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

Non-Small Cell Lung Cancer Clinical Trial

— B-FAST  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03178552
• Other study ID #: BO29554
• Secondary ID: 2017-000076-28
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: September 22, 2017
• Est. completion date: August 3, 2028

Study information

• Verified date: April 2024
• Source: Hoffmann-La Roche
• Contact: Reference Study ID Number: BO29554 https://forpatients.roche.com
• Phone: 888-662-6728 (U.S. and Canada)
• Email: global-roche-genentech-trials[@]gene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 tumor mutational burden (TMB) assay as identified by two blood-based next-generation sequencing (NGS) circulating tumor DNA (ctDNA) assays.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: August 3, 2028
• Est. primary completion date: August 3, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 human immunodeficiency virus (HIV) positivity or autoimmune deficiency syndrome (AIDS)-related illness
• 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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

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.
• 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).
• Pemetrexed
Participants will receive pemetrexed 500 mg/m^2 IV infusion on Day 1 Q21D.
• Cisplatin
Participants will receive cisplatin 75 mg/m^2 IV on Day 1 Q21D.
• Carboplatin
Participants will receive carboplatin of AUC 5 or 6 IV on Day 1 Q21D.
• Gemcitabine
Participants will receive gemcitabine 1000 or 1250 mg/m^2 on Days 1 and 8 of every cycle (1 Cycle=21 days).
• Entrectinib
Participants will receive entrectinib 600 mg orally QD.
• Cobimetinib
Participants will receive 60 mg PO QD on Days 1-21 of the initial run-in and triple-combination periods.
• 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.
• Bevacizumab
Participants will receive 15 mg/kg of IV bevacizumab on Day 1 of each 21-day cycle during the induction and maintenance periods.
• GDC-6036
Participants will receive GDC-6036 PO QD until disease progression or unacceptable toxicity.
• Docetaxel
Participants will receive IV docetaxel Q3W (75 mg/m^2) until disease progression or unacceptable toxicity

Locations

Country	Name	City	State
Algeria	CPMC; Service d'Oncologie Médicale	Algiers
Algeria	CHU Blida; Service d'Oncologie Médicale	Blida
Algeria	EHS Oncologie Emir Abdelkader Oran; Service d'Oncologie Médicale	Oran
Argentina	Fundación CENIT para la Investigación en Neurociencias	Buenos Aires
Argentina	Hospital Italiano	Buenos Aires
Argentina	Hospital Britanico de Buenos Aires	Ciudad Autonoma Buenos Aires
Argentina	Centro Oncologico Riojano Integral (CORI)	La Rioja
Australia	The Prince Charles Hospital; Oncology Dept.	Chermside	Queensland
Australia	Austin Hospital; Medical Oncology	Heidelberg	Victoria
Australia	Ashford Cancer Center Research	Kurralta Park	South Australia
Australia	Sir Charles Gairdner Hospital	Nedlands	Western Australia
Australia	Royal North Shore Hospital; Department of Medical Oncology	St Leonards	New South Wales
Belgium	UZ Brussel	Brussel
Belgium	Cliniques Universitaires St-Luc	Bruxelles
Belgium	UZ Leuven Gasthuisberg	Leuven
Brazil	Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda	Ijui	RS
Brazil	Hospital Sao Lucas - PUCRS	Porto Alegre	RS
Brazil	Instituto Nacional de Cancer - INCa; Oncologia	Rio de Janeiro	RJ
Brazil	Instituto do Cancer do Estado de Sao Paulo - ICESP	Sao Paulo	SP
Canada	Royal Victoria Regional Health Centre; c/o Oncology Clinical Trials	Barrie	Ontario
Canada	William Osler Health System Brampton Civic Hospital	Brampton	Ontario
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	London Health Sciences Centre · Victoria Hospital; Department of Medicine	London	Ontario
Canada	Jewish General Hospital	Montreal	Quebec
Canada	Lakeridge Health Center; R. S. MacLaughlin Durham Regional Cancer Center	Oshawa	Ontario
Canada	IUCPQ (Hôpital Laval)	Quebec City	Quebec
Canada	Saskatoon Cancer Centre	Saskatoon	Saskatchewan
Canada	Princess Margaret Cancer Center	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	CancerCare Manitoba; Department of Medical Oncology	Winnipeg	Manitoba
Chile	Biocenter	Concepción
Chile	Bradford Hill Centro de Investigaciones Clinicas	Recoleta
China	Beijing Cancer Hospital	Beijing
China	Jilin Cancer Hospital	Changchun
China	Hunan Cancer Hospital	Changsha CITY
China	The second Xiangya hospital of central south university	Changsha City
China	Sichuan Cancer Hospital	Chengdu City
China	West China Hospital - Sichuan University	Chengdu City
China	The First Affiliated Hospital of Guangzhou Medical University Pharmacy	Guangzhou
China	Zhejiang Cancer Hospital; Zhejiang Cancer Hospital cancer department	Hangzhou City
China	Harbin Medical University Cancer Hospital	Harbin
China	Shandong Cancer Hospital	Jinan
China	The Second Affiliated Hospital to Nanchang University	Nanchang
China	Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School	Nanjing City
China	Fudan Unviversity Shanghai Cancer Center	Shanghai
China	Xiehe Hospital, Tongji Medical College Huazhong University of Science & Technology	Wuhan
China	First Affiliated Hospital of Medical College of Xi'an Jiaotong University	Xi'an
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou
Costa Rica	Clinica CIMCA	San José
France	Institut Bergonie CLCC Bordeaux	Bordeaux
France	Centre Francois Baclesse; Radiologie	Caen
France	Centre Oscar Lambret	Lille
France	Centre Léon Bérard	Lyon
France	Hopital Caremeau; Pneumologie	Nimes
France	Hopital Bichat Claude Bernard; Oncologie Serv.	Paris
France	Hôpital Européen Georges Pompidou	Paris
France	Hopital Tenon;Pneumologie	Paris
France	CHU Poitiers	Poitiers
France	Hopital Pontchaillou	Rennes
France	CHU de Toulouse - Hôpital Larrey; Service de pneumologie et oncologie pneumologique	Toulouse cedex 9
France	Hopital Bretonneau; Pneumologie Oncologie	Tours
France	Hopital Robert Schuman; Pneumologie	Vantoux
Germany	Klinikum Chemnitz gGmbH	Chemnitz
Germany	Universitätsklinikum Düsseldorf; Klinik für Kardiologie, Pneumologie und Angiologie	Düsseldorf
Germany	Universitätsklinikum Essen; Innere Klinik (Tumorforschung)	Essen
Germany	Klinikum Esslingen; Klinik für Kardiologie, Angiologie und Pneumologie	Esslingen
Germany	Asklepios-Fachklinik Muenchen-Gauting; Klinik Für Pneumologie	Gauting
Germany	Robert Bosch Krankenhaus; Pneumologie und pneumologische Onkologie	Gerlingen
Germany	Thoraxklinik Heidelberg gGmbH	Heidelberg
Germany	HSK Dr.-Horst-Schmidt-Kliniken Klinik für Innere Medizin III Onkologie Hämatologie und Palliativmed	Wiesbaden
Hong Kong	Pamela Youde Nethersole Eastern Hospital	Hong Kong
Hong Kong	Queen Mary Hospital; Medicine & Respiratory	Hong Kong
Hong Kong	Prince of Wales Hosp; Dept. Of Clinical Onc	Shatin
Israel	Soroka Medical Center; Oncology Dept	Beer Sheva
Israel	Rambam Health Care Campus; Oncology	Haifa
Israel	Meir Medical Center; Oncology	Kfar-Saba
Israel	Rabin MC; Davidof Center - Oncology Institute	Petach Tikva
Israel	Chaim Sheba Medical Center; Oncology Dept	Ramat Gan
Israel	Sourasky / Ichilov Hospital; Dept. of Oncology	Tel Aviv
Italy	Irccs Centro Di Riferimento Oncologico (CRO)	Aviano	Friuli-Venezia Giulia
Italy	Asst Papa Giovanni XXIII; Oncologia Medica	Bergamo	Lombardia
Italy	ASST di Cremona - Azienda Socio Sanitaria Territoriale di Cremona	Cremona	Lombardia
Italy	IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica	Meldola	Emilia-Romagna
Italy	Irccs Istituto Europeo di Oncologia (IEO); Divisione di Oncologia	Milano	Lombardia
Italy	Asst Di Monza	Monza	Lombardia
Italy	Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale	Napoli	Campania
Italy	Azienda Sanitaria Ospedaliera S Luigi Gonzaga; S.C.D.U. di Oncologia Toracica	Orbassano (TO)	Piemonte
Italy	Azienda Ospedaliera San Camillo Forlanini	Roma	Lazio
Japan	Fujita Health University Hospital	Aichi
Japan	National Cancer Center Hospital East	Chiba
Japan	Shikoku Cancer Center	Ehime
Japan	Kyushu University Hospital	Fukuoka
Japan	National Hospital Organization Kyushu Cancer Center	Fukuoka
Japan	National Hospital Organization Kyushu Medical Center	Fukuoka
Japan	Hiroshima University Hospital	Hiroshima
Japan	Kanazawa University Hospital	Ishikawa
Japan	Kanagawa Cancer Center	Kanagawa
Japan	Kyoto University Hospital	Kyoto
Japan	University Hospital Kyoto Prefectural University of Medicine	Kyoto
Japan	Sendai Kousei Hospital	Miyagi
Japan	Tohoku University Hospital	Miyagi
Japan	Niigata Cancer Center Hospital	Niigata
Japan	Niigata University Medical & Dental Hospital	Niigata
Japan	Okayama University Hospital	Okayama
Japan	Kindai University Hospital	Osaka
Japan	Saga University Hospital	Saga
Japan	Shizuoka Cancer Center	Shizuoka
Japan	Juntendo University Hospital	Tokyo
Japan	Kyorin University Hospital	Tokyo
Japan	The Cancer Institute Hospital of JFCR	Tokyo
Japan	Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital	Tokyo
Japan	Wakayama Medical University Hospital	Wakayama
Japan	National Hospital Organization Yamaguchi - Ube Medical Center	Yamaguchi
Korea, Republic of	National Cancer Center	Goyang-si
Korea, Republic of	Chonnam National University Hwasun Hospital	Jeollanam-do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Yonsei University Health System/Severance Hospital	Seoul
Mexico	Health Pharma Professional Research	Cdmx	Mexico CITY (federal District)
Mexico	AVIX Investigación Clínica S.C	Monterrey	Nuevo LEON
Mexico	Oncologico Potosino	San Luis Potosí	SAN LUIS Potosi
Mexico	Hospital Angeles Tijuana	Tijuana	BAJA California
Netherlands	UMCG	NL -groningen
Netherlands	Erasmus MC	Rotterdam
New Zealand	Auckland City Hospital	Auckland
Panama	Hemato Oncología de Panamá Especializada	Panama City
Peru	Hospital Nacional Edgardo Rebagliati Martins; Oncologia	Lima
Peru	Instituto Nacional de Enfermedades Neoplasicas	Lima
Peru	Clinica Ricardo Palma	San Isidro
Poland	Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii	Gdansk
Poland	Krakowski Szpital Specjalistyczny im sw.Jana Pawla II	Krakow
Poland	Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii	Olsztyn
Poland	Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii	Otwock
Poland	Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu	Poznan
Poland	Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad; Klinika Nowot.Pluca i Klatki Piers	Warszawa
Russian Federation	Moscow City Oncology Hospital #62	Moscovskaya Oblast	Moskovskaja Oblast
Russian Federation	FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF	Moscow	Moskovskaja Oblast
Russian Federation	Principal Military Clinical Hospital n.a. N.N. Burdenko	Moscow	Moskovskaja Oblast
Russian Federation	Clinical Oncology Dispensary; Chemotherapy	Omsk
Russian Federation	S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)	Saint-Petersburg	Sankt Petersburg
Russian Federation	Saint-Petersburg City Clinical Oncology Dispensary	Sankt-peterburg	Sankt Petersburg
Serbia	Clinical Center of Serbia	Belgrade
Serbia	University Hospital Medical Center Bezanijska kosa	Belgrade
Serbia	Clinical Center Nis	NIS
Serbia	Institute for Pulmonary Diseases of Vojvodina; Clinic for Pulmonary Oncology	Sremska Kamenica
Singapore	National Cancer Centre; Medical Oncology	Singapore
Singapore	National University Hospital; National University Cancer Institute, Singapore (NCIS)	Singapore
Spain	Hospital General Univ. de Alicante	Alicante
Spain	Hospital Clínic i Provincial; Servicio de Hematología y Oncología	Barcelona
Spain	Hospital Universitari Vall d'Hebron; Oncology	Barcelona
Spain	ICO Badalona - Hospital Germans Trias i Pujol	Barcelona
Spain	Insititut Catala D'Oncologia	Hospitalet de Llobregat	Barcelona
Spain	Centro Integral Oncologico Clara Campal; Servicio de Oncología	Madrid
Spain	Hospital General Universitario Gregorio Marañon; Servicio de Oncologia	Madrid
Spain	Hospital Ramon y Cajal; Servicio de Oncologia	Madrid
Spain	Hospital Universitario 12 de Octubre; Servicio de Oncologia	Madrid
Spain	Hospital Universitario Puerta de Hierro; Servicio de Oncologia	Majadahonda	Madrid
Spain	Hospital Regional Universitario Carlos Haya; Servicio de Oncologia	Malaga
Spain	Clinica Universitaria de Navarra; Servicio de Oncologia	Pamplona	Navarra
Spain	Hospital Quiron de Madrid; Servicio de Oncologia	Pozuelo de Alarcon	Madrid
Spain	Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia	Santiago de Compostela	LA Coruña
Spain	Hospital Universitario Virgen del Rocio; Servicio de Oncologia	Sevilla
Spain	Hospital Clínico Universitario de Valencia; Servicio de Oncología	Valencia
Taiwan	Kaohsiung Chang Gung Memorial Hospital; Dept of Internal Medicine	Kaohsiung
Taiwan	National Taiwan Uni Hospital; Internal Medicine	Taipei
Taiwan	Taipei Medical University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology	Taipei
Taiwan	Chang Gung Medical Foundation - Linkou; Chest Dept	Taoyuan
Thailand	Chulalongkorn Hospital; Medical Oncology	Bangkok
Thailand	Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology	Bangkok
Thailand	Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc	Bangkok
Thailand	Prince of Songkla University; Division of Pulmonary Disease, Department of Medicine	Hat Yai
Turkey	Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology	Adana
Turkey	Ankara Bilkent City Hospital	Ankara
Turkey	Liv Hospital Ankara; Medical Oncology	Ankara
Turkey	Akdeniz University Medical Faculty; Medical Oncology Department	Antalya
Turkey	Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department	Edirne
Turkey	Marmara University Pendik Training and Research Hospital; Medikal Onkoloji	Istanbul
Turkey	Medipol University Medical Faculty; Oncology Department	Istanbul
Turkey	Medikal Park Izmir Hospital	Kar??yaka
Turkey	Hacettepe Uni Medical Faculty Hospital; Oncology Dept	Sihhiye/Ankara
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	University Cancer & Blood Center, LLC; Research	Athens	Georgia
United States	Texas Oncology - South Austin	Austin	Texas
United States	St. Luke's University Health network	Bethlehem	Pennsylvania
United States	Montefiore Medical Center	Bronx	New York
United States	Sarah Cannon Research Institute / Tennessee Oncology	Chattanooga	Tennessee
United States	Ohio State University	Columbus	Ohio
United States	Rocky Mountain Cancer Center	Denver	Colorado
United States	Henry Ford Health System; Hematology/Oncology	Detroit	Michigan
United States	Virginia Cancer Specialists, PC	Fairfax	Virginia
United States	SCRI Florida Cancer Specialists South	Fort Myers	Florida
United States	Oncology Consultants PA	Houston	Texas
United States	University of California San Diego	La Jolla	California
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	University of Kentucky; Markey Cancer Center	Lexington	Kentucky
United States	Sarah Cannon Research Institute / Tennessee Oncology	Nashville	Tennessee
United States	Cancer Inst. of New Jersey	New Brunswick	New Jersey
United States	Weill Cornell Medical College-New York Presbyterian Hospital	New York	New York
United States	Eastern Connecticut Hematology and Oncology Associates; (ECHO)	Norwich	Connecticut
United States	Illinois Cancer Care	Peoria	Illinois
United States	Oregon HSU	Portland	Oregon
United States	UC Davis; Comprehensive Cancer Center	Sacramento	California
United States	Florida Cancer Specialist, North Region	Saint Petersburg	Florida
United States	University of Washington Seattle Cancer Care Alliance	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Algeria,  Argentina,  Australia,  Belgium,  Brazil,  Canada,  Chile,  China,  Costa Rica,  France,  Germany,  Hong Kong,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  New Zealand,  Panama,  Peru,  Poland,  Russian Federation,  Serbia,  Singapore,  Spain,  Taiwan,  Thailand,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Baseline up to disease progression or death (up to approximately 6 years)
Primary	Cohort B: Percentage of Participants with Confirmed Objective Response as Assessed by the Investigator Based on RECIST v1.1		Baseline up to disease progression or death (up to approximately 6 years)
Primary	Cohort C: Progression Free Survival (PFS) as Assessed by the Investigator Based on RECIST v1.1 in bTMB PP1		Baseline up to disease progression or death (up to approximately 6 years)
Primary	Cohort D: Percentage of Participants with Confirmed Objective Response as Assessed by the Investigator Based on RECIST v1.1		Baseline up to disease progression or death (up to approximately 6 years)
Primary	Cohort E: Time in Response (TIR) as Assessed by the Investigator Based on RECIST v1.1		Month 12
Primary	Cohort F: Investigator-Assessed Objective Response Rate (ORR) Based on RECIST v1.1		Baseline up to disease progression or death (up to approximately 6 years)
Primary	Cohort G: PFS as Determined by Blinded Independent Central Review (BICR) Based on RECIST v1.1		Baseline up to disease progression or death (up to approximately 6 years)
Secondary	All Cohorts: Duration of Response (DOR) as Assessed by the Investigator Based on RECIST v1.1		Baseline up to disease progression or death (up to approximately 6 years)
Secondary	Cohorts A, B and D: Percentage of Participants with Clinical Benefit Response as Assessed by the Investigator Based on RECIST v1.1		Baseline up to disease progression or death (up to approximately 6 years)
Secondary	Cohorts A, B, D, F, G: PFS as Assessed by the Investigator Based on RECIST v1.1		Baseline up to disease progression or death (up to approximately 6 years)
Secondary	Cohorts A-F: Duration of Response as Assessed by the Independent Review Facility (IRF) Based on RECIST v1.1		Baseline up to disease progression or death (up to approximately 6 years)
Secondary	Cohorts A, B and D: Percentage of Participants with Clinical Benefit Response as Assessed by IRF Based on RECIST v1.1		Baseline up to disease progression or death (up to approximately 6 years)
Secondary	Cohorts A-F: PFS as Assessed by IRF Based on RECIST v1.1		Baseline up to disease progression or death (up to approximately 6 years)
Secondary	Cohorts A-F: Percentage of Participants with Confirmed Objective Response as Assessed by IRF Based on RECIST v1.1		Baseline up to disease progression or death (up to approximately 6 years)
Secondary	All Cohorts: Overall Survival (OS)		Baseline up to approximately 6 years
Secondary	All Cohorts: Percentage of Participants with Adverse Events (AEs)		Baseline up to approximately 6 years
Secondary	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)		Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years
Secondary	Cohorts A-F: Time to Deterioration in Patient-Reported Lung Cancer Symptoms (Cough, Dyspnea and Chest Pain) as Measured by the SILC Scale		Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years
Secondary	Cohorts C, E, F: Change from Baseline in Patient-Reported Lung Cancer Symptom (Cough, Dyspnea, Chest pain) Score as Measured by the SILC Scale		Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years
Secondary	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)		Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years
Secondary	Cohorts A, B, D, E, F: Change from Baseline in HRQoL Scores as Measured by the SILC Scale		Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years
Secondary	All Cohorts: Change from Baseline in Patient Functioning and Symptoms Score as Measured by the EORTC QLQ-C30		Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years
Secondary	Cohorts A, B, D, E, F: Change from Baseline in Patient Functioning and Symptoms Score as Measured by the SILC Scale		Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years
Secondary	All Cohorts: Health Status Assessed as an Index Score Using the European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire		Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years
Secondary	Cohort B: Percentage of Participants with Dose-Limiting Toxicities (DLTs)		Day 1 to Day 28 of Cycle 1 (cycle length = 28 days)
Secondary	Cohort B: Maximum Plasma Concentration (Cmax) of Alectinib	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)
Secondary	Cohort B: Area Under the Concentration-Time Curve from Time Zero to the Last Measurable Concentration (AUC0-last) of Alectinib		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)
Secondary	Cohort B: Time to Reach Cmax (Tmax) of Alectinib		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)
Secondary	Cohort B: Half-Life (t1/2) of Alectinib		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)
Secondary	Cohort B: Metabolite to Parent Exposure Ratio for AUC0-last		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)
Secondary	Cohort B: Metabolite to Parent Exposure Ratio for Cmax		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)
Secondary	Cohort C: Percentage of Participants with Objective Response as Assessed by the Investigator Based on RECIST v1.1		Baseline up to disease progression or death (up to approximately 6 years)
Secondary	Cohort C: Percentage of Participants Free from Disease Progression as Assessed by the Investigator Based on RECIST v1.1 at Months 6 and 12		Months 6, 12
Secondary	Cohort C: PFS as Assessed by the Investigator based on RECIST v1.1 in bTMB PP2		Baseline up to disease progression or death (up to approximately 6 years)
Secondary	Cohort C: OS in bTMB PP2		Baseline up to approximately 6 years
Secondary	Cohort D: Time to CNS progression as Assessed by the Investigator Based on RECIST v1.1		Baseline up to CNS progression (up to approximately 6 years)
Secondary	Cohort D: Time to CNS progression as Assessed by the IRF Based on RECIST v1.1		Baseline up to CNS progression (up to approximately 6 years)
Secondary	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		Baseline, every 4 weeks until disease progression, up to approximately 6 years
Secondary	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		Baseline, every 4 weeks until disease progression, up to approximately 6 years
Secondary	Cohort D: Mean Plasma Concentration of Entrectinib		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).
Secondary	Cohort D: Mean Plasma Concentration of Entrectinib Metabolite M5		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).
Secondary	Cohort E: TIR as Assessed by the Investigator Based on RECIST v1.1		Month 9
Secondary	Cohort E: TIR as Assessed by IRF		Month 12
Secondary	Cohorts E, F: Serum Concentration of Atezolizumab		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)
Secondary	Cohorts E, F: Change from Baseline in Anti-Drug Antibodies (ADAs)		Baseline up to approximately 6 years
Secondary	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)		Baseline up to approximately 6 years
Secondary	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		Baseline up to approximately 6 years
Secondary	Cohort G: Objective Response Rate (ORR) as Assessed by the Investigator Based on RECIST v1.1		Baseline up to approximately 6 years
Secondary	Cohort G: TTCD on the EORTC QLQ-C30 Physical Functioning and Role Functioning Scales		Baseline up to approximately 6 years
Secondary	Cohort G: Proportion of Participants Reporting Clinically Meaningful Deterioration in Fatigue, Chest Pain, Physical and Role Functioning as Measured by the EORTC QLQ-LC13 and QLQ-C30 Questionnaires		Cycle 5 (1 cycle = 21 or 28 days)
Secondary	Cohort G: Change from Baseline in Fatigue, Chest Pain, Physical and Role Functioning as Measured by the EORTC QLQ-LC13 and QLQ-C30 Questionnaires		Cycle 5 (1 cycle = 21 or 28 days)
Secondary	Cohort G: Tolerability of GDC-6036 or Docetaxel as Assessed by the Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE)		Cycles 1-3 (1 cycle = 21 days)
Secondary	Cohort G: Plasma Concentration of GDC-6036		Cycles 1-5 (1 cycle = 21 days)