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

PHASE2/PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

1,000

Participants

Timeline

Start Date

September 22, 2017

Primary Completion Date

October 31, 2026

Study Completion Date

October 31, 2026

Conditions
Non-Small Cell Lung Cancer
Interventions
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.

DRUG

Atezolizumab

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

DRUG

Pemetrexed

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

DRUG

Cisplatin

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

DRUG

Carboplatin

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

DRUG

Gemcitabine

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

DRUG

Entrectinib

Participants will receive entrectinib 600 mg orally QD.

DRUG

Cobimetinib

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

DRUG

Vemurafenib

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

DRUG

Bevacizumab

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

DRUG

Divarasib

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

DRUG

Docetaxel

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

Trial Locations (161)

11

Hospital Nacional Edgardo Rebagliati Martins, Lima

100

National Taiwan Uni Hospital, Taipei

112

Taipei Veterans General Hospital, Taipei

333

Chang Gung Medical Foundation - Linkou, Taoyuan District

1023

Auckland City Hospital, Auckland

1090

UZ Brussel, Brussels

2065

Royal North Shore Hospital, St Leonards

3000

UZ Leuven Gasthuisberg, Leuven

4032

The Prince Charles Hospital, Chermside

5037

Ashford Cancer Center Research, Kurralta Park

10021

Weill Cornell Medical College-New York Presbyterian Hospital, New York

10043

Azienda Sanitaria Ospedaliera S Luigi Gonzaga, Orbassano (TO)

10330

Chulalongkorn Hospital, Bangkok

10400

Ramathibodi Hospital, Bangkok

10408

National Cancer Center, Gyeonggi-do

10461

Montefiore Medical Center, The Bronx

10700

Faculty of Med. Siriraj Hosp., Bangkok

11000

Clinical Center of Serbia, Belgrade

11080

University Hospital Medical Center Bezanijska kosa, Belgrade

15038

Instituto Nacional de Enfermedades Neoplasicas, Lima

15706

Complejo Hospitalario Universitario de Santiago (CHUS), Santiago de Compostela

18000

Clinical Center Nis, Niš

18015

St. Luke's University Health network, Bethlehem

20141

Irccs Istituto Europeo di Oncologia (IEO), Milan

20900

Asst Di Monza, Monza

22010

Hospital Angeles Tijuana, Tijuana

22770

Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department, Edirne

24128

Asst Papa Giovanni XXIII, Bergamo

26100

ASST di Cremona - Azienda Socio Sanitaria Territoriale di Cremona, Cremona

28007

Hospital General Universitario Gregorio Marañon, Madrid

28034

Hospital Ramon y Cajal, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28050

Centro Integral Oncologico Clara Campal, Madrid

28222

Hospital Universitario Puerta de Hierro, Madrid

28223

Hospital Quiron de Madrid, Madrid

29010

Hospital Regional Universitario Carlos Haya, Málaga

30029

Hopital Caremeau, Nîmes

31008

Clinica Universitaria de Navarra, Pamplona

31059

CHU de Toulouse - Hôpital Larrey, Toulouse

33081

Irccs Centro Di Riferimento Oncologico (CRO), Aviano

33705

Florida Cancer Specialist, North Region, St. Petersburg

33901

SCRI Florida Cancer Specialists South, Fort Myers

34214

Medipol University Medical Faculty; Oncology Department, Istanbul

34890

Marmara University Pendik Training and Research Hospital; Medikal Onkoloji, Istanbul

35033

Hopital Pontchaillou, Rennes

35575

Medikal Park Izmir Hospital, Kar??yaka

37203

Sarah Cannon Research Institute / Tennessee Oncology, Nashville

37404

Sarah Cannon Research Institute / Tennessee Oncology, Chattanooga

40536

University of Kentucky, Lexington

41013

Hospital Universitario Virgen del Rocio, Seville

46010

Hospital Clínico Universitario de Valencia, Valencia

47014

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

58128

Chonnam National University Hwasun Hospital, Jeollanam-do

59020

Centre Oscar Lambret, Lille

64710

AVIX Investigación Clínica S.C, Monterrey

65199

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

69126

Thoraxklinik Heidelberg gGmbH, Heidelberg

69373

Centre Léon Bérard, Lyon

73730

Klinikum Esslingen, Esslingen am Neckar

75908

Hôpital Européen Georges Pompidou, Paris

75970

Hopital Tenon, Paris

78250

Oncologico Potosino, San Luis Potosí City

80131

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

80218

Rocky Mountain Cancer Center, Denver

82131

Asklepios-Fachklinik Muenchen-Gauting, Gauting

83301

Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City

86021

CHU Poitiers, Poitiers

89128

Comprehensive Cancer Centers of Nevada, Las Vegas

90110

Prince of Songkla University, Hat Yai

95817

UC Davis, Sacramento

97210

Oregon HSU, Portland

100142

Beijing Cancer Hospital, Beijing

105229

Principal Military Clinical Hospital n.a. N.N. Burdenko, Moscow

119228

National University Hospital, Singapore

143423

Moscow City Oncology Hospital #62, Moscovskaya Oblast

169610

National Cancer Centre, Singapore

197758

S-Pb clinical scientific practical center of specialized kinds of medical care (oncological), Saint Petersburg

200032

Fudan Unviversity Shanghai Cancer Center, Shanghai

210008

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

250117

Shandong Cancer Hospital, Jinan

310022

Zhejiang Cancer Hospital, Hangzhou

330006

The Second Affiliated Hospital to Nanchang University, Nanchang

410013

Hunan Cancer Hospital, Changsha

410100

The second Xiangya hospital of central south university, Changsha

510120

The First Affiliated Hospital of Guangzhou Medical University Pharmacy, Guangzhou

610041

Sichuan Cancer Hospital, Chengdu

610047

West China Hospital - Sichuan University, Chengdu

644013

Clinical Oncology Dispensary, Omsk

710061

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

3109601

Rambam Health Care Campus, Haifa

4428164

Meir Medical Center, Kfar Saba

4941492

Rabin MC, Petah Tikva

5262100

Chaim Sheba Medical Center, Ramat Gan

6423906

Sourasky / Ichilov Hospital; Dept. of Oncology, Tel Aviv

8410101

Soroka Medical Center, Beersheba

8420383

Bradford Hill Centro de Investigaciones Clinicas, Recoleta

03756

Dartmouth Hitchcock Medical Center, Lebanon

C1125ABD

Fundación CENIT para la Investigación en Neurociencias, Buenos Aires

C1181ACH

Hospital Italiano, Buenos Aires

C1284AEB

Hospital Britanico de Buenos Aires, Ciudad Autonoma Buenos Aires

98700-000

Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda, Ijuí

90610-000

Hospital Sao Lucas - PUCRS, Porto Alegre

01246-000

Instituto do Cancer do Estado de Sao Paulo - ICESP, São Paulo

T6G 1Z2

Cross Cancer Institute, Edmonton

R3E 0V9

CancerCare Manitoba, Winnipeg

L4M 6M2

Royal Victoria Regional Health Centre, Barrie

L6R 3J7

William Osler Health System Brampton Civic Hospital, Brampton

N6A 5W9

London Health Sciences Centre · Victoria Hospital, London

L1G 2B9

Lakeridge Health Center, Oshawa

M4N 3M5

Sunnybrook Health Sciences Centre, Toronto

M5G 1Z5

Princess Margaret Cancer Center, Toronto

H3T 1E2

Jewish General Hospital, Montreal

G1V 4G5

IUCPQ (Hôpital Laval), Québec

SK S7N 4H4

Saskatoon Cancer Centre, Saskatoon

09116

Klinikum Chemnitz gGmbH, Chemnitz

Unknown

Queen Mary Hospital, Hong Kong

Prince of Wales Hosp, Shatin

Instituto Peruano de Oncología y Radioterapia, Lima

00151

Azienda Ospedaliera San Camillo Forlanini, Rome

113-8677

Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital, Bunkyō City

810-8563

National Hospital Organization Kyushu Medical Center, Fukuoka

811-1395

National Hospital Organization Kyushu Cancer Center, Fukuoka

812-8582

Kyushu University Hospital, Fukuoka

734-8551

Hiroshima University Hospital, Hiroshima

920-8641

Kanazawa University Hospital, Ishikawa

241-8515

Kanagawa Cancer Center, Kanagawa

602-8566

University Hospital Kyoto Prefectural University of Medicine, Kyoto

791-0280

Shikoku Cancer Center, Matsuyama

980-8574

Tohoku University Hospital, Miyagi

981-0914

Sendai Kousei Hospital, Miyagi

951-8520

Niigata University Medical & Dental Hospital, Niigata

951-8566

Niigata Cancer Center Hospital, Niigata

589-8511

Kindai University Hospital, Osaka

849-8501

Saga University Hospital, Saga

411-8777

Shizuoka Cancer Center, Shizuoka

113-8431

Juntendo University Hospital, Tokyo

135-8550

The Cancer Institute Hospital of JFCR, Tokyo

181-8611

Kyorin University Hospital, Tokyo

470-1192

Fujita Health University Hospital, Toyoake-shi

641-8510

Wakayama Medical University Hospital, Wakayama

775-0241

National Hospital Organization Yamaguchi - Ube Medical Center, Yamaguchi

03100

Health Pharma Professional Research, Mexico City

0801

Hemato Oncología de Panamá Especializada, Panama City

Lima 27

Clinica Ricardo Palma, San Isidro

80-214

Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii, Gda?sk

31-202

Krakowski Szpital Specjalistyczny im sw.Jana Pawla II, Krakow

10-357

Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie, Olsztyn

05-400

Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy, Otwock

60-569

Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu, Poznan

02-781

Centrum Onkologii Instytut im.Marii Sklodowskiej-Curie, Warsaw

03080

Seoul National University Hospital, Seoul

05505

Asan Medical Center, Seoul

120-752

Yonsei University Health System/Severance Hospital, Seoul

08908

Insititut Catala D'Oncologia, L'Hospitalet de Llobregat

03010

Hospital General Univ. de Alicante, Alicante

08035

Hospital Universitari Vall d'Hebron, Barcelona

08036

Hospital Clínic i Provincial, Barcelona

08916

ICO Badalona - Hospital Germans Trias i Pujol, Barcelona

01230

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

07070

Akdeniz University Medical Faculty; Medical Oncology Department, Antalya

06230

Hacettepe Uni Medical Faculty Hospital; Oncology Dept, Sihhiye/Ankara

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT03178552 - A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC) | Biotech Hunter | Biotech Hunter