Clinical Trials Logo

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
First received
Last updated
Start date September 22, 2017
Est. completion date August 3, 2028

Study information

Verified date May 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
Health authority
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

Study Design


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
Kenya Aga Khan University Hospital Nairobi
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,  Kenya,  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)
See also
  Status Clinical Trial Phase
Terminated NCT03087448 - Ceritinib + Trametinib in Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer (NSCLC) Phase 1
Recruiting NCT05042375 - A Trial of Camrelizumab Combined With Famitinib Malate in Treatment Naïve Subjects With PD-L1-Positive Recurrent or Metastatic Non-Small Cell Lung Cancer Phase 3
Completed NCT02526017 - Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers Phase 1
Enrolling by invitation NCT00068003 - Harvesting Cells for Experimental Cancer Treatments
Terminated NCT05414123 - A Therapy Treatment Response Trial in Patients With Leptomeningeal Metastases ((LM) Using CNSide
Recruiting NCT05059444 - ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
Recruiting NCT05919537 - Study of an Anti-HER3 Antibody, HMBD-001, With or Without Chemotherapy in Patients With Solid Tumors Harboring an NRG1 Fusion or HER3 Mutation Phase 1
Recruiting NCT05009836 - Clinical Study on Savolitinib + Osimertinib in Treatment of EGFRm+/MET+ Locally Advanced or Metastatic NSCLC Phase 3
Recruiting NCT03412877 - Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer Phase 2
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Completed NCT03219970 - Efficacy and Safety of Osimertinib for HK Chinese With Metastatic T790M Mutated NSCLC-real World Setting.
Recruiting NCT05949619 - A Study of BL-M02D1 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer or Other Solid Tumors Phase 1/Phase 2
Recruiting NCT04054531 - Study of KN046 With Chemotherapy in First Line Advanced NSCLC Phase 2
Withdrawn NCT03519958 - Epidermal Growth Factor Receptor (EGFR) T790M Mutation Testing Practices in Hong Kong
Completed NCT03384511 - The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies. Phase 4
Terminated NCT02580708 - Phase 1/2 Study of the Safety and Efficacy of Rociletinib in Combination With Trametinib in Patients With mEGFR-positive Advanced or Metastatic Non-small Cell Lung Cancer Phase 1/Phase 2
Completed NCT01871805 - A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC) Phase 1/Phase 2
Terminated NCT04042480 - A Study of SGN-CD228A in Advanced Solid Tumors Phase 1
Recruiting NCT05919641 - LIVELUNG - Impact of CGA in Patients Diagnosed With Localized NSCLC Treated With SBRT
Completed NCT03656705 - CCCR-NK92 Cells Immunotherapy for Non-small Cell Lung Carcinoma Phase 1