Phase
Condition
Non-small Cell Lung Cancer
Treatment
Pembrolizumab
Pemetrexed
GDC-6036
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. Additionally, for participants in cohort D, measurable brainmetastases defined as at least 5 millimeters and twice the slice thickness, but lessthan 20 mm, that is asymptomatic and does not require local therapy at the time ofenrollment.
Exclusion
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; 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
Co-morbid condition that is an absolute contraindication to treatment withcorticosteroids
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 isclinically appropriate
Study Design
Connect with a study center
Hospital Britanico
Buenos Aires, C1280AEB
ArgentinaActive - Recruiting
Hospital Britanico; Oncologia
Buenos Aires, C1280AEB
ArgentinaActive - Recruiting
Hospital Britanico
Buenos Aires 3435910, C1280AEB
ArgentinaSite Not Available
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
Centro Oncologico Riojano Integral (CORI)
La Rioja 3848950, F5300COE
ArgentinaSite Not Available
Concord Repatriation General Hospital
Concord, New South Wales 2139
AustraliaCompleted
Concord Repatriation General Hospital; Concord Cancer Centre
Concord, New South Wales 2139
AustraliaActive - Recruiting
Concord Repatriation General Hospital
Concord 2170852, New South Wales 2155400 2139
AustraliaSite Not Available
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
Alfred Health
Melbourne 2158177, Victoria 2145234 3004
AustraliaActive - Recruiting
Peter MacCallum Cancer Centre
Melbourne 2158177, Victoria 2145234 3000
AustraliaSite Not Available
Cliniques Universitaires St-Luc
Brussels, 1200
BelgiumActive - Recruiting
Cliniques Universitaires St-Luc
Brussels 2800866, 1200
BelgiumSite Not Available
Cliniques Universitaires St-Luc
Bruxelles, 1200
BelgiumSite Not Available
Jessa Zkh (Campus Virga Jesse)
Hasselt, 3500
BelgiumActive - Recruiting
Jessa Zkh (Campus Virga Jesse)
Hasselt 2796491, 3500
BelgiumSite Not Available
Clinique Ste-Elisabeth
Namur, 5000
BelgiumActive - Recruiting
Clinique Ste-Elisabeth
Namur 2790471, 5000
BelgiumSite Not Available
AZ Delta (Campus Rumbeke)
Roeselare, 8800
BelgiumActive - Recruiting
AZ Delta (Campus Rumbeke)
Roeselare 2787889, 8800
BelgiumSite Not Available
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
BrazilSite Not Available
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, São Paulo 01246-000
BrazilActive - Recruiting
Hospital de Cancer de Barretos
Barretos 3470451, São Paulo 3448433 14784-400
BrazilSite Not Available
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo 3448439, São Paulo 3448433 01246-000
BrazilSite Not Available
Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario K1H 8M2
CanadaActive - Recruiting
Princess Margaret Cancer Center
Toronto, Ontario M5G 1Z5
CanadaSite Not Available
Ottawa Hospital Regional Cancer Centre
Ottawa 6094817, Ontario 6093943 K1H 8M2
CanadaSite Not Available
Princess Margaret Cancer Center
Toronto 6167865, Ontario 6093943 M5G 1Z5
CanadaSite Not Available
Jewish General Hospital
Montreal, Quebec H3T 1E2
CanadaActive - Recruiting
Jewish General Hospital
Montreal 6077243, Quebec 6115047 H3T 1E2
CanadaSite Not Available
Hunan Cancer Hospital
Changsha, 410013
ChinaSite Not Available
Hunan Cancer Hospital
Changsha 1815577, 410013
ChinaSite Not Available
Hunan Cancer Hospital
Changsha CITY, 410013
ChinaSite Not Available
Harbin Medical University Cancer Hospital
Harbin, 150081
ChinaActive - Recruiting
Harbin Medical University Cancer Hospital
Harbin 2037013, 150081
ChinaSite Not Available
Shanghai Pulmonary Hospital
Shanghai, 200433
ChinaSite Not Available
Shanghai Pulmonary Hospital
Shanghai 1796236, 200433
ChinaSite Not Available
Rambam Medical Center
Haifa, 3109601
IsraelActive - Recruiting
Rambam Medical Center; Oncology
Haifa, 3109601
IsraelActive - Recruiting
Rambam Medical Center
Haifa 294801, 3109601
IsraelSite Not Available
Rabin MC
Petach Tikva, 4941492
IsraelSite Not Available
Rabin MC; Davidof Center - Oncology Institute
Petach Tikva, 4941492
IsraelActive - Recruiting
Rabin MC
Petah Tikva, 4941492
IsraelActive - Recruiting
Rabin MC
Petah Tikva 293918, 4941492
IsraelSite Not Available
Tel Aviv Sourasky Medical Ctr
Tel Aviv, 6423906
IsraelActive - Recruiting
Tel Aviv Sourasky Medical Ctr; Oncology
Tel Aviv, 6423906
IsraelActive - Recruiting
Tel Aviv Sourasky Medical Ctr
Tel Aviv 293397, 6423906
IsraelSite Not Available
Istituto Nazionale Tumori Fondazione G. Pascale
Naples, Campania 80131
ItalySite Not Available
Istituto Nazionale Tumori Fondazione G. Pascale
Napoli, Campania 80131
ItalySite Not Available
Istituto Nazionale Tumori Fondazione G. Pascale
Napoli 9031661, Campania 3181042 80131
ItalySite Not Available
Policlinico Universitario Agostino Gemelli IRCCS
Roma, Lazio 00168
ItalySite Not Available
Policlinico Universitario Agostino Gemelli IRCCS; UOS Fase 1
Roma, Lazio 00168
ItalyActive - Recruiting
Policlinico Universitario Agostino Gemelli IRCCS
Rome, Lazio 00168
ItalySite Not Available
Policlinico Universitario Agostino Gemelli IRCCS
Rome 3169070, Lazio 3174976 00168
ItalySite Not Available
Irccs Istituto Nazionale Dei Tumori (Int)
Milano, Lombardia 20133
ItalySite Not Available
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1
Milano, Lombardia 20133
ItalyActive - Recruiting
Irccs Istituto Nazionale Dei Tumori (Int)
Milan, Lombardy 20133
ItalyActive - Recruiting
Irccs Istituto Nazionale Dei Tumori (Int)
Milan 3173435, Lombardy 3174618 20133
ItalySite Not Available
A.O. Universitaria S. Luigi Gonzaga
Orbassano, Piedmont 10043
ItalyActive - Recruiting
A.O. Universitaria S. Luigi Gonzaga
Orbassano 3171986, Piedmont 3170831 10043
ItalySite Not Available
A.O. UNIVERSITARIA S. LUIGI GONZAGA; Oncologia Medica
Orbassano, Piemonte 10043
ItalyActive - Recruiting
National Cancer Center Hospital East
Chiba, 277-8577
JapanActive - Recruiting
National Cancer Center Hospital East
Chiba 2113015, 277-8577
JapanSite Not Available
Kindai University Hospital
Osaka, 589-8511
JapanActive - Recruiting
Kindai University Hospital
Osaka 1853909, 589-8511
JapanSite Not Available
National Cancer Center Hospital
Tokyo, 104-0045
JapanActive - Recruiting
The Cancer Institute Hospital of JFCR
Tokyo, 135-8550
JapanActive - Recruiting
National Cancer Center Hospital
Tokyo 1850147, 104-0045
JapanSite Not Available
The Cancer Institute Hospital of JFCR
Tokyo 1850147, 135-8550
JapanActive - Recruiting
Wakayama Medical University Hospital
Wakayama, 641-8510
JapanActive - Recruiting
Wakayama Medical University Hospital
Wakayama 1926004, 641-8510
JapanSite Not Available
Pusan National University Hospital
Busan, 49241
Korea, Republic ofSite Not Available
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 ofSite Not Available
NKI The Netherlands Cancer Institute
Amsterdam, 1066 CX
NetherlandsSite Not Available
NKI The Netherlands Cancer Institute
Amsterdam 2759794, 1066 CX
NetherlandsSite Not Available
UMC St Radboud
Nijmegen, 6525 GA
NetherlandsActive - Recruiting
UMC St Radboud
Nijmegen 2750053, 6525 GA
NetherlandsSite Not Available
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
Krakow, 31-202
PolandActive - Recruiting
Krakowski Szpital Specjalistyczny im sw. Jana Paw?a II
Krakow 3094802, 31-202
PolandSite Not Available
Krakowski Szpital Specjalistyczny im sw. Jana Paw?a II
Kraków, 31-202
PolandSite Not Available
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
Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie
Olsztyn 763166, 10-357
PolandSite Not Available
Pusan National University Hospital
Busan, 49241
South KoreaActive - Recruiting
Pusan National University Hospital
Busan 1838524, 49241
South KoreaSite Not Available
Asan Medical Center
Seoul, 05505
South KoreaActive - Recruiting
Korea University Guro Hospital
Seoul, 08308
South KoreaActive - Recruiting
Samsung Medical Center
Seoul, 06351
South KoreaActive - Recruiting
Seoul National University Hospital
Seoul, 03080
South KoreaActive - Recruiting
Asan Medical Center
Seoul 1835848, 05505
South KoreaActive - Recruiting
Korea University Guro Hospital
Seoul 1835848, 08308
South KoreaActive - Recruiting
Samsung Medical Center
Seoul 1835848, 06351
South KoreaActive - Recruiting
Seoul National University Hospital
Seoul 1835848, 03080
South KoreaSite Not Available
ICO Badalona-H.U. Germans Trias i Pujol
Badalona, Barcelona 08916
SpainActive - Recruiting
ICO Badalona-H.U. Germans Trias i Pujol
Badalona 3129028, Barcelona 08916
SpainSite Not Available
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
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
Barcelona 3128760, 08035
SpainSite Not Available
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 General Universitario Gregorio Marañon
Madrid 3117735, 28007
SpainSite Not Available
Hospital Universitario 12 de Octubre
Madrid 3117735, 28041
SpainActive - Recruiting
Hospital Universitario Virgen del Rocio
Sevilla, 41013
SpainSite Not Available
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
Sevilla, 41013
SpainActive - Recruiting
Hospital Universitario Virgen del Rocio
Seville, 41013
SpainActive - Recruiting
Hospital Universitario Virgen del Rocio
Seville 2510911, 41013
SpainSite Not Available
Hospital Clinico Universitario de Valencia
Valencia, 46010
SpainActive - Recruiting
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
Valencia, 46010
SpainActive - Recruiting
Hospital Clinico Universitario de Valencia
Valencia 2509954, 46010
SpainSite Not Available
Sahlgrenska University Hospital
Gothenburg, 411 36
SwedenActive - Recruiting
Sahlgrenska University Hospital
Gothenburg 2711537, 411 36
SwedenSite Not Available
Sahlgrenska University Hospital
Göteborg, 411 36
SwedenSite Not Available
Sahlgrenska University Hospital; Sahlgrenska Clinical Trial unit / Department of Oncology
Göteborg, 413 45
SwedenActive - Recruiting
Universitätsspital Basel
Basel, 4031
SwitzerlandActive - Recruiting
Universitätsspital Basel; Oncology - Klinische Forschung
Basel, 4031
SwitzerlandSite Not Available
Universitätsspital Basel
Basel 2661604, 4031
SwitzerlandSite Not Available
Inselspital Bern
Bern, 3010
SwitzerlandSite Not Available
Inselspital Bern; Universitätsklinik für Medizinische Onkologie, Klinische Forschungseinheit
Bern, 3010
SwitzerlandActive - Recruiting
Inselspital Bern; Universitätsklinik für medizinische Onkologie
Bern, 3010
SwitzerlandActive - Recruiting
Inselspital Bern
Bern 2661552, 3010
SwitzerlandSite Not Available
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
Taichung Veterans General Hospital
Taichung 1668399, 407
TaiwanSite Not Available
National Cheng Kung University Hospital
Tainan,
TaiwanActive - Recruiting
National Cheng Kung University Hospital
Tainan 1668355,
TaiwanSite Not Available
National Cheng Kung University Hospital
Tainan City 1668355,
TaiwanSite Not Available
National Taiwan Uni Hospital
Taipei, 100
TaiwanActive - Recruiting
National Taiwan Uni Hospital; Internal Medicine
Taipei, 100
TaiwanActive - Recruiting
National Taiwan Uni Hospital
Taipei 1668341, 100
TaiwanSite Not Available
Chang Gung Medical Foundation - Linkou
Taoyuan, 333
TaiwanSite Not Available
Chang Gung Medical Foundation - Linkou; Chest Dept
Taoyuan, 333
TaiwanSite Not Available
Chang Gung Medical Foundation - Linkou
Taoyuan District, 333
TaiwanSite Not Available
Chang Gung Medical Foundation - Linkou
Taoyuan District 1667905, 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
Beatson West of Scotland Cancer Centre
Glasgow 2648579, G12 0YN
United KingdomSite Not Available
Barts & London School of Med
London, EC1A 7BE
United KingdomActive - Recruiting
Barts & London School of Med; Medical Oncology
London, EC1A 7BE
United KingdomActive - Recruiting
Barts & London School of Med
London 2643743, EC1A 7BE
United KingdomSite Not Available
City of Hope National Medical Center
Duarte, California 91010
United StatesSite Not Available
City of Hope - Seacliff
Huntington Beach, California 92648
United StatesSite Not Available
City of Hope at Irvine Lennar
Irvine, California 92618
United StatesSite Not Available
UCSD Moores Cancer Center
La Jolla, California 92093
United StatesSite Not Available
City of Hope - Long Beach Elm
Long Beach, California 90813
United StatesSite Not Available
City of Hope National Medical Center
Duarte 5344147, California 5332921 91010
United StatesSite Not Available
City of Hope - Seacliff
Huntington Beach 5358705, California 5332921 92648
United StatesSite Not Available
City of Hope at Irvine Lennar
Irvine 5359777, California 5332921 92618
United StatesSite Not Available
UCSD Moores Cancer Center
La Jolla 5363943, California 5332921 92093
United StatesSite Not Available
City of Hope - Long Beach Elm
Long Beach 5367929, California 5332921 90813
United StatesSite Not Available
Yale Cancer Center
New Haven, Connecticut 06520
United StatesActive - Recruiting
Yale Cancer Center
New Haven 4839366, Connecticut 4831725 06520
United StatesSite Not Available
Florida Cancer Specialists - SOUTH - SCRI - PPDS
Fort Myers, Florida 33901-8108
United StatesActive - Recruiting
Florida Cancer Specialists - NORTH - SCRI - PPDS
St. Petersburg, Florida 33705-1400
United StatesActive - Recruiting
Florida Cancer Specialists - EAST - SCRI - PPDS
West Palm Beach, Florida 33401-3406
United StatesActive - Recruiting
Florida Cancer Specialists - SOUTH - SCRI - PPDS
Fort Myers 4155995, Florida 4155751 33901-8108
United StatesSite Not Available
Florida Cancer Specialists - NORTH - SCRI - PPDS
St. Petersburg 4171563, Florida 4155751 33705-1400
United StatesSite Not Available
Florida Cancer Specialists - EAST - SCRI - PPDS
West Palm Beach 4177887, Florida 4155751 33401-3406
United StatesSite Not Available
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
Montefiore Medical Center - Montefiore Medical Park
The Bronx, New York 10461
United StatesActive - Recruiting
NYU Langone Hospital - Long Island
Mineola 5127134, New York 5128638 11501
United StatesSite Not Available
Mount SInai Medical Center
New York 5128581, New York 5128638 10029
United StatesSite Not Available
NYU Cancer Center
New York 5128581, New York 5128638 10016
United StatesActive - Recruiting
Montefiore Medical Center - Montefiore Medical Park
The Bronx 5110266, New York 5128638 10461
United StatesSite Not Available
MD Anderson Cancer Center
Houston, Texas 77030
United StatesActive - Recruiting
MD Anderson Cancer Center; Oncology
Houston, Texas 77030
United StatesActive - Recruiting
MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available
Oncology & Hematology Associates of Southwest Virginia, Inc
Blacksburg, Virginia 24060
United StatesActive - Recruiting
Virginia Oncology Associates
Norfolk, Virginia 23502
United StatesActive - Recruiting
Oncology & Hematology Associates of Southwest Virginia, Inc
Blacksburg 4747845, Virginia 6254928 24060
United StatesSite Not Available
Virginia Oncology Associates
Norfolk 4776222, Virginia 6254928 23502
United StatesSite Not Available

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