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RECRUITING

NCT05789082

PHASE1/PHASE2

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

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

320

Start Date

2023-06-20

Completion Date

2032-01-29

Last Updated

2026-03-19

Healthy Volunteers

Conditions

Non-Small Cell Lung Cancer

Interventions

DRUG

Divarasib

Participants will receive 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.

Inclusion Criteria: * Confirmation of Biomarker eligibility * Pre-treatment tumor tissue along with an associated pathology report is required for all participants enrolled on study. Representative tumor specimens must be in formalin-fixed, paraffin embedded (FFPE) blocks (preferred) or 15 unstained, freshly cut, serial slides. Although 15 slides are required, if only 10 slides are available, the participant may be eligible for the study following consultation with the Sponsor. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 * Histologically or cytologically documented locally advanced unresectable or metastatic NSCLC that is not eligible for curative surgery and/or definitive chemoradiotherapy * No prior systemic treatment for advanced unresectable or metastatic NSCLC * Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Additionally, for participants in cohort D, measurable brain metastases defined as at least 5 millimeters and twice the slice thickness, but less than 20 mm, that is asymptomatic and does not require local therapy at the time of enrollment. Exclusion Criteria: * Known concomitant second oncogenic driver with available targeted treatment * Squamous cell histology NSCLC * Symptomatic, untreated, or actively progressing CNS metastases (Cohorts A, B, and C) * Prior treatment with a KRAS G12C inhibitor * Known hypersensitivity to any of the components of divarasib or pembrolizumab; or known hypersensitivity to pemetrexed, carboplatin, or cisplatin (Cohort B only) * History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis, active tuberculosis, significant cardiovascular disease within 3 months prior to initiation of study treatment * History of malignancy other than NSCLC within 5 years prior to initiation of study treatment, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate more \>90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal breast carcinoma in situ, or Stage I uterine cancer * Uncontrolled tumor related pain, pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures, uncontrolled or symptomatic hypercalcemia * Co-morbid condition that is an absolute contraindication to treatment with corticosteroids * Inability or unwillingness to take prophylactic treatments such as corticosteroids, anti-emetics, folic acid, or vitamin B12 supplementation. * Participants with brain metastases for whom complete surgical resections is clinically appropriate

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 District, Taiwan

Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom

Barts & London School of Med

London, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (71)