the induction and maintenance periods.
Other Names:
  • RO4876646
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: Docetaxel
Participants will receive IV docetaxel Q3W (75 mg/m^2) until disease progression or unacceptable toxicity
Drug: Divarasib
Participants will receive divarasib PO QD until disease progression or unacceptable toxicity.
Other Names:
  • RO7435846; GDC-6036
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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)
Baseline up to disease progression or death (up to approximately 6 years)
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)
Baseline up to disease progression or death (up to approximately 6 years)
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)
Baseline up to disease progression or death (up to approximately 6 years)
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)
Baseline up to disease progression or death (up to approximately 6 years)
Cohort E: Time in Response (TIR) as Assessed by the Investigator Based on RECIST v1.1
Time Frame: Month 12
Month 12
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)
Baseline up to disease progression or death (up to approximately 6 years)
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)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
Baseline up to disease progression or death (up to approximately 6 years)
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)
Baseline up to disease progression or death (up to approximately 6 years)
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)
Baseline up to disease progression or death (up to approximately 6 years)
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)
Baseline up to disease progression or death (up to approximately 6 years)
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)
Baseline up to disease progression or death (up to approximately 6 years)
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
Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years
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
Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years
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
Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years
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
Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years
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
Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years
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
Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years
Cohort B: Percentage of Participants with Dose-Limiting Toxicities (DLTs)
Time Frame: Day 1 to Day 28 of Cycle 1 (cycle length = 28 days)
Day 1 to Day 28 of Cycle 1 (cycle length = 28 days)
Cohort B: Maximum Plasma Concentration (Cmax) of Alectinib
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)
DFP: Dose-Finding Phase; DEP: Dose-Expanding Phase.
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Baseline up to disease progression or death (up to approximately 6 years)
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
Months 6, 12
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)
Baseline up to disease progression or death (up to approximately 6 years)
Cohort C: OS in bTMB PP2
Time Frame: Baseline up to approximately 6 years
Baseline up to approximately 6 years
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)
Baseline up to CNS progression (up to approximately 6 years)
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)
Baseline up to CNS progression (up to approximately 6 years)
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
Baseline, every 4 weeks until disease progression, up to approximately 6 years
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
Baseline, every 4 weeks until disease progression, up to approximately 6 years
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).
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).
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).
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).
Cohort E: TIR as Assessed by the Investigator Based on RECIST v1.1
Time Frame: Month 9
Month 9
Cohort E: TIR as Assessed by IRF
Time Frame: Month 12
Month 12
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)
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)
Cohorts E, F: Change from Baseline in Anti-Drug Antibodies (ADAs)
Time Frame: Baseline up to approximately 6 years
Baseline up to approximately 6 years
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
Baseline up to approximately 6 years
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
Baseline up to approximately 6 years
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)
Baseline up to disease progression or death (up to approximately 6 years)
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)
Baseline up to disease progression or death (up to approximately 6 years)
Cohorts A-F: Overall Survival (OS)
Time Frame: Baseline up to approximately 6 years
Baseline up to approximately 6 years
Cohorts A-F: Percentage of Participants with Adverse Events (AEs)
Time Frame: Baseline up to approximately 6 years
Baseline up to approximately 6 years
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
Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years
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
Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years
Cohort G: Plasma Concentration of Divarasib
Time Frame: Baseline up to approximately 6 years
Baseline up to approximately 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 22, 2017

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 5, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 7, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BO29554
  • 2017-000076-28 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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