Lung Cancer Clinical Trial
Phase 2 Trial of MRTX849 Monotherapy and in Combination With Pembrolizumab for NSCLC With KRAS G12C Mutation KRYSTAL-7
Summary
This Phase 2 study evaluates the efficacy and safety of MRTX849 monotherapy and in combination with pembrolizumab in cohorts of patients with advanced NSCLC with KRAS G12C mutation and any PD-L1 TPS and who are candidates for first-line treatment.
Full Description
This Phase 2 study will evaluate the efficacy and safety of MRTX849 as monotherapy and in combination with pembrolizumab. There will be 3 cohorts of patients, all of whom have KRAS G12C mutation, have advanced or metastatic NSCLC, and are candidates for first-line treatment. 2 cohorts have PDL-1 TPS score <1% and are randomized to MRTX849 monotherapy or MRTX849 in combination with pembrolizumab. The 3rd cohort has PDL-1 TPS score of 1% or higher and is treated with MRTX849 and pembrolizumab
MRTX849 is an orally available small molecule inhibitor of KRAS G12C, and Pembrolizumab (KEYTRUDA®) is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2.
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed diagnosis of NSCLC (squamous or nonsquamous) with KRAS G12C mutation and known PD-L1 Tumor Proportion Score (TPS) score.
Unresectable or metastatic disease.
Exclusion Criteria:
Prior systemic treatment for locally advanced or metastatic NSCLC including chemotherapy, immune checkpoint inhibitor therapy, or a therapy targeting KRAS G12C mutation (e.g., AMG 510).
Active brain metastases.
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There are 97 Locations for this study
Prescott Valley Arizona, 86314, United States
Tucson Arizona, 85715, United States
Springdale Arkansas, 72762, United States
Anaheim California, 92805, United States
San Francisco California, 94143, United States
Santa Rosa California, 95403, United States
Stockton California, 95219, United States
Whittier California, 90602, United States
Lone Tree Colorado, 80124, United States
Norwich Connecticut, 06360, United States
Bay Pines Florida, 33744, United States
Fort Myers Florida, 33901, United States
Fort Myers Florida, 33907, United States
Jacksonville Florida, 32204, United States
Jacksonville Florida, 32256, United States
Orlando Florida, 32804, United States
Tallahassee Florida, 32308, United States
Athens Georgia, 30607, United States
Chicago Illinois, 60637, United States
Niles Illinois, 60714, United States
Park Ridge Illinois, 60068, United States
Goshen Indiana, 46580, United States
Wichita Kansas, 67460, United States
Lexington Kentucky, 40503, United States
Covington Louisiana, 70433, United States
Baltimore Maryland, 21287, United States
Boston Massachusetts, 02215, United States
Burnsville Minnesota, 55337, United States
Jackson Mississippi, 39202, United States
Omaha Nebraska, 68130, United States
East Brunswick New Jersey, 08816, United States
Hackensack New Jersey, 07601, United States
Albany New York, 12206, United States
Bronx New York, 10467, United States
Durham North Carolina, 27710, United States
Cincinnati Ohio, 45242, United States
Cleveland Ohio, 44106, United States
Columbus Ohio, 43219, United States
Kettering Ohio, 45429, United States
Eugene Oregon, 97401, United States
Salem Oregon, 97301, United States
Sioux Falls South Dakota, 57105, United States
Germantown Tennessee, 38138, United States
Nashville Tennessee, 37203, United States
Arlington Texas, 76012, United States
Austin Texas, 78745, United States
Bedford Texas, 76022, United States
Dallas Texas, 75246, United States
Denison Texas, 75020, United States
The Woodlands Texas, 77380, United States
Tyler Texas, 75702, United States
Fairfax Virginia, 22031, United States
Richmond Virginia, 23230, United States
Woolloongabba Queensland, 4102, Australia
Edegem Antwerpen, 2650, Belgium
Gent Vlaams Brabant, 9000, Belgium
Vancouver British Columbia, V5Z 4, Canada
Toronto Ontario, M5G 2, Canada
Hořovice Central Bohemian, 268 3, Czechia
Esslingen Baden-Wuerttemberg, 73730, Germany
Kassel Hessen, 34125, Germany
Großhansdorf Schleswig-Holstein, 22927, Germany
Budapest , 1083, Hungary
Budapest , 1121, Hungary
Budapest , 1122, Hungary
Gyöngyös , 3200, Hungary
Torokbalint , 2045, Hungary
Meldola Forli-Cesena, 47014, Italy
Milan , 20141, Italy
Napoli , 80131, Italy
Parma , 43126, Italy
Roma , 00168, Italy
Incheon Gyeonggi-do, 22332, Korea, Republic of
Suwon-si Gyeonggi-do, 16247, Korea, Republic of
Busan , 48108, Korea, Republic of
Daegu , 41404, Korea, Republic of
Amsterdam Noord-Holland, 1066 , Netherlands
Rotterdam Zuid-Holland, 3015 , Netherlands
Harderwijk , 3844 , Netherlands
Utrecht , 3584 , Netherlands
Gdańsk Gdansk, 80-95, Poland
Lublin , 20-06, Poland
Skorzewo , 60-18, Poland
L'Hospitalet De Llobregat Barcelona, 08908, Spain
A Coruña La Coruña, 15006, Spain
Barcelona , 08025, Spain
Barcelona , 08028, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Málaga , 29011, Spain
Santiago De Compostela , 15706, Spain
Sevilla , 41013, Spain
Valencia , 46010, Spain
Valencia , 46026, Spain
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