A Phase 2 Trial of Combination Therapies With Adagrasib in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation
Status: Recruiting
Location: See all (166) locations...
Intervention Type: Drug, Combination product
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ 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
Locations
United States
Alaska
Local Institution - Unk025
ACTIVE_NOT_RECRUITING
Anchorage
Arizona
Local Institution - 017-591
WITHDRAWN
Glendale
Local Institution - 017-821
WITHDRAWN
Phoenix
California
Local Institution - Unk047
ACTIVE_NOT_RECRUITING
Anaheim
Local Institution - 017-936C
NOT_YET_RECRUITING
Fountain Valley
MemorialCare - Orange Coast Medical Center
RECRUITING
Fountain Valley
Providence Medical Foundation - Virginia K. Crosson Cancer Center - Fullerton
RECRUITING
Fullerton
Local Institution - Unk004
ACTIVE_NOT_RECRUITING
Loma Linda
Local Institution - 017-961
WITHDRAWN
Los Angeles
UCSF Helen Diller Family Comprehensive Cancer Center
RECRUITING
San Francisco
Colorado
Local Institution - 017-872-I
NOT_YET_RECRUITING
Aurora
Local Institution - 017-872-G
NOT_YET_RECRUITING
Boulder
Local Institution - 017-872-D
NOT_YET_RECRUITING
Colorado Springs
Local Institution - 017-872-J
NOT_YET_RECRUITING
Colorado Springs
Local Institution - 017-872-B
NOT_YET_RECRUITING
Denver
Local Institution - 017-872-F
NOT_YET_RECRUITING
Denver
Local Institution - 017-872-A
NOT_YET_RECRUITING
Lakewood
Local Institution - 017-872-C
NOT_YET_RECRUITING
Littleton
USOR - Rocky Mountain Cancer Centers - Lone Tree - Sky Ridge Medical Center
RECRUITING
Lone Tree
Local Institution - 017-872-E
NOT_YET_RECRUITING
Pueblo
Local Institution - 017-872-H
NOT_YET_RECRUITING
Thornton
Florida
Mayo Clinic - Jacksonville
RECRUITING
Jacksonville
The Oncology Institute of Hope and Innovation - Lakeland
RECRUITING
Lakeland
Local Institution - Unk076
ACTIVE_NOT_RECRUITING
Miami
Local Institution - Unk055
ACTIVE_NOT_RECRUITING
Orlando
Illinois
Local Institution - Unk062
ACTIVE_NOT_RECRUITING
Chicago
University of Chicago
RECRUITING
Chicago
Kansas
Local Institution - 017-820J
NOT_YET_RECRUITING
Fairway
Local Institution - 017-820A
NOT_YET_RECRUITING
Kansas City
Local Institution - 017-820B
NOT_YET_RECRUITING
Kansas City
Local Institution - 017-820C
NOT_YET_RECRUITING
Kansas City
Local Institution - 017-820H
NOT_YET_RECRUITING
Kansas City
Local Institution - 017-820I
NOT_YET_RECRUITING
Overland Park
University of Kansas Cancer Center - Westwood/Richard and Annette Bloch Cancer Care Pavilion
RECRUITING
Westwood
Kentucky
Local Institution - 017-965
WITHDRAWN
Lexington
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Dana-Farber Cancer Institute
RECRUITING
Boston
Local Institution - Unk039
ACTIVE_NOT_RECRUITING
Burlington
Maryland
Local Institution - Unk009
ACTIVE_NOT_RECRUITING
Baltimore
Michigan
Local Institution - Unk069
ACTIVE_NOT_RECRUITING
Detroit
Local Institution - Unk018
ACTIVE_NOT_RECRUITING
Lansing
Henry Ford Medical Center - Columbus
RECRUITING
Novi
Minnesota
Local Institution - 017-838B
NOT_YET_RECRUITING
Minneapolis
Local Institution - 017-838C
NOT_YET_RECRUITING
Minneapolis
Mayo Clinic - Rochester
RECRUITING
Rochester
Local Institution - 017-838A
NOT_YET_RECRUITING
Saint Louis Park
Metro-Minnesota Community Oncology Research Consortium (MMCORC)
RECRUITING
Saint Louis Park
Missouri
Local Institution - 017-820E
NOT_YET_RECRUITING
Kansas City
Local Institution - 017-820F
NOT_YET_RECRUITING
Kansas City
Local Institution - 017-820D
NOT_YET_RECRUITING
Lee's Summit
Local Institution - 017-820G
NOT_YET_RECRUITING
North Kansas City
Local Institution - Unk008
ACTIVE_NOT_RECRUITING
Osage Beach
Local Institution - Unk058
ACTIVE_NOT_RECRUITING
Springfield
New York
Local Institution - 017-080
NOT_YET_RECRUITING
Babylon
Local Institution - 017-088
NOT_YET_RECRUITING
Brooklyn
Hematology-Oncology Associates of Central New York - Brittonfield - East Syracuse
RECRUITING
East Syracuse
Local Institution - 017-087
NOT_YET_RECRUITING
New Hyde Park
Local Institution - 017-085
NOT_YET_RECRUITING
New York
Local Institution - 017-082
NOT_YET_RECRUITING
Patchogue
Local Institution - 017-086
NOT_YET_RECRUITING
Port Jefferson
Local Institution - 017-081
NOT_YET_RECRUITING
Port Jefferson Station
New York Cancer & Blood Specialists - Cancer Center - Research Headquarters
RECRUITING
Port Jefferson Station
Local Institution - 017-084
NOT_YET_RECRUITING
Riverhead
Local Institution - 017-083
NOT_YET_RECRUITING
The Bronx
Local Institution - 017-945
WITHDRAWN
The Bronx
Ohio
Cleveland Clinic Main Campus
RECRUITING
Cleveland
Local Institution - 017-836
WITHDRAWN
Kettering
Tennessee
Local Institution - 017-916
WITHDRAWN
Memphis
Texas
Local Institution - Unk056
ACTIVE_NOT_RECRUITING
Dallas
Texas Oncology - Dallas Fort Worth (DFW) - Baylor Charles A. Sammons Cancer Center
RECRUITING
Dallas
Local Institution - 017-848
WITHDRAWN
Houston
Local Institution - 017-999
NOT_YET_RECRUITING
Irving
USOR - Texas Oncology Northeast Texas - Longview Cancer Center
RECRUITING
Longview
Local Institution - 017-878-B
NOT_YET_RECRUITING
Palestine
Local Institution - 017-878-C
NOT_YET_RECRUITING
Paris
Local Institution - 017-878-A
NOT_YET_RECRUITING
Tyler
Utah
Local Institution - Unk010
ACTIVE_NOT_RECRUITING
Salt Lake City
Virginia
Local Institution - 017-814-A
NOT_YET_RECRUITING
Arlington
Local Institution - Unk066
ACTIVE_NOT_RECRUITING
Fairfax
Virginia Cancer Specialists - Fairfax Office
RECRUITING
Fairfax
Local Institution - 017-814-B
NOT_YET_RECRUITING
Gainesville
Local Institution - 017-814-C
NOT_YET_RECRUITING
Reston
Washington
PeaceHealth St. Joseph Medical Center
RECRUITING
Bellingham
West Virginia
Local Institution - Unk036
ACTIVE_NOT_RECRUITING
Huntington
Other Locations
Brazil
Local Institution - 017-457
WITHDRAWN
Barretos
Local Institution - 017-442
WITHDRAWN
Curitiba
Local Institution - 017-452
WITHDRAWN
Fortaleza
Local Institution - 017-446
WITHDRAWN
Ijuí
Local Institution - 017-453
WITHDRAWN
Itajaí
Local Institution - 017-455
WITHDRAWN
Jaú
Local Institution - 017-458
WITHDRAWN
Natal
Local Institution - 017-454
WITHDRAWN
Rio De Janeiro
Local Institution - 017-456
WITHDRAWN
São Paulo
Chile
Local Institution - 017-697
WITHDRAWN
Providencia
Local Institution - 017-696
WITHDRAWN
Santiago
Local Institution - 017-698
WITHDRAWN
Temuco
Local Institution - 017-695
WITHDRAWN
Viña Del Mar
France
Institut de Cancerologie de lOuest - Angers
RECRUITING
Angers
Centre Francois Baclesse
RECRUITING
Caen
Centre Hospitalier Intercommunal de Creteil
RECRUITING
Créteil
Centre Georges Francois Leclerc
RECRUITING
Dijon
Hopital Michallon
RECRUITING
La Tronche
Local Institution - 017-688
WITHDRAWN
Lille
Local Institution - Unk078
ACTIVE_NOT_RECRUITING
Lyon
Institut Paoli-Calmettes
RECRUITING
Marseille
Local Institution - Unk067
ACTIVE_NOT_RECRUITING
Marseille
Local Institution - 017-200
WITHDRAWN
Montpellier
Hopital Tenon
RECRUITING
Paris
Local Institution - 017-664
WITHDRAWN
Paris
Local Institution - Unk029
ACTIVE_NOT_RECRUITING
Paris
Local Institution - 017-198
WITHDRAWN
Saint-herblain
Hopital Foch
RECRUITING
Suresnes
Hopital Larrey
RECRUITING
Toulouse
Gustave Roussy
RECRUITING
Villejuif
Georgia
Local Institution - 017-790
WITHDRAWN
Batumi
Local Institution - 017-789
WITHDRAWN
Tbilisi
Local Institution - 017-791
WITHDRAWN
Tbilisi
Local Institution - 017-792
WITHDRAWN
Tbilisi
Local Institution - 017-793
WITHDRAWN
Tbilisi
Local Institution - 017-794
WITHDRAWN
Tbilisi
Greece
University General Hospital of Heraklion (PAGNI)
RECRUITING
Heraklion
University General Hospital of Larissa
RECRUITING
Larissa
Metropolitan Hospital
RECRUITING
Piraeus
Hungary
Orszagos Koranyi Pulmonologiai Intezet
RECRUITING
Budapest
Orszagos Onkologiai Intezet
RECRUITING
Budapest
Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz
RECRUITING
Székesfehérvár
Reformatus Pulmonologiai Centrum
RECRUITING
Törökbálint
Italy
Azienda Ospedaliera San Giuseppe Moscati - Avellino
RECRUITING
Avellino
Local Institution - 017-274
NOT_YET_RECRUITING
Aviano
Ospedale Santo Spirito
RECRUITING
Casale Monferrato
Local Institution - 017-767 - B
NOT_YET_RECRUITING
Faenza
Azienda Ospedaliero - Universitaria Careggi
RECRUITING
Florence
Local Institution - 017-767 - A
NOT_YET_RECRUITING
Lugo
Istituto Europeo di Oncologia
RECRUITING
Milan
Azienda Ospedaliero - Universitaria San Luigi Gonzaga
RECRUITING
Orbassano
Local Institution - 017-297
WITHDRAWN
Padua
Ospedale Santa Maria delle Croci di Ravenna
RECRUITING
Ravenna
IRCCS Istituto Nazionale Tumori Regina Elena
RECRUITING
Roma
Local Institution - 017-280
ACTIVE_NOT_RECRUITING
Roma
Malaysia
Local Institution - 017-076
WITHDRAWN
Kota Bharu
Local Institution - 017-073
WITHDRAWN
Kuala Lumpur
Local Institution - 017-075
WITHDRAWN
Kuantan
Local Institution - 017-072
WITHDRAWN
Putrajaya
Poland
Local Institution - 017-381
WITHDRAWN
Konin
Instytut MSF
RECRUITING
Lodz
Med Polonia Sp. z o. o. - Obornicka
RECRUITING
Poznan
Wojskowy Instytut Medyczny
RECRUITING
Warsaw
Serbia
Local Institution - 017-690
WITHDRAWN
Belgrade
Local Institution - 017-692
WITHDRAWN
Belgrade
Local Institution - 017-693
WITHDRAWN
Belgrade
Local Institution - 017-691
WITHDRAWN
Kamenitz
Local Institution - 017-694
WITHDRAWN
Kragujevac
Spain
Complejo Hospitalario Universitario A Coruna
RECRUITING
A Coruña
Hospital General Universitario Gregorio Maranon
RECRUITING
Madrid
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Universitario Puerta de Hierro - Majadahonda
RECRUITING
Majadahonda
Local Institution - Unk001
ACTIVE_NOT_RECRUITING
Málaga
Hospital Son Llatzer
RECRUITING
Palma De Mallorca
Hospital Universitario Son Espases
RECRUITING
Palma De Mallorca
Hospital Universitario Virgen Macarena
RECRUITING
Seville
Hospital Clinico Universitario Lozano Blesa
RECRUITING
Zaragoza
Switzerland
Local Institution - 017-395
WITHDRAWN
Geneva
Thailand
Local Institution - 017-132
WITHDRAWN
Bang Phlat
Local Institution - 017-136
WITHDRAWN
Bangkok
Local Institution - 017-135
WITHDRAWN
Chom Thong
Local Institution - 017-137
WITHDRAWN
Khon Kaen
Contact Information
Primary
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Clinical.Trials@bms.com
855-907-3286
Backup
First line of the email MUST contain the NCT# and Site #.
Time Frame
Start Date: 2022-11-22
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 90
Treatments
Experimental: 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
Experimental: Cohort C
Adagrasib 400 mg BID + pemetrexed 500 mg/m2 Q3W + pembrolizumab 200 mg Q3W up to 31 cycles
Experimental: 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)
Related Therapeutic Areas
Sponsors
Leads: Mirati Therapeutics Inc.