A Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib in Combination With Other Anti-Cancer Therapies in Participants With Previously Untreated Advanced or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

240

Participants

Timeline

Start Date

June 20, 2023

Primary Completion Date

January 29, 2032

Study Completion Date

January 29, 2032

Conditions
Non-Small Cell Lung Cancer
Interventions
DRUG

Divarasib

Participants will receive one of two doses of divarasib orally (PO), QD on days 1-21 of each 21-day cycle.

DRUG

Pembrolizumab

Participants will receive a 200 mg IV infusion of pembrolizumab Q3W on Day 1 of each 21-day cycle.

DRUG

Carboplatin

Participants will receive IV carboplatin Q3W for four 21-day cycles.

DRUG

Cisplatin

Participants will receive IV cisplatin Q3W for four 21-day cycles.

DRUG

Pemetrexed

Participants will receive IV pemetrexed Q3W.

Trial Locations (70)

100

RECRUITING

National Taiwan Uni Hospital, Taipei

333

ACTIVE_NOT_RECRUITING

Chang Gung Medical Foundation - Linkou, Taoyuan District

407

RECRUITING

Taichung Veterans General Hospital, Taichung

1200

RECRUITING

Cliniques Universitaires St-Luc, Brussels

2139

COMPLETED

Concord Repatriation General Hospital, Concord

3000

RECRUITING

Peter MacCallum Cancer Centre, Melbourne

3004

RECRUITING

Alfred Health, Melbourne

3010

WITHDRAWN

Inselspital Bern, Bern

3500

RECRUITING

Jessa Zkh (Campus Virga Jesse), Hasselt

4031

ACTIVE_NOT_RECRUITING

Universitätsspital Basel, Basel

5000

RECRUITING

Clinique Ste-Elisabeth, Namur

8800

RECRUITING

AZ Delta (Campus Rumbeke), Roeselare

10016

RECRUITING

NYU Cancer Center, New York

10029

RECRUITING

Mount SInai Medical Center, New York

10043

RECRUITING

A.O. Universitaria S. Luigi Gonzaga, Orbassano

11501

RECRUITING

NYU Langone Hospital - Long Island, Mineola

20133

RECRUITING

Irccs Istituto Nazionale Dei Tumori (Int), Milan

23502

RECRUITING

Virginia Oncology Associates, Norfolk

24060

RECRUITING

Oncology & Hematology Associates of Southwest Virginia, Inc, Blacksburg

28007

RECRUITING

Hospital General Universitario Gregorio Marañon, Madrid

28041

RECRUITING

Hospital Universitario 12 de Octubre, Madrid

41013

RECRUITING

Hospital Universitario Virgen del Rocio, Seville

46010

ACTIVE_NOT_RECRUITING

Hospital Clinico Universitario de Valencia, Valencia

49241

RECRUITING

Pusan National University Hospital, Busan

77030

RECRUITING

MD Anderson Cancer Center, Houston

80131

WITHDRAWN

Istituto Nazionale Tumori Fondazione G. Pascale, Napoli

90813

RECRUITING

City of Hope - Long Beach Elm, Long Beach

91010

RECRUITING

City of Hope National Medical Center, Duarte

92093

WITHDRAWN

UCSD Moores Cancer Center, La Jolla

92618

RECRUITING

City of Hope at Irvine Lennar, Irvine

92648

RECRUITING

City of Hope - Seacliff, Huntington Beach

150081

RECRUITING

Harbin Medical University Cancer Hospital, Harbin

200433

ACTIVE_NOT_RECRUITING

Shanghai Pulmonary Hospital, Shanghai

410013

ACTIVE_NOT_RECRUITING

Hunan Cancer Hospital, Changsha

3109601

RECRUITING

Rambam Medical Center, Haifa

4941492

RECRUITING

Rabin MC, Petah Tikva

6423906

RECRUITING

Tel Aviv Sourasky Medical Ctr, Tel Aviv

06520

RECRUITING

Yale Cancer Center, New Haven

33901-8108

RECRUITING

Florida Cancer Specialists - SOUTH - SCRI - PPDS, Fort Myers

33705-1400

RECRUITING

Florida Cancer Specialists - NORTH - SCRI - PPDS, St. Petersburg

33401-3406

RECRUITING

Florida Cancer Specialists - EAST - SCRI - PPDS, West Palm Beach

C1280AEB

RECRUITING

Hospital Britanico, Buenos Aires

C1430EGF

RECRUITING

Clinica Adventista Belgrano, Ciudad Autonoma Buenos Aires

F5300COE

RECRUITING

Centro Oncologico Riojano Integral (CORI), La Rioja

14784-400

RECRUITING

Hospital de Cancer de Barretos, Barretos

01246-000

RECRUITING

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

K1H 8M2

RECRUITING

Ottawa Hospital Regional Cancer Centre, Ottawa

M5G 1Z5

ACTIVE_NOT_RECRUITING

Princess Margaret Cancer Center, Toronto

H3T 1E2

RECRUITING

Jewish General Hospital, Montreal

00168

ACTIVE_NOT_RECRUITING

Policlinico Universitario Agostino Gemelli IRCCS, Rome

277-8577

RECRUITING

National Cancer Center Hospital East, Chiba

589-8511

RECRUITING

Kindai University Hospital, Osaka

104-0045

RECRUITING

National Cancer Center Hospital, Tokyo

135-8550

RECRUITING

The Cancer Institute Hospital of JFCR, Tokyo

641-8510

RECRUITING

Wakayama Medical University Hospital, Wakayama

1066 CX

ACTIVE_NOT_RECRUITING

NKI The Netherlands Cancer Institute, Amsterdam

6525 GA

RECRUITING

UMC St Radboud, Nijmegen

80-214

RECRUITING

Uniwersyteckie Centrum Kliniczne, Gda?sk

31-202

RECRUITING

Krakowski Szpital Specjalistyczny im sw. Jana Paw?a II, Krakow

10-357

ACTIVE_NOT_RECRUITING

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

03080

RECRUITING

Seoul National University Hospital, Seoul

05505

RECRUITING

Asan Medical Center, Seoul

06351

RECRUITING

Samsung Medical Center, Seoul

08308

RECRUITING

Korea University Guro Hospital, Seoul

08916

RECRUITING

ICO Badalona-H.U. Germans Trias i Pujol, Badalona

08035

RECRUITING

Vall d?Hebron Institute of Oncology (VHIO), Barcelona, Barcelona

411 36

RECRUITING

Sahlgrenska University Hospital, Gothenburg

Unknown

RECRUITING

National Cheng Kung University Hospital, Tainan City

G12 0YN

RECRUITING

Beatson West of Scotland Cancer Centre, Glasgow

EC1A 7BE

RECRUITING

Barts & London School of Med, London

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY