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).

View Eligibility Criteria

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

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

96

Study ID:

NCT05789082

Recruitment Status:

Recruiting

Sponsor:

Hoffmann-La Roche

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There are 48 Locations for this study

See Locations Near You

Yale Cancer Center
New Haven Connecticut, 06520, United States
NYU Langone Hospital - Long Island
Mineola New York, 11501, United States
NYU Cancer Center; NYU Cancer Institute
New York New York, 10016, United States
Hospital Britanico; Oncologia
Buenos Aires , C1280, Argentina
Clinica Adventista Belgrano; Oncology
Ciudad Autonoma Buenos Aires , C1430, Argentina
Centro Oncologico Riojano Integral (CORI)
La Rioja , F5300, Argentina
Concord Repatriation General Hospital; Concord Cancer Centre
Concord New South Wales, 2139, Australia
Alfred Health
Melbourne Victoria, 3004, Australia
Cliniques Universitaires St-Luc
Bruxelles , 1200, Belgium
Jessa Zkh (Campus Virga Jesse)
Hasselt , 3500, Belgium
Clinique Ste-Elisabeth
Namur , 5000, Belgium
AZ Delta (Campus Rumbeke)
Roeselare , 8800, Belgium
Hospital Nossa Senhora da Conceicao
Porto Alegre RS, 90040, Brazil
Hospital de Cancer de Barretos
Barretos SP, 14784, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
Sao Paulo SP, 01246, Brazil
Princess Margaret Cancer Center
Toronto Ontario, M5G 1, Canada
Jewish General Hospital
Montreal Quebec, H3T 1, Canada
Harbin Medical University Cancer Hospital
Harbin , 15008, China
Shanghai Pulmonary Hospital
Shanghai , 20043, China
Rambam Medical Center; Oncology
Haifa , 31096, Israel
Rabin MC; Davidof Center - Oncology Institute
Petach Tikva , 49414, Israel
Tel Aviv Sourasky Medical Ctr; Oncology
Tel Aviv , 64239, Israel
Istituto Nazionale Tumori Fondazione G. Pascale
Napoli Campania, 80131, Italy
Policlinico Universitario Agostino Gemelli IRCCS; UOS Fase 1
Roma Lazio, 00168, Italy
A.O. UNIVERSITARIA S. LUIGI GONZAGA; Oncologia Medica
Orbassano Piemonte, 10043, Italy
Pusan National University Hospital
Busan , 602-7, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Korea University Guro Hospital
Seoul , 08308, Korea, Republic of
NKI The Netherlands Cancer Institute
Amsterdam , 1066 , Netherlands
UMC St Radboud
Nijmegen , 6525 , Netherlands
Uniwersyteckie Centrum Kliniczne; Osrodek Badan Wczesnych Faz
Gda?sk , 80-21, Poland
Krakowski Szpital Specjalistyczny im sw. Jana Paw?a II; Oddzia? Onkologiczny
Kraków , 31-20, Poland
Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii
Olsztyn , 10-35, Poland
ICO Badalona-H.U. Germans Trias i Pujol
Badalona Barcelona, 08916, Spain
NEXT Oncology-Hospital Quironsalud Madrid
Pozuelo de Alarcon Madrid, 28223, Spain
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
Barcelona , 08035, Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Madrid , 28007, Spain
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
Sevilla , 41013, Spain
Sahlgrenska University Hospital; Sahlgrenska Clinical Trial unit / Department of Oncology
Göteborg , 413 4, Sweden
Universitätsspital Basel; Oncology - Klinische Forschung
Basel , 4031, Switzerland
Inselspital Bern; Universitätsklinik für Medizinische Onkologie, Klinische Forschungseinheit
Bern , 3010, Switzerland
National Cheng Kung University Hospital; Internal Medicine
North Dist. , 70403, Taiwan
National Taiwan Uni Hospital; Internal Medicine
Taipei , 100, Taiwan
Chang Gung Medical Foundation - Linkou; Chest Dept
Taoyuan , 333, Taiwan
Adana City Hospital, Medical Oncology
Adana , 01060, Turkey
Ankara Bilkent City Hospital
Ankara , 06490, Turkey
Koc University Hospital; Oncology
Istanbul , , Turkey
Beatson West of Scotland Cancer Centre
Glasgow , G12 0, United Kingdom
Barts & London School of Med; Medical Oncology
London , EC1A , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

96

Study ID:

NCT05789082

Recruitment Status:

Recruiting

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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