Combination Therapies With Adagrasib in Patients With Advanced NSCLC With KRAS G12C Mutation
NCT ID: NCT05609578
Last Updated: 2025-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
90 participants
INTERVENTIONAL
2022-11-22
2026-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Cohort A: PD-L1 TPS≥ 1% (Closed)
Adagrasib 400 mg BID for 2 cycles followed by adagrasib 400 mg BID + pembrolizumab 200 mg every 3 weeks (Q3W) up to 35 cycles
Adagrasib oral dose of 400 mg twice daily tablets
oral dose of 400 mg twice daily tablets
Cohort C
Adagrasib 400 mg BID + pemetrexed 500 mg/m2 Q3W + pembrolizumab 200 mg Q3W up to 31 cycles
Adagrasib oral dose of 400 mg twice daily tablets
oral dose of 400 mg twice daily tablets
Pembrolizumab
IV infusion once every 3 weeks
Chemotherapy: Pemetrexed
IV infusion once every 3 weeks
Cisplatin/Carboplatin
IV infusion once every 3 weeks
Cohort E
Adagrasib 400 mg BID + pembrolizumab 200 mg Q3W + pemetrexed 500 mg/m2 + cisplatin 75 mg/m2 Q3W OR carboplatin AUC 5 Q3W for 4 cycles, followed by adagrasib 400 mg BID + pemetrexed 500 mg/m2 Q3W + pembrolizumab 200 mg Q3W (up to 31 cycles)
Adagrasib oral dose of 400 mg twice daily tablets
oral dose of 400 mg twice daily tablets
Pembrolizumab
IV infusion once every 3 weeks
Chemotherapy: Pemetrexed
IV infusion once every 3 weeks
Cisplatin/Carboplatin
IV infusion once every 3 weeks
Interventions
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Adagrasib oral dose of 400 mg twice daily tablets
oral dose of 400 mg twice daily tablets
Pembrolizumab
IV infusion once every 3 weeks
Chemotherapy: Pemetrexed
IV infusion once every 3 weeks
Cisplatin/Carboplatin
IV infusion once every 3 weeks
Eligibility Criteria
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Exclusion Criteria
* Cohorts A \& E: Prior systemic therapy for locally advanced or metastatic NSCLC, including chemotherapy, immune checkpoint inhibitor therapy or chemoimmunotherapy (note: prior systemic therapy or chemoradiation given in the adjuvant or neoadjuvant setting are allowed if last dose of prior systemic treatment was \>1 year prior to first dose of study treatment)
* Cohort C: received maintenance therapy (e.g, pembrolizumab and/or pemetrexed following completion of 4-6 cycles of a platinum-based regimen administered in the first-line setting
* Radiation to the lung \> 30 Gy within 6 months prior to first dose of study treatment
* Active brain metastases
18 Years
ALL
No
Sponsors
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Mirati Therapeutics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Centre Georges Francois Leclerc
Dijon, , France
Hopital Michallon
La Tronche, , France
Local Institution - 017-688
Lille, , France
Local Institution - Unk025
Anchorage, Alaska, United States
Local Institution - 017-591
Glendale, Arizona, United States
Local Institution - 017-821
Phoenix, Arizona, United States
Local Institution - Unk047
Anaheim, California, United States
Local Institution - 017-936C
Fountain Valley, California, United States
MemorialCare - Orange Coast Medical Center
Fountain Valley, California, United States
Providence Medical Foundation - Virginia K. Crosson Cancer Center - Fullerton
Fullerton, California, United States
Local Institution - Unk004
Loma Linda, California, United States
Local Institution - 017-961
Los Angeles, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Local Institution - 017-872-I
Aurora, Colorado, United States
Local Institution - 017-872-G
Boulder, Colorado, United States
Local Institution - 017-872-D
Colorado Springs, Colorado, United States
Local Institution - 017-872-J
Colorado Springs, Colorado, United States
Local Institution - 017-872-B
Denver, Colorado, United States
Local Institution - 017-872-F
Denver, Colorado, United States
Local Institution - 017-872-A
Lakewood, Colorado, United States
Local Institution - 017-872-C
Littleton, Colorado, United States
USOR - Rocky Mountain Cancer Centers - Lone Tree - Sky Ridge Medical Center
Lone Tree, Colorado, United States
Local Institution - 017-872-E
Pueblo, Colorado, United States
Local Institution - 017-872-H
Thornton, Colorado, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States
The Oncology Institute of Hope and Innovation - Lakeland
Lakeland, Florida, United States
Local Institution - Unk076
Miami, Florida, United States
Local Institution - Unk055
Orlando, Florida, United States
Local Institution - Unk062
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Local Institution - 017-820J
Fairway, Kansas, United States
Local Institution - 017-820A
Kansas City, Kansas, United States
Local Institution - 017-820B
Kansas City, Kansas, United States
Local Institution - 017-820C
Kansas City, Kansas, United States
Local Institution - 017-820H
Kansas City, Kansas, United States
Local Institution - 017-820I
Overland Park, Kansas, United States
University of Kansas Cancer Center - Westwood/Richard and Annette Bloch Cancer Care Pavilion
Westwood, Kansas, United States
Local Institution - 017-965
Lexington, Kentucky, United States
Local Institution - Unk009
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Local Institution - Unk039
Burlington, Massachusetts, United States
Local Institution - Unk069
Detroit, Michigan, United States
Local Institution - Unk018
Lansing, Michigan, United States
Henry Ford Medical Center - Columbus
Novi, Michigan, United States
Local Institution - 017-838B
Minneapolis, Minnesota, United States
Local Institution - 017-838C
Minneapolis, Minnesota, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Metro-Minnesota Community Oncology Research Consortium (MMCORC)
Saint Louis Park, Minnesota, United States
Local Institution - 017-838A
Saint Louis Park, Minnesota, United States
Local Institution - 017-820F
Kansas City, Missouri, United States
Local Institution - 017-820E
Kansas City, Missouri, United States
Local Institution - 017-820D
Lee's Summit, Missouri, United States
Local Institution - 017-820G
North Kansas City, Missouri, United States
Local Institution - Unk008
Osage Beach, Missouri, United States
Local Institution - Unk058
Springfield, Missouri, United States
Local Institution - 017-080
Babylon, New York, United States
Local Institution - 017-088
Brooklyn, New York, United States
Hematology-Oncology Associates of Central New York - Brittonfield - East Syracuse
East Syracuse, New York, United States
Local Institution - 017-087
New Hyde Park, New York, United States
Local Institution - 017-085
New York, New York, United States
Local Institution - 017-082
Patchogue, New York, United States
Local Institution - 017-086
Port Jefferson, New York, United States
Local Institution - 017-081
Port Jefferson Station, New York, United States
New York Cancer & Blood Specialists - Cancer Center - Research Headquarters
Port Jefferson Station, New York, United States
Local Institution - 017-084
Riverhead, New York, United States
Local Institution - 017-945
The Bronx, New York, United States
Local Institution - 017-083
The Bronx, New York, United States
Cleveland Clinic Main Campus
Cleveland, Ohio, United States
Local Institution - 017-836
Kettering, Ohio, United States
Local Institution - 017-916
Memphis, Tennessee, United States
Texas Oncology - Dallas Fort Worth (DFW) - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
Local Institution - Unk056
Dallas, Texas, United States
Local Institution - 017-848
Houston, Texas, United States
Local Institution - 017-999
Irving, Texas, United States
USOR - Texas Oncology Northeast Texas - Longview Cancer Center
Longview, Texas, United States
Local Institution - 017-878-B
Palestine, Texas, United States
Local Institution - 017-878-C
Paris, Texas, United States
Local Institution - 017-878-A
Tyler, Texas, United States
Local Institution - Unk010
Salt Lake City, Utah, United States
Local Institution - 017-814-A
Arlington, Virginia, United States
Local Institution - Unk066
Fairfax, Virginia, United States
Virginia Cancer Specialists - Fairfax Office
Fairfax, Virginia, United States
Local Institution - 017-814-B
Gainesville, Virginia, United States
Local Institution - 017-814-C
Reston, Virginia, United States
PeaceHealth St. Joseph Medical Center
Bellingham, Washington, United States
Local Institution - Unk036
Huntington, West Virginia, United States
Local Institution - 017-458
Natal, Rio Grande do Norte, Brazil
Local Institution - 017-446
Ijuí, Rio Grande do Sul, Brazil
Local Institution - 017-453
Itajaí, Santa Catarina, Brazil
Local Institution - 017-457
Barretos, , Brazil
Local Institution - 017-442
Curitiba, , Brazil
Local Institution - 017-452
Fortaleza, , Brazil
Local Institution - 017-455
Jaú, , Brazil
Local Institution - 017-454
Rio de Janeiro, , Brazil
Local Institution - 017-456
São Paulo, , Brazil
Local Institution - 017-695
Viña del Mar, Región de Valparaíso, Chile
Local Institution - 017-697
Providencia, , Chile
Local Institution - 017-696
Santiago, , Chile
Local Institution - 017-698
Temuco, , Chile
Institut de Cancerologie de lOuest - Angers
Angers, , France
Centre Francois Baclesse
Caen, , France
Centre Hospitalier Intercommunal de Creteil
Créteil, , France
Local Institution - Unk078
Lyon, , France
Institut Paoli-Calmettes
Marseille, , France
Local Institution - Unk067
Marseille, , France
Local Institution - 017-200
Montpellier, , France
Local Institution - Unk029
Paris, , France
Hopital Tenon
Paris, , France
Local Institution - 017-664
Paris, , France
Local Institution - 017-198
Saint-Herblain, , France
Hopital Foch
Suresnes, , France
Hopital Larrey
Toulouse, , France
Gustave Roussy
Villejuif, , France
Local Institution - 017-790
Batumi, , Georgia
Local Institution - 017-789
Tbilisi, , Georgia
Local Institution - 017-794
Tbilisi, , Georgia
Local Institution - 017-791
Tbilisi, , Georgia
Local Institution - 017-792
Tbilisi, , Georgia
Local Institution - 017-793
Tbilisi, , Georgia
University General Hospital of Heraklion (PAGNI)
Heraklion, , Greece
University General Hospital of Larissa
Larissa, , Greece
Metropolitan Hospital
Piraeus, , Greece
Orszagos Koranyi Pulmonologiai Intezet
Budapest, , Hungary
Orszagos Onkologiai Intezet
Budapest, , Hungary
Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár, , Hungary
Reformatus Pulmonologiai Centrum
Törökbálint, , Hungary
Local Institution - 017-767 - B
Faenza, Ravenna, Italy
Local Institution - 017-767 - A
Lugo, Ravenna, Italy
Azienda Ospedaliera San Giuseppe Moscati - Avellino
Avellino, , Italy
Local Institution - 017-274
Aviano, , Italy
Ospedale Santo Spirito
Casale Monferrato, , Italy
Azienda Ospedaliero - Universitaria Careggi
Florence, , Italy
Istituto Europeo di Oncologia
Milan, , Italy
Azienda Ospedaliero - Universitaria San Luigi Gonzaga
Orbassano, , Italy
Local Institution - 017-297
Padua, , Italy
Ospedale Santa Maria delle Croci di Ravenna
Ravenna, , Italy
IRCCS Istituto Nazionale Tumori Regina Elena
Roma, , Italy
Local Institution - 017-280
Roma, , Italy
Local Institution - 017-076
Kota Bharu, Kelantan, Malaysia
Local Institution - 017-075
Kuantan, Pahang, Malaysia
Local Institution - 017-073
Kuala Lumpur, , Malaysia
Local Institution - 017-072
Putrajaya, , Malaysia
Local Institution - 017-381
Konin, , Poland
Instytut MSF
Lodz, , Poland
Med Polonia Sp. z o. o. - Obornicka
Poznan, , Poland
Wojskowy Instytut Medyczny
Warsaw, , Poland
Local Institution - 017-692
Belgrade, , Serbia
Local Institution - 017-693
Belgrade, , Serbia
Local Institution - 017-690
Belgrade, , Serbia
Local Institution - 017-691
Kamenitz, , Serbia
Local Institution - 017-694
Kragujevac, , Serbia
Complejo Hospitalario Universitario A Coruna
A Coruña, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda, , Spain
Local Institution - Unk001
Málaga, , Spain
Hospital Universitario Son Espases
Palma de Mallorca, , Spain
Hospital Son Llatzer
Palma de Mallorca, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Clinico Universitario Lozano Blesa
Zaragoza, , Spain
Local Institution - 017-395
Geneva, , Switzerland
Local Institution - 017-132
Bang Phlat, , Thailand
Local Institution - 017-136
Bangkok, , Thailand
Local Institution - 017-135
Chom Thong, , Thailand
Local Institution - 017-137
Khon Kaen, , Thailand
Countries
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Central Contacts
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BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Role: CONTACT
First line of the email MUST contain the NCT# and Site #.
Role: CONTACT
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Site 017-936C
Role: primary
Amol Rao, Site 017-936
Role: primary
David Park, Site 017-851
Role: primary
Collin Blakely, Site 017-540
Role: primary
Site 017-872-I
Role: primary
Site 017-872-G
Role: primary
Site 017-872-D
Role: primary
Site 017-872-J
Role: primary
Site 017-872-B
Role: primary
Site 017-872-F
Role: primary
Site 017-872-A
Role: primary
Site 017-872-C
Role: primary
Robert Jotte, Site 017-872
Role: primary
Site 017-872-E
Role: primary
Site 017-872-H
Role: primary
Yan Yan Lou, Site 017-829
Role: primary
Kamal Sharma, Site 017-898
Role: primary
Marina Garassino, Site 017-972
Role: primary
Site 017-820J
Role: primary
Site 017-820A
Role: primary
Site 017-820B
Role: primary
Site 017-820C
Role: primary
Site 017-820H
Role: primary
Site 017-820I
Role: primary
Jun Zhang, Site 017-820
Role: primary
Daniel Costa, Site 017-388
Role: primary
Pasi Janne, Site 017-808
Role: primary
Shirish Gadgeel, Site 017-811
Role: primary
Site 017-838B
Role: primary
Site 017-838C
Role: primary
Konstantinos Leventakos, Site 017-830
Role: primary
Yan Ji, Site 017-838
Role: primary
Site 017-838A
Role: primary
Site 017-820F
Role: primary
Site 017-820E
Role: primary
Site 017-820D
Role: primary
Site 017-820G
Role: primary
Site 017-080
Role: primary
Site 017-088
Role: primary
Ajeet Gajra, Site 017-587
Role: primary
Site 017-087
Role: primary
Site 017-085
Role: primary
Site 017-082
Role: primary
Site 017-086
Role: primary
Site 017-081
Role: primary
Richard Zuniga, Site 017-535
Role: primary
Site 017-084
Role: primary
Site 017-083
Role: primary
Nathan Pennell, Site 017-818
Role: primary
Kartik Konduri, Site 017-879
Role: primary
Site 017-999
Role: primary
Donald Richards, Site 017-878
Role: primary
Site 017-878-B
Role: primary
Site 017-878-C
Role: primary
Site 017-878-A
Role: primary
Site 017-814-A
Role: primary
Alexander Spira, Site 017-814
Role: primary
Site 017-814-B
Role: primary
Site 017-814-C
Role: primary
Drew Murray, Site 017-909
Role: primary
Frederic Bigot, Site 017-689
Role: primary
Hubert CURCIO, Site 017-196
Role: primary
Christos Chouaid, Site 017-190
Role: primary
Coureche Kaderbhai, Site 017-192
Role: primary
Denis Moro-Sibilot, Site 017-683
Role: primary
Anne Madroszyk-Flandin, Site 017-199
Role: primary
Jacques Cadranel, Site 017-686
Role: primary
Jaafar Bennouma, Site 017-667
Role: primary
Julien Mazieres, Site 017-663
Role: primary
Fabrice Barlesi, Site 017-202
Role: primary
Dimitrios Mavroudis, Site 017-238
Role: primary
Athanasios Kotsakis, Site 017-235
Role: primary
Helena Linardou, Site 017-234
Role: primary
Andrea Fulop, Site 017-244
Role: primary
Tunde Nagy, Site 017-241
Role: primary
Zsolt Papai-Szekely, Site 017-759
Role: primary
Gabriella Galffy, Site 017-240
Role: primary
Site 017-767 - B
Role: primary
Site 017-767 - A
Role: primary
Assunta Sgambato, Site 017-292
Role: primary
Site 017-274
Role: primary
Roberta Buosi, Site 017-773
Role: primary
Lorenzo Antonuzzo, Site 017-762
Role: primary
Filippo de Marinis, Site 017-278
Role: primary
Silvia Novello, Site 017-788
Role: primary
Manolo DArcangelo, Site 017-767
Role: primary
Federico Capuzzo, Site 017-295
Role: primary
Ewa Kalinka, Site 017-757
Role: primary
Rodryg Ramlau, Site 017-382
Role: primary
Renata Duchnowska, Site 017-774
Role: primary
Maria Rosario Garcia Campelo, Site 017-613
Role: primary
Antonio Calles Blanco, Site 017-619
Role: primary
Javier De Castro Carpeno, Site 017-624
Role: primary
Mariano Provencio Pulla, Site 017-626
Role: primary
Aitor Azkarate, Site 017-602
Role: primary
Juan Coves Sarto, Site 017-771
Role: primary
David Baz, Site 017-772
Role: primary
Dolores Isla Casado, Site 017-603
Role: primary
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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849-017
Identifier Type: OTHER
Identifier Source: secondary_id
CA239-0010
Identifier Type: OTHER
Identifier Source: secondary_id
CA239-0010
Identifier Type: -
Identifier Source: org_study_id
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