Lung Cancer Clinical Trial
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
Summary
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and activity of divarasib combined with other anti-cancer therapies in participants with previously untreated, advanced or metastatic non-small cell lung cancer (NSCLC).
Eligibility Criteria
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
Exclusion Criteria:
Known concomitant second oncogenic driver with available targeted treatment
Squamous cell histology NSCLC
Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
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
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There are 53 Locations for this study
New Haven Connecticut, 06520, United States
Mineola New York, 11501, United States
New York New York, 10016, United States
Buenos Aires , C1280, Argentina
Ciudad Autonoma Buenos Aires , C1430, Argentina
La Rioja , F5300, Argentina
Concord New South Wales, 2139, Australia
Melbourne Victoria, 3000, Australia
Melbourne Victoria, 3004, Australia
Bruxelles , 1200, Belgium
Hasselt , 3500, Belgium
Namur , 5000, Belgium
Roeselare , 8800, Belgium
Fortaleza CE, 60336, Brazil
Porto Alegre RS, 90040, Brazil
Barretos SP, 14784, Brazil
Sao Paulo SP, 01246, Brazil
Toronto Ontario, M5G 1, Canada
Montreal Quebec, H3T 1, Canada
Changsha CITY , 41001, China
Harbin , 15008, China
Shanghai , 20043, China
Haifa , 31096, Israel
Petach Tikva , 49414, Israel
Tel Aviv , 64239, Israel
Napoli Campania, 80131, Italy
Roma Lazio, 00168, Italy
Orbassano Piemonte, 10043, Italy
Busan , 602-7, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 08308, Korea, Republic of
Amsterdam , 1066 , Netherlands
Nijmegen , 6525 , Netherlands
Gda?sk , 80-21, Poland
Kraków , 31-20, Poland
Olsztyn , 10-35, Poland
Badalona Barcelona, 08916, Spain
Pozuelo de Alarcon Madrid, 28223, Spain
Barcelona , 08035, Spain
Madrid , 28007, Spain
Sevilla , 41013, Spain
Göteborg , 413 4, Sweden
Basel , 4031, Switzerland
Bern , 3010, Switzerland
North Dist. , 70403, Taiwan
Taichung , 407, Taiwan
Taipei , 100, Taiwan
Taoyuan , 333, Taiwan
Adana , 01060, Turkey
Ankara , 06490, Turkey
Istanbul , , Turkey
Glasgow , G12 0, United Kingdom
London , EC1A , United Kingdom
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