RecruitingPhase 1Phase 2NCT05789082

A Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib as a Single Agent or 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

A Phase Ib/II, Open-Label, Multicenter Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib as a Single Agent or in Combination With Other Anti-Cancer Therapies in Patients With Previously Untreated Advanced Or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation

Sponsor

Hoffmann-La Roche

Enrollment

320 participants

Start Date

Jun 20, 2023

Study Type

INTERVENTIONAL

Summary

The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and activity of single-agent divarasib or combined with other anti-cancer therapies in participants with previously untreated, advanced or metastatic non-small cell lung cancer (NSCLC).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing divarasib — a drug that targets a specific cancer mutation called KRAS G12C — alone or combined with other treatments in people with previously untreated advanced non-small cell lung cancer (NSCLC). KRAS G12C is a common mutation that drives tumor growth in some lung cancers. **You may be eligible if...** - You have advanced or metastatic non-small cell lung cancer with a confirmed KRAS G12C mutation - You have not yet received any systemic treatment for your advanced-stage lung cancer - Your cancer is measurable on scans - Your overall health status is good (ECOG 0 or 1) - A tumor tissue sample is available for biomarker testing **You may NOT be eligible if...** - You have squamous cell lung cancer - You have a second cancer-driving mutation with available targeted therapy - You have previously been treated with a KRAS G12C inhibitor - You have active, symptomatic brain metastases (for most study groups) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDivarasib

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

DRUGPembrolizumab

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

DRUGCarboplatin

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

DRUGCisplatin

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

DRUGPemetrexed

Participants will receive IV pemetrexed Q3W.

Locations(71)

City of Hope National Medical Center

Duarte, California, United States

City of Hope - Seacliff

Huntington Beach, California, United States

City of Hope at Irvine Lennar

Irvine, California, United States

UCSD Moores Cancer Center

La Jolla, California, United States

City of Hope - Long Beach Elm

Long Beach, California, United States

Yale Cancer Center

New Haven, Connecticut, United States

Florida Cancer Specialists - SOUTH - SCRI - PPDS

Fort Myers, Florida, United States

Florida Cancer Specialists - NORTH - SCRI - PPDS

St. Petersburg, Florida, United States

Florida Cancer Specialists - EAST - SCRI - PPDS

West Palm Beach, Florida, United States

NYU Langone Hospital - Long Island

Mineola, New York, United States

NYU Cancer Center

New York, New York, United States

Mount SInai Medical Center

New York, New York, United States

Montefiore Medical Center - Montefiore Medical Park

The Bronx, New York, United States

MD Anderson Cancer Center

Houston, Texas, United States

Oncology & Hematology Associates of Southwest Virginia, Inc

Blacksburg, Virginia, United States

Virginia Oncology Associates

Norfolk, Virginia, United States

Hospital Britanico

Buenos Aires, Argentina

Clinica Adventista Belgrano

Ciudad Autonoma Buenos Aires, Argentina

Centro Oncologico Riojano Integral (CORI)

La Rioja, Argentina

Concord Repatriation General Hospital

Concord, New South Wales, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Alfred Health

Melbourne, Victoria, Australia

Cliniques Universitaires St-Luc

Brussels, Belgium

Jessa Zkh (Campus Virga Jesse)

Hasselt, Belgium

Clinique Ste-Elisabeth

Namur, Belgium

AZ Delta (Campus Rumbeke)

Roeselare, Belgium

Hospital de Cancer de Barretos

Barretos, São Paulo, Brazil

Instituto do Cancer do Estado de Sao Paulo - ICESP

São Paulo, São Paulo, Brazil

Ottawa Hospital Regional Cancer Centre

Ottawa, Ontario, Canada

Princess Margaret Cancer Center

Toronto, Ontario, Canada

Jewish General Hospital

Montreal, Quebec, Canada

Hunan Cancer Hospital

Changsha, China

Harbin Medical University Cancer Hospital

Harbin, China

Shanghai Pulmonary Hospital

Shanghai, China

Rambam Medical Center

Haifa, Israel

Rabin MC

Petah Tikva, Israel

Tel Aviv Sourasky Medical Ctr

Tel Aviv, Israel

Istituto Nazionale Tumori Fondazione G. Pascale

Naples, Campania, Italy

Policlinico Universitario Agostino Gemelli IRCCS

Rome, Lazio, Italy

Irccs Istituto Nazionale Dei Tumori (Int)

Milan, Lombardy, Italy

A.O. Universitaria S. Luigi Gonzaga

Orbassano, Piedmont, Italy

National Cancer Center Hospital East

Chiba, Japan

Kindai University Hospital

Osaka, Japan

National Cancer Center Hospital

Tokyo, Japan

The Cancer Institute Hospital of JFCR

Tokyo, Japan

Wakayama Medical University Hospital

Wakayama, Japan

NKI The Netherlands Cancer Institute

Amsterdam, Netherlands

UMC St Radboud

Nijmegen, Netherlands

Uniwersyteckie Centrum Kliniczne

Gda?sk, Poland

Krakowski Szpital Specjalistyczny im sw. Jana Paw?a II

Krakow, Poland

Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie

Olsztyn, Poland

Pusan National University Hospital

Busan, South Korea

Seoul National University Hospital

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Korea University Guro Hospital

Seoul, South Korea

ICO Badalona-H.U. Germans Trias i Pujol

Badalona, Barcelona, Spain

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

Barcelona, Spain

Hospital General Universitario Gregorio Marañon

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario Virgen del Rocio

Seville, Spain

Hospital Clinico Universitario de Valencia

Valencia, Spain

Sahlgrenska University Hospital

Gothenburg, Sweden

Universitätsspital Basel

Basel, Switzerland

Inselspital Bern

Bern, Switzerland

Taichung Veterans General Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan Uni Hospital

Taipei, Taiwan

Chang Gung Medical Foundation - Linkou

Taoyuan, Taiwan

Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom

Barts & London School of Med

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05789082