Phase
Condition
Non-small Cell Lung Cancer
Treatment
Pembrolizumab
GDC-6036
Pemetrexed
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Confirmation of Biomarker eligibility
Pre-treatment tumor tissue along with an associated pathology report is required forall participants enrolled on study. Representative tumor specimens must be informalin-fixed, paraffin embedded (FFPE) blocks (preferred) or 15 unstained, freshlycut, serial slides. Although 15 slides are required, if only 10 slides areavailable, the participant may be eligible for the study following consultation withthe Sponsor.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
Histologically or cytologically documented locally advanced unresectable ormetastatic NSCLC that is not eligible for curative surgery and/or definitivechemoradiotherapy
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
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; orknown hypersensitivity to pemetrexed, carboplatin, or cisplatin (Cohort B only)
History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitisobliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence ofactive pneumonitis, active tuberculosis, significant cardiovascular disease within 3months prior to initiation of study treatment
History of malignancy other than NSCLC within 5 years prior to initiation of studytreatment, with the exception of malignancies with a negligible risk of metastasisor death (e.g., 5-year OS rate more >90%), such as adequately treated carcinoma insitu of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductalbreast carcinoma in situ, or Stage I uterine cancer
Uncontrolled tumor related pain, pleural effusion, pericardial effusion, or ascitesrequiring recurrent drainage procedures, uncontrolled or symptomatic hypercalcemia
Study Design
Connect with a study center
Hospital Britanico
Buenos Aires, C1280AEB
ArgentinaActive - Recruiting
Hospital Britanico; Oncologia
Buenos Aires, C1280AEB
ArgentinaActive - Recruiting
Clinica Adventista Belgrano
Ciudad Autonoma Buenos Aires, C1430EGF
ArgentinaActive - Recruiting
Clinica Adventista Belgrano; Oncology
Ciudad Autonoma Buenos Aires, C1430EGF
ArgentinaActive - Recruiting
Centro Oncologico Riojano Integral (CORI)
La Rioja, F5300COE
ArgentinaActive - Recruiting
Concord Repatriation General Hospital
Concord, New South Wales 2139
AustraliaActive - Recruiting
Concord Repatriation General Hospital; Concord Cancer Centre
Concord, New South Wales 2139
AustraliaActive - Recruiting
Alfred Health
Melbourne, Victoria 3004
AustraliaActive - Recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria 3000
AustraliaActive - Recruiting
Peter MacCallum Cancer Centre; Medical Oncology
Melbourne, Victoria 3000
AustraliaActive - Recruiting
Cliniques Universitaires St-Luc
Bruxelles, 1200
BelgiumActive - Recruiting
Jessa Zkh (Campus Virga Jesse)
Hasselt, 3500
BelgiumActive - Recruiting
Clinique Ste-Elisabeth
Namur, 5000
BelgiumActive - Recruiting
AZ Delta (Campus Rumbeke)
Roeselare, 8800
BelgiumActive - Recruiting
Crio - Centro Regional Integrado de Oncologia
Fortaleza, CE 60336-232
BrazilSite Not Available
Hospital Nossa Senhora da Conceicao
Porto Alegre, RS 90040-373
BrazilSite Not Available
Hospital de Cancer de Barretos
Barretos, São Paulo 14784-400
BrazilActive - Recruiting
Instituto do Cancer do Estado de Sao Paulo - ICESP
Sao Paulo, São Paulo 01246-000
BrazilActive - Recruiting
Princess Margaret Cancer Center
Toronto, Ontario M5G 1Z5
CanadaSite Not Available
Jewish General Hospital
Montreal, Quebec H3T 1E2
CanadaActive - Recruiting
Hunan Cancer Hospital
Changsha CITY, 410013
ChinaSite Not Available
Harbin Medical University Cancer Hospital
Harbin, 150081
ChinaSite Not Available
Shanghai Pulmonary Hospital
Shanghai, 200433
ChinaSite Not Available
Rambam Medical Center
Haifa, 3109601
IsraelActive - Recruiting
Rambam Medical Center; Oncology
Haifa, 3109601
IsraelActive - Recruiting
Rabin MC
Petach Tikva, 4941492
IsraelActive - Recruiting
Rabin MC; Davidof Center - Oncology Institute
Petach Tikva, 4941492
IsraelActive - Recruiting
Tel Aviv Sourasky Medical Ctr
Tel Aviv, 6423906
IsraelActive - Recruiting
Tel Aviv Sourasky Medical Ctr; Oncology
Tel Aviv, 6423906
IsraelActive - Recruiting
Istituto Nazionale Tumori Fondazione G. Pascale
Napoli, Campania 80131
ItalyActive - Recruiting
Policlinico Universitario Agostino Gemelli IRCCS
Roma, Lazio 00168
ItalySite Not Available
Policlinico Universitario Agostino Gemelli IRCCS; UOS Fase 1
Roma, Lazio 00168
ItalyActive - Recruiting
Irccs Istituto Nazionale Dei Tumori (Int)
Milano, Lombardia 20133
ItalyActive - Recruiting
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1
Milano, Lombardia 20133
ItalyActive - Recruiting
A.O. UNIVERSITARIA S. LUIGI GONZAGA; Oncologia Medica
Orbassano, Piemonte 10043
ItalyActive - Recruiting
A.O. Universitaria S. Luigi Gonzaga
Orbassano, Piemonte 10043
ItalyActive - Recruiting
Pusan National University Hospital
Busan, 49241
Korea, Republic ofActive - Recruiting
Asan Medical Center
Seoul, 05505
Korea, Republic ofActive - Recruiting
Korea University Guro Hospital
Seoul, 08308
Korea, Republic ofActive - Recruiting
Samsung Medical Center
Seoul, 06351
Korea, Republic ofActive - Recruiting
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofActive - Recruiting
NKI The Netherlands Cancer Institute
Amsterdam, 1066 CX
NetherlandsSite Not Available
UMC St Radboud
Nijmegen, 6525 GA
NetherlandsActive - Recruiting
Uniwersyteckie Centrum Kliniczne
Gda?sk, 80-214
PolandActive - Recruiting
Uniwersyteckie Centrum Kliniczne; Osrodek Badan Wczesnych Faz
Gda?sk, 80-214
PolandActive - Recruiting
Krakowski Szpital Specjalistyczny im sw. Jana Paw?a II
Kraków, 31-202
PolandActive - Recruiting
Krakowski Szpital Specjalistyczny im sw. Jana Paw?a II; Oddzia? Onkologiczny
Kraków, 31-202
PolandActive - Recruiting
Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie
Olsztyn, 10-357
PolandSite Not Available
Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii
Olsztyn, 10-357
PolandActive - Recruiting
ICO Badalona-H.U. Germans Trias i Pujol
Badalona, Barcelona 08916
SpainActive - Recruiting
NEXT Oncology-Hospital Quironsalud Madrid
Pozuelo de Alarcon, Madrid 28223
SpainSite Not Available
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, 08035
SpainActive - Recruiting
Hospital General Universitario Gregorio Marañon
Madrid, 28007
SpainActive - Recruiting
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Madrid, 28009
SpainActive - Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
SpainActive - Recruiting
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid, 28041
SpainActive - Recruiting
Hospital Universitario Virgen del Rocio
Sevilla, 41013
SpainActive - Recruiting
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
Sevilla, 41013
SpainActive - Recruiting
Hospital Clinico Universitario de Valencia
Valencia, 46010
SpainSite Not Available
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
Valencia, 46010
SpainActive - Recruiting
Sahlgrenska University Hospital
Göteborg, 411 36
SwedenActive - Recruiting
Sahlgrenska University Hospital; Sahlgrenska Clinical Trial unit / Department of Oncology
Göteborg, 413 45
SwedenActive - Recruiting
Universitätsspital Basel
Basel, 4031
SwitzerlandSite Not Available
Universitätsspital Basel; Oncology - Klinische Forschung
Basel, 4031
SwitzerlandSite Not Available
Inselspital Bern
Bern, 3010
SwitzerlandActive - Recruiting
Inselspital Bern; Universitätsklinik für Medizinische Onkologie, Klinische Forschungseinheit
Bern, 3010
SwitzerlandActive - Recruiting
Inselspital Bern; Universitätsklinik für medizinische Onkologie
Bern, 3010
SwitzerlandActive - Recruiting
National Cheng Kung University Hospital; Internal Medicine
North Dist., 70403
TaiwanSite Not Available
Taichung Veterans General Hospital
Taichung, 407
TaiwanActive - Recruiting
Taichung Veterans General Hospital; Dept of Internal Medicine
Taichung, 407
TaiwanActive - Recruiting
National Cheng Kung University Hospital
Tainan,
TaiwanActive - Recruiting
National Taiwan Uni Hospital
Taipei, 100
TaiwanActive - Recruiting
National Taiwan Uni Hospital; Internal Medicine
Taipei, 100
TaiwanActive - Recruiting
Chang Gung Medical Foundation - Linkou
Taoyuan, 333
TaiwanSite Not Available
Chang Gung Medical Foundation - Linkou; Chest Dept
Taoyuan, 333
TaiwanSite Not Available
Adana City Hospital, Medical Oncology
Adana, 01060
TurkeySite Not Available
Ankara Bilkent City Hospital
Ankara, 06490
TurkeySite Not Available
Koc University Hospital; Oncology
Istanbul,
TurkeySite Not Available
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN
United KingdomActive - Recruiting
Barts & London School of Med
London, EC1A 7BE
United KingdomActive - Recruiting
Barts & London School of Med; Medical Oncology
London, EC1A 7BE
United KingdomActive - Recruiting
City of Hope National Medical Center
Duarte, California 91010
United StatesActive - Recruiting
City of Hope - Seacliff
Huntington Beach, California 92648
United StatesActive - Recruiting
City of Hope at Irvine Lennar
Irvine, California 92618
United StatesActive - Recruiting
UCSD Moores Cancer Center
La Jolla, California 92093
United StatesActive - Recruiting
Yale Cancer Center
New Haven, Connecticut 06520
United StatesActive - Recruiting
NYU Langone Hospital - Long Island
Mineola, New York 11501
United StatesActive - Recruiting
Mount SInai Medical Center
New York, New York 10029
United StatesActive - Recruiting
NYU Cancer Center
New York, New York 10016
United StatesActive - Recruiting
NYU Cancer Center; NYU Cancer Institute
New York, New York 10016
United StatesActive - Recruiting
MD Anderson Cancer Center
Houston, Texas 77030
United StatesActive - Recruiting
MD Anderson Cancer Center; Oncology
Houston, Texas 77030
United StatesActive - Recruiting
Oncology & Hematology Associates of Southwest Virginia, Inc
Blacksburg, Virginia 24060
United StatesActive - Recruiting
Virginia Oncology Associates
Norfolk, Virginia 23502
United StatesActive - Recruiting
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