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AzTrials

Non-Small Cell Lung CancerPhase 2/3B-FASTNCT03178552

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 study testing Alectinib, Atezolizumab and Pemetrexed in people with Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 161 sites in 27 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Alectinib, Atezolizumab and Pemetrexed
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,000 participants
Where
161 sitesin 27 countries
Study dates
22 Sep 2017to 30 Jun 2027
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

161 sites in 27 countries.

161 sites in 27 countries

Japan22 sites

  • Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

    Bunkyō City, 113-8677

  • National Hospital Organization Kyushu Medical Center

    Fukuoka, 810-8563

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 811-1395

  • Kyushu University Hospital

    Fukuoka, 812-8582

  • Hiroshima University Hospital

    Hiroshima, 734-8551

  • Kanazawa University Hospital

    Ishikawa, 920-8641

  • Kanagawa Cancer Center

    Kanagawa, 241-8515

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, 602-8566

  • Shikoku Cancer Center

    Matsuyama, 791-0280

  • Tohoku University Hospital

    Miyagi, 980-8574

  • Sendai Kousei Hospital

    Miyagi, 981-0914

  • Niigata University Medical & Dental Hospital

    Niigata, 951-8520

  • Niigata Cancer Center Hospital

    Niigata, 951-8566

  • Kindai University Hospital

    Osaka, 589-8511

  • Saga University Hospital

    Saga, 849-8501

  • Shizuoka Cancer Center

    Shizuoka, 411-8777

  • Juntendo University Hospital

    Tokyo, 113-8431

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135-8550

  • Kyorin University Hospital

    Tokyo, 181-8611

  • Fujita Health University Hospital

    Toyoake-shi, 470-1192

  • Wakayama Medical University Hospital

    Wakayama, 641-8510

  • National Hospital Organization Yamaguchi - Ube Medical Center

    Yamaguchi, 775-0241

Other trials in Japan

Spain16 sites

  • Hospital General Univ. de Alicante

    Alicante, 03010

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Clínic i Provincial

    Barcelona, 08036

  • ICO Badalona - Hospital Germans Trias i Pujol

    Barcelona, 08916

  • Insititut Catala D'Oncologia

    L'Hospitalet de Llobregat, Barcelona, 08908

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

  • Hospital Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Centro Integral Oncologico Clara Campal

    Madrid, 28050

  • Hospital Universitario Puerta de Hierro

    Madrid, 28222

  • Hospital Quiron de Madrid

    Madrid, 28223

  • Hospital Regional Universitario Carlos Haya

    Málaga, 29010

  • Clinica Universitaria de Navarra

    Pamplona, Navarre, 31008

  • Complejo Hospitalario Universitario de Santiago (CHUS)

    Santiago de Compostela, LA Coruna, 15706

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010

Other trials in Spain

United States12 sites

  • St. Luke's University Health network

    Bethlehem, Pennsylvania, 18015

  • Sarah Cannon Research Institute / Tennessee Oncology

    Chattanooga, Tennessee, 37404

  • Rocky Mountain Cancer Center

    Denver, Colorado, 80218

  • SCRI Florida Cancer Specialists South

    Fort Myers, Florida, 33901

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89128

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • University of Kentucky

    Lexington, Kentucky, 40536

  • Weill Cornell Medical College-New York Presbyterian Hospital

    New York, New York, 10021

  • Oregon HSU

    Portland, Oregon, 97210

  • UC Davis

    Sacramento, California, 95817

  • Florida Cancer Specialist, North Region

    St. Petersburg, Florida, 33705

  • Montefiore Medical Center

    The Bronx, New York, 10461

Other trials in United States

China12 sites

  • Beijing Cancer Hospital

    Beijing, 100142

  • Hunan Cancer Hospital

    Changsha, 410013

  • The second Xiangya hospital of central south university

    Changsha, 410100

  • Sichuan Cancer Hospital

    Chengdu, 610041

  • West China Hospital - Sichuan University

    Chengdu, 610047

  • The First Affiliated Hospital of Guangzhou Medical University Pharmacy

    Guangzhou, 510120

  • Zhejiang Cancer Hospital

    Hangzhou, 310022

  • Shandong Cancer Hospital

    Jinan, 250117

  • The Second Affiliated Hospital to Nanchang University

    Nanchang, 330006

  • Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School

    Nanjing, 210008

  • Fudan Unviversity Shanghai Cancer Center

    Shanghai, 200032

  • First Affiliated Hospital of Medical College of Xi'an Jiaotong University

    Xi'an, 710061

Other trials in China

Canada11 sites

  • Royal Victoria Regional Health Centre

    Barrie, Ontario, L4M 6M2

  • William Osler Health System Brampton Civic Hospital

    Brampton, Ontario, L6R 3J7

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • London Health Sciences Centre · Victoria Hospital

    London, Ontario, N6A 5W9

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • Lakeridge Health Center

    Oshawa, Ontario, L1G 2B9

  • IUCPQ (Hôpital Laval)

    Québec, Quebec, G1V 4G5

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, SK S7N 4H4

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Cancer Center

    Toronto, Ontario, M5G 1Z5

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

France11 sites

  • Institut Bergonie CLCC Bordeaux

    Bordeaux, 33000

  • Centre Francois Baclesse

    Caen, 14076

  • Centre Oscar Lambret

    Lille, 59020

  • Centre Léon Bérard

    Lyon, 69373

  • Hopital Caremeau

    Nîmes, 30029

  • Hopital Robert Schuman

    Nouilly, 57645

  • Hôpital Européen Georges Pompidou

    Paris, 75908

  • Hopital Tenon

    Paris, 75970

  • CHU Poitiers

    Poitiers, 86021

  • Hopital Pontchaillou

    Rennes, 35033

  • CHU de Toulouse - Hôpital Larrey

    Toulouse, 31059

Other trials in France

Italy9 sites

  • Irccs Centro Di Riferimento Oncologico (CRO)

    Aviano, Friuli Venezia Giulia, 33081

  • Asst Papa Giovanni XXIII

    Bergamo, Lombardy, 24128

  • ASST di Cremona - Azienda Socio Sanitaria Territoriale di Cremona

    Cremona, Lombardy, 26100

  • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola

    Meldola, Emilia-Romagna, 47014

  • Irccs Istituto Europeo di Oncologia (IEO)

    Milan, Lombardy, 20141

  • Asst Di Monza

    Monza, Lombardy, 20900

  • Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale

    Naples, Campania, 80131

  • Azienda Sanitaria Ospedaliera S Luigi Gonzaga

    Orbassano (TO), Piedmont, 10043

  • Azienda Ospedaliera San Camillo Forlanini

    Rome, Lazio, 00151

Other trials in Italy

Turkey (Türkiye)7 sites

  • Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology

    Adana, 01230

  • Akdeniz University Medical Faculty; Medical Oncology Department

    Antalya, 07070

  • Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department

    Edirne, 22770

  • Medipol University Medical Faculty; Oncology Department

    Istanbul, 34214

  • Marmara University Pendik Training and Research Hospital; Medikal Onkoloji

    Istanbul, 34890

  • Medikal Park Izmir Hospital

    Kar??yaka, 35575

  • Hacettepe Uni Medical Faculty Hospital; Oncology Dept

    Sihhiye/Ankara, 06230

Other trials in Turkey (Türkiye)

Israel6 sites

  • Soroka Medical Center

    Beersheba, 8410101

  • Rambam Health Care Campus

    Haifa, 3109601

  • Meir Medical Center

    Kfar Saba, 4428164

  • Rabin MC

    Petah Tikva, 4941492

  • Chaim Sheba Medical Center

    Ramat Gan, 5262100

  • Sourasky / Ichilov Hospital; Dept. of Oncology

    Tel Aviv, 6423906

Other trials in Israel

South Korea5 sites

  • National Cancer Center

    Gyeonggi-do, 10408

  • Chonnam National University Hwasun Hospital

    Jeollanam-do, 58128

  • Seoul National University Hospital

    Seoul, 03080

  • Asan Medical Center

    Seoul, 05505

  • Yonsei University Health System/Severance Hospital

    Seoul, 120-752

Other trials in South Korea

Brazil4 sites

  • Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda

    Ijuí, Rio Grande do Sul, 98700-000

  • Hospital Sao Lucas - PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Instituto Nacional de Cancer - INCa

    Rio de Janeiro, 20560-120

  • Instituto do Cancer do Estado de Sao Paulo - ICESP

    São Paulo, São Paulo, 01246-000

Other trials in Brazil

Germany4 sites

  • Klinikum Chemnitz gGmbH

    Chemnitz, 09116

  • Asklepios-Fachklinik Muenchen-Gauting

    Gauting, 82131

  • Thoraxklinik Heidelberg gGmbH

    Heidelberg, 69126

  • HSK Dr.-Horst-Schmidt-Kliniken Klinik für Innere Medizin III Onkologie Hämatologie und Palliativmed

    Wiesbaden, 65199

Other trials in Germany

Mexico4 sites

  • Health Pharma Professional Research

    Mexico City, Mexico CITY (federal District), 03100

  • AVIX Investigación Clínica S.C

    Monterrey, Nuevo León, 64710

  • Oncologico Potosino

    San Luis Potosí City, San Luis Potosí, 78250

  • Hospital Angeles Tijuana

    Tijuana, Estado de Baja California, 22010

Other trials in Mexico

Peru4 sites

  • Hospital Nacional Edgardo Rebagliati Martins

    Lima, 11

  • Instituto Nacional de Enfermedades Neoplasicas

    Lima, 15038

  • Instituto Peruano de Oncología y Radioterapia

    Lima

  • Clinica Ricardo Palma

    San Isidro, Lima 27

Other trials in Peru

Poland4 sites

  • Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

    Gda?sk, 80-214

  • Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie

    Olsztyn, 10-357

  • Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu

    Poznan, 60-569

  • Centrum Onkologii Instytut im.Marii Sklodowskiej-Curie

    Warsaw, 02-781

Other trials in Poland

Russia4 sites

  • Moscow City Oncology Hospital #62

    Moscovskaya Oblast, Moscow Oblast, 143423

  • Principal Military Clinical Hospital n.a. N.N. Burdenko

    Moscow, Moscow Oblast, 105229

  • Clinical Oncology Dispensary

    Omsk, 644013

  • S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)

    Saint Petersburg, Sankt-Peterburg, 197758

Other trials in Russia

Serbia4 sites

  • Clinical Center of Serbia

    Belgrade, 11000

  • University Hospital Medical Center Bezanijska kosa

    Belgrade, 11080

  • Institute for Pulmonary Diseases of Vojvodina

    Kamenitz, 21204

  • Clinical Center Nis

    Niš, 18000

Other trials in Serbia

Taiwan4 sites

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 83301

  • National Taiwan Uni Hospital

    Taipei, 100

  • Taipei Veterans General Hospital

    Taipei, 112

  • Chang Gung Medical Foundation - Linkou

    Taoyuan, 333

Other trials in Taiwan

Argentina3 sites

  • Fundación CENIT para la Investigación en Neurociencias

    Buenos Aires, C1125ABD

  • Hospital Italiano

    Buenos Aires, C1181ACH

  • Hospital Britanico de Buenos Aires

    Ciudad Autonoma Buenos Aires, C1284AEB

Other trials in Argentina

Australia3 sites

  • The Prince Charles Hospital

    Chermside, Queensland, 4032

  • Ashford Cancer Center Research

    Kurralta Park, South Australia, 5037

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

Other trials in Australia

Belgium3 sites

  • UZ Brussel

    Brussels, 1090

  • Cliniques Universitaires St-Luc

    Brussels, 1200

  • UZ Leuven Gasthuisberg

    Leuven, 3000

Other trials in Belgium

Hong Kong2 sites

  • Queen Mary Hospital

    Hong Kong

  • Prince of Wales Hosp

    Shatin

Other trials in Hong Kong

Singapore2 sites

  • National University Hospital

    Singapore, 119228

  • National Cancer Centre

    Singapore, 169610

Other trials in Singapore

Thailand2 sites

  • Faculty of Med. Siriraj Hosp.

    Bangkok, 10700

  • Prince of Songkla University

    Hat Yai, 90110

Other trials in Thailand

Chile1 site

  • Bradford Hill Centro de Investigaciones Clinicas

    Recoleta, 8420383

Other trials in Chile

New Zealand1 site

  • Auckland City Hospital

    Auckland, 1023

Other trials in New Zealand

Panama1 site

  • Hemato Oncología de Panamá Especializada

    Panama City, 0801

Other trials in Panama

About this study

Official title: 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.

Being tested
Alectinib, Atezolizumab, Pemetrexed, Cisplatin, Carboplatin
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AlectinibDrug

    Also called RO5424802

    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.

  • AtezolizumabDrug

    Also called RO5541267

    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).

  • PemetrexedDrug

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

  • CisplatinDrug

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

  • CarboplatinDrug

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

  • GemcitabineDrug

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

  • EntrectinibDrug

    Also called RO7102122

    Participants will receive entrectinib 600 mg orally QD.

  • CobimetinibDrug

    Also called RO5514041

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

  • VemurafenibDrug

    Also called RO5185426

    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.

  • BevacizumabDrug

    Also called RO4876646

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

  • DivarasibDrug

    Also called RO7435846; GDC-6036

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

  • DocetaxelDrug

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

Study groups in NCT03178552
Study groupRoleWhat they receive
Cohort A: Alectinib 600 Milligrams (mg)ExperimentalThis 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.
Receives: Drug: Alectinib
Cohort B: Dose Finding Phase (DFP) AlectinibExperimentalThis 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.
Receives: Drug: Alectinib
Cohort B: Dose Expansion Phase (DEP) AlectinibExperimentalThis 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.
Receives: Drug: Alectinib
Cohort C: Atezolizumab 1200 mgExperimentalThis 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.
Receives: Drug: Atezolizumab
Cohort C: Pemetrexed, Cisplatin or CarboplatinActive comparatorThis 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.
Receives: Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin
Cohort C: Gemcitabine, Cisplatin or CarboplatinActive comparatorThis 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.
Receives: Drug: Cisplatin; Drug: Carboplatin; Drug: Gemcitabine
Cohort D: Entrectinib 600 Milligrams (mg)ExperimentalThis 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.
Receives: Drug: Entrectinib
Cohort E: Atezolizumab, Vemurafenib, and CobimetinibExperimentalThis 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.
Receives: Drug: Atezolizumab; Drug: Cobimetinib; Drug: Vemurafenib
Cohort F: Atezolizumab, Bevacizumab, Carboplatin, and PemetrexedExperimentalThis 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.
Receives: Drug: Atezolizumab; Drug: Pemetrexed; Drug: Carboplatin; Drug: Bevacizumab
Cohort G: Divarasib or DocetaxelExperimentalExperimental: 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.
Receives: Drug: Divarasib; Drug: Docetaxel
Cohort Z: Natural History CohortNo interventionParticipants with genomic profiles of interest that are not enrolled in the other cohorts will enter into natural history follow-up.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Month 12

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

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

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

    Measured: 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 (41)

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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

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

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

    Measured: Baseline up to approximately 6 years

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

    Measured: 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)

    Measured: 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

    Measured: 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

    Measured: 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)

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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)

    Measured: 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.

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Months 6, 12

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

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

  28. Cohort C: OS in bTMB PP2

    Measured: Baseline up to approximately 6 years

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

    Measured: 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

    Measured: 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

    Measured: 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

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

  33. Cohort D: Mean Plasma Concentration of Entrectinib

    Measured: 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

    Measured: 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

    Measured: Month 9

  36. Cohort E: TIR as Assessed by IRF

    Measured: Month 12

  37. Cohorts E, F: Serum Concentration of Atezolizumab

    Measured: 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)

    Measured: 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)

    Measured: 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

    Measured: Baseline up to approximately 6 years

  41. Cohort G: Plasma Concentration of Divarasib

    Measured: Baseline up to approximately 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2017
  2. Study start22 Sep 2017
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03178552
Sponsor's protocol ID
BO29554
Other IDs
2017-000076-28, 2017
Acronym
B-FAST
Status last verified
Sep 2026
First submitted
5 Jun 2017
Last updated
3 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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

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

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Alectinib, Atezolizumab and Pemetrexed in people with Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 161 sites in 27 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 161 sites in Japan, Spain, United States, China, Canada and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03178552, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.

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