RecruitingRecruiting
Combination Therapies With Adagrasib in Patients With Advanced NSCLC With KRAS G12C Mutation
NCT05609578 · Mirati Therapeutics Inc.
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Official title
A Phase 2 Trial of Combination Therapies With Adagrasib in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation
About this study
Study CA239-0010 is an open-label, Phase 2 clinical trial evaluating the clinical efficacy of adagrasib in combination with pembrolizumab and chemotherapy in the first-line setting for patients with advanced NSCLC with TPS ≥ 1%, TPS \<50% and KRAS G12C mutation
Eligibility criteria
Cohort A\* (closed): Has an untreated and unresectable or metastatic NSCLC with histologically confirmed (squamous or nonsquamous) KRASG12C mutation and histologically confirmed PD-L1 TPS ≥1%.
* Cohort C: Has an untreated and unresectable or metastatic NSCLC with histologically confirmed (non-squamous only) KRASG12C mutation and histologically confirmed PD-L1 TPS \< 50% AND previously completed 4 cycles of standard-of-care platinum based induction chemotherapy with pembrolizumab AND experienced stable disease, partial response, or complete response per investigator's assessment after 4 cycles OR if patients received \<4 cycles of a platinum-based induction, was stopped early due to intolerable toxicity
* Cohort E: Has an untreated and unresectable or metastatic NSCLC with histologically confirmed (non-squamous only) KRASG12C mutation and histologically confirmed PD-L1 TPS \< 50%
* Presence of measurable disease per RECIST v1.1
Exclusion Criteria:
* All Cohorts: Any prior therapy targeting KRASG12C mutation in any setting
* 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
Study design
Enrollment target: 90 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2022-11-22
Estimated completion: 2026-12-01
Last updated: 2025-08-17
Interventions
Drug: Adagrasib oral dose of 400 mg twice daily tabletsCombination Product: PembrolizumabCombination Product: Chemotherapy: PemetrexedCombination Product: Cisplatin/Carboplatin
Primary outcomes
- • Objective Response Rate (ORR) for Cohort A and E (30 months)
- • Progression-free Survival (PFS) at six months for Cohort C (30 months)
Sponsor
Mirati Therapeutics Inc. · industry
Contacts & investigators
ContactBMS Clinical Trials Contact Center www.BMSClinicalTrials.com · contact · Clinical.Trials@bms.com · 855-907-3286
ContactFirst line of the email MUST contain the NCT# and Site #. · contact
InvestigatorBristol-Myers Squibb · study_director, Bristol-Myers Squibb
All locations (166)
Local Institution - Unk025Active Not Recruiting
Anchorage, Alaska, United States
Local Institution - 017-591Withdrawn
Glendale, Arizona, United States
Local Institution - 017-821Withdrawn
Phoenix, Arizona, United States
Local Institution - Unk047Active Not Recruiting
Anaheim, California, United States
Local Institution - 017-936CNot Yet Recruiting
Fountain Valley, California, United States
MemorialCare - Orange Coast Medical CenterRecruiting
Fountain Valley, California, United States
Providence Medical Foundation - Virginia K. Crosson Cancer Center - FullertonRecruiting
Fullerton, California, United States
Local Institution - Unk004Active Not Recruiting
Loma Linda, California, United States
Local Institution - 017-961Withdrawn
Los Angeles, California, United States
UCSF Helen Diller Family Comprehensive Cancer CenterRecruiting
San Francisco, California, United States
Local Institution - 017-872-INot Yet Recruiting
Aurora, Colorado, United States
Local Institution - 017-872-GNot Yet Recruiting
Boulder, Colorado, United States
Local Institution - 017-872-DNot Yet Recruiting
Colorado Springs, Colorado, United States
Local Institution - 017-872-JNot Yet Recruiting
Colorado Springs, Colorado, United States
Local Institution - 017-872-BNot Yet Recruiting
Denver, Colorado, United States
Local Institution - 017-872-FNot Yet Recruiting
Denver, Colorado, United States
Local Institution - 017-872-ANot Yet Recruiting
Lakewood, Colorado, United States
Local Institution - 017-872-CNot Yet Recruiting
Littleton, Colorado, United States
USOR - Rocky Mountain Cancer Centers - Lone Tree - Sky Ridge Medical CenterRecruiting
Lone Tree, Colorado, United States
Local Institution - 017-872-ENot Yet Recruiting
Pueblo, Colorado, United States
Local Institution - 017-872-HNot Yet Recruiting
Thornton, Colorado, United States
Mayo Clinic - JacksonvilleRecruiting
Jacksonville, Florida, United States
The Oncology Institute of Hope and Innovation - LakelandRecruiting
Lakeland, Florida, United States
Local Institution - Unk076Active Not Recruiting
Miami, Florida, United States
Local Institution - Unk055Active Not Recruiting
Orlando, Florida, United States
Local Institution - Unk062Active Not Recruiting
Chicago, Illinois, United States
University of ChicagoRecruiting
Chicago, Illinois, United States
Local Institution - 017-820JNot Yet Recruiting
Fairway, Kansas, United States
Local Institution - 017-820ANot Yet Recruiting
Kansas City, Kansas, United States
Local Institution - 017-820BNot Yet Recruiting
Kansas City, Kansas, United States
Local Institution - 017-820CNot Yet Recruiting
Kansas City, Kansas, United States
Local Institution - 017-820HNot Yet Recruiting
Kansas City, Kansas, United States
Local Institution - 017-820INot Yet Recruiting
Overland Park, Kansas, United States
University of Kansas Cancer Center - Westwood/Richard and Annette Bloch Cancer Care PavilionRecruiting
Westwood, Kansas, United States
Local Institution - 017-965Withdrawn
Lexington, Kentucky, United States
Local Institution - Unk009Active Not Recruiting
Baltimore, Maryland, United States
Beth Israel Deaconess Medical CenterRecruiting
Boston, Massachusetts, United States
Dana-Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Local Institution - Unk039Active Not Recruiting
Burlington, Massachusetts, United States
Local Institution - Unk069Active Not Recruiting
Detroit, Michigan, United States
Local Institution - Unk018Active Not Recruiting
Lansing, Michigan, United States
Henry Ford Medical Center - ColumbusRecruiting
Novi, Michigan, United States
Local Institution - 017-838BNot Yet Recruiting
Minneapolis, Minnesota, United States
Local Institution - 017-838CNot Yet Recruiting
Minneapolis, Minnesota, United States
Mayo Clinic - RochesterRecruiting
Rochester, Minnesota, United States
Metro-Minnesota Community Oncology Research Consortium (MMCORC)Recruiting
Saint Louis Park, Minnesota, United States
Local Institution - 017-838ANot Yet Recruiting
Saint Louis Park, Minnesota, United States
Local Institution - 017-820FNot Yet Recruiting
Kansas City, Missouri, United States
Local Institution - 017-820ENot Yet Recruiting
Kansas City, Missouri, United States
Local Institution - 017-820DNot Yet Recruiting
Lee's Summit, Missouri, United States
Local Institution - 017-820GNot Yet Recruiting
North Kansas City, Missouri, United States
Local Institution - Unk008Active Not Recruiting
Osage Beach, Missouri, United States
Local Institution - Unk058Active Not Recruiting
Springfield, Missouri, United States
Local Institution - 017-080Not Yet Recruiting
Babylon, New York, United States
Local Institution - 017-088Not Yet Recruiting
Brooklyn, New York, United States
Hematology-Oncology Associates of Central New York - Brittonfield - East SyracuseRecruiting
East Syracuse, New York, United States
Local Institution - 017-087Not Yet Recruiting
New Hyde Park, New York, United States
Local Institution - 017-085Not Yet Recruiting
New York, New York, United States
Local Institution - 017-082Not Yet Recruiting
Patchogue, New York, United States
Local Institution - 017-086Not Yet Recruiting
Port Jefferson, New York, United States
Local Institution - 017-081Not Yet Recruiting
Port Jefferson Station, New York, United States
New York Cancer & Blood Specialists - Cancer Center - Research HeadquartersRecruiting
Port Jefferson Station, New York, United States
Local Institution - 017-084Not Yet Recruiting
Riverhead, New York, United States
Local Institution - 017-945Withdrawn
The Bronx, New York, United States
Local Institution - 017-083Not Yet Recruiting
The Bronx, New York, United States
Cleveland Clinic Main CampusRecruiting
Cleveland, Ohio, United States
Local Institution - 017-836Withdrawn
Kettering, Ohio, United States
Local Institution - 017-916Withdrawn
Memphis, Tennessee, United States
Texas Oncology - Dallas Fort Worth (DFW) - Baylor Charles A. Sammons Cancer CenterRecruiting
Dallas, Texas, United States
Local Institution - Unk056Active Not Recruiting
Dallas, Texas, United States
Local Institution - 017-848Withdrawn
Houston, Texas, United States
Local Institution - 017-999Not Yet Recruiting
Irving, Texas, United States
USOR - Texas Oncology Northeast Texas - Longview Cancer CenterRecruiting
Longview, Texas, United States
Local Institution - 017-878-BNot Yet Recruiting
Palestine, Texas, United States
Local Institution - 017-878-CNot Yet Recruiting
Paris, Texas, United States
Local Institution - 017-878-ANot Yet Recruiting
Tyler, Texas, United States
Local Institution - Unk010Active Not Recruiting
Salt Lake City, Utah, United States
Local Institution - 017-814-ANot Yet Recruiting
Arlington, Virginia, United States
Local Institution - Unk066Active Not Recruiting
Fairfax, Virginia, United States
Virginia Cancer Specialists - Fairfax OfficeRecruiting
Fairfax, Virginia, United States
Local Institution - 017-814-BNot Yet Recruiting
Gainesville, Virginia, United States
Local Institution - 017-814-CNot Yet Recruiting
Reston, Virginia, United States
PeaceHealth St. Joseph Medical CenterRecruiting
Bellingham, Washington, United States
Local Institution - Unk036Active Not Recruiting
Huntington, West Virginia, United States
Local Institution - 017-458Withdrawn
Natal, Rio Grande do Norte, Brazil
Local Institution - 017-446Withdrawn
Ijuí, Rio Grande do Sul, Brazil
Local Institution - 017-453Withdrawn
Itajaí, Santa Catarina, Brazil
Local Institution - 017-457Withdrawn
Barretos, Brazil
Local Institution - 017-442Withdrawn
Curitiba, Brazil
Local Institution - 017-452Withdrawn
Fortaleza, Brazil
Local Institution - 017-455Withdrawn
Jaú, Brazil
Local Institution - 017-454Withdrawn
Rio de Janeiro, Brazil
Local Institution - 017-456Withdrawn
São Paulo, Brazil
Local Institution - 017-695Withdrawn
Viña del Mar, Valparaiso, Chile
Local Institution - 017-697Withdrawn
Providencia, Chile
Local Institution - 017-696Withdrawn
Santiago, Chile
Local Institution - 017-698Withdrawn
Temuco, Chile
Institut de Cancerologie de lOuest - AngersRecruiting
Angers, France
Centre Francois BaclesseRecruiting
Caen, France
Centre Hospitalier Intercommunal de CreteilRecruiting
Créteil, France
Centre Georges Francois LeclercRecruiting
Dijon, France
Hopital MichallonRecruiting
La Tronche, France
Local Institution - 017-688Withdrawn
Lille, France
Local Institution - Unk078Active Not Recruiting
Lyon, France
Institut Paoli-CalmettesRecruiting
Marseille, France
Local Institution - Unk067Active Not Recruiting
Marseille, France
Local Institution - 017-200Withdrawn
Montpellier, France
Local Institution - Unk029Active Not Recruiting
Paris, France
Hopital TenonRecruiting
Paris, France
Local Institution - 017-664Withdrawn
Paris, France
Local Institution - 017-198Withdrawn
Saint-Herblain, France
Hopital FochRecruiting
Suresnes, France
Hopital LarreyRecruiting
Toulouse, France
Gustave RoussyRecruiting
Villejuif, France
Local Institution - 017-790Withdrawn
Batumi, Georgia
Local Institution - 017-789Withdrawn
Tbilisi, Georgia
Local Institution - 017-794Withdrawn
Tbilisi, Georgia
Local Institution - 017-791Withdrawn
Tbilisi, Georgia
Local Institution - 017-792Withdrawn
Tbilisi, Georgia
Local Institution - 017-793Withdrawn
Tbilisi, Georgia
University General Hospital of Heraklion (PAGNI)Recruiting
Heraklion, Greece
University General Hospital of LarissaRecruiting
Larissa, Greece
Metropolitan HospitalRecruiting
Piraeus, Greece
Orszagos Koranyi Pulmonologiai IntezetRecruiting
Budapest, Hungary
Orszagos Onkologiai IntezetRecruiting
Budapest, Hungary
Fejer Varmegyei Szent Gyorgy Egyetemi Oktato KorhazRecruiting
Székesfehérvár, Hungary
Reformatus Pulmonologiai CentrumRecruiting
Törökbálint, Hungary
Local Institution - 017-767 - BNot Yet Recruiting
Faenza, Ravenna, Italy
Local Institution - 017-767 - ANot Yet Recruiting
Lugo, Ravenna, Italy
Azienda Ospedaliera San Giuseppe Moscati - AvellinoRecruiting
Avellino, Italy
Local Institution - 017-274Not Yet Recruiting
Aviano, Italy
Ospedale Santo SpiritoRecruiting
Casale Monferrato, Italy
Azienda Ospedaliero - Universitaria CareggiRecruiting
Florence, Italy
Istituto Europeo di OncologiaRecruiting
Milan, Italy
Azienda Ospedaliero - Universitaria San Luigi GonzagaRecruiting
Orbassano, Italy
Local Institution - 017-297Withdrawn
Padova, Italy
Ospedale Santa Maria delle Croci di RavennaRecruiting
Ravenna, Italy
IRCCS Istituto Nazionale Tumori Regina ElenaRecruiting
Roma, Italy
Local Institution - 017-280Active Not Recruiting
Roma, Italy
Local Institution - 017-076Withdrawn
Kota Bharu, Kelantan, Malaysia
Local Institution - 017-075Withdrawn
Kuantan, Pahang, Malaysia
Local Institution - 017-073Withdrawn
Kuala Lumpur, Malaysia
Local Institution - 017-072Withdrawn
Putrajaya, Malaysia
Local Institution - 017-381Withdrawn
Konin, Poland
Instytut MSFRecruiting
Lodz, Poland
Med Polonia Sp. z o. o. - ObornickaRecruiting
Poznan, Poland
Wojskowy Instytut MedycznyRecruiting
Warsaw, Poland
Local Institution - 017-692Withdrawn
Belgrade, Serbia
Local Institution - 017-693Withdrawn
Belgrade, Serbia
Local Institution - 017-690Withdrawn
Belgrade, Serbia
Local Institution - 017-691Withdrawn
Kamenitz, Serbia
Local Institution - 017-694Withdrawn
Kragujevac, Serbia
Complejo Hospitalario Universitario A CorunaRecruiting
A Coruña, Spain
Hospital General Universitario Gregorio MaranonRecruiting
Madrid, Spain
Hospital Universitario La PazRecruiting
Madrid, Spain
Hospital Universitario Puerta de Hierro - MajadahondaRecruiting
Majadahonda, Spain
Local Institution - Unk001Active Not Recruiting
Málaga, Spain
Hospital Universitario Son EspasesRecruiting
Palma de Mallorca, Spain
Hospital Son LlatzerRecruiting
Palma de Mallorca, Spain
Hospital Universitario Virgen MacarenaRecruiting
Seville, Spain
Hospital Clinico Universitario Lozano BlesaRecruiting
Zaragoza, Spain
Local Institution - 017-395Withdrawn
Geneva, Switzerland
Local Institution - 017-132Withdrawn
Bang Phlat, Thailand
Local Institution - 017-136Withdrawn
Bangkok, Thailand
Local Institution - 017-135Withdrawn
Chom Thong, Thailand
Local Institution - 017-137Withdrawn
Khon Kaen, Thailand