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.

View Full Description

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.

View Eligibility Criteria

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.

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

250

Study ID:

NCT04613596

Recruitment Status:

Recruiting

Sponsor:

Mirati Therapeutics Inc.

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There are 97 Locations for this study

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Prescott Valley Arizona, 86314, United States
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Tucson Arizona, 85715, United States
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Springdale Arkansas, 72762, United States
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Anaheim California, 92805, United States
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San Francisco California, 94143, United States
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Santa Rosa California, 95403, United States
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Stockton California, 95219, United States
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Whittier California, 90602, United States
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Lone Tree Colorado, 80124, United States
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Norwich Connecticut, 06360, United States
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Bay Pines Florida, 33744, United States
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Fort Myers Florida, 33901, United States
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Fort Myers Florida, 33907, United States
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Jacksonville Florida, 32204, United States
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Jacksonville Florida, 32256, United States
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Orlando Florida, 32804, United States
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Tallahassee Florida, 32308, United States
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Athens Georgia, 30607, United States
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Chicago Illinois, 60637, United States
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Niles Illinois, 60714, United States
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Park Ridge Illinois, 60068, United States
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Goshen Indiana, 46580, United States
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Wichita Kansas, 67460, United States
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Lexington Kentucky, 40503, United States
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Covington Louisiana, 70433, United States
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Baltimore Maryland, 21287, United States
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Boston Massachusetts, 02215, United States
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Burnsville Minnesota, 55337, United States
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Jackson Mississippi, 39202, United States
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Omaha Nebraska, 68130, United States
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East Brunswick New Jersey, 08816, United States
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Hackensack New Jersey, 07601, United States
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Albany New York, 12206, United States
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Bronx New York, 10467, United States
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Durham North Carolina, 27710, United States
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Cincinnati Ohio, 45242, United States
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Cleveland Ohio, 44106, United States
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Columbus Ohio, 43219, United States
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Kettering Ohio, 45429, United States
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Eugene Oregon, 97401, United States
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Salem Oregon, 97301, United States
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Sioux Falls South Dakota, 57105, United States
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Germantown Tennessee, 38138, United States
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Nashville Tennessee, 37203, United States
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Arlington Texas, 76012, United States
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Austin Texas, 78745, United States
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Bedford Texas, 76022, United States
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Dallas Texas, 75246, United States
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Denison Texas, 75020, United States
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The Woodlands Texas, 77380, United States
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Tyler Texas, 75702, United States
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Fairfax Virginia, 22031, United States
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Richmond Virginia, 23230, United States
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Woolloongabba Queensland, 4102, Australia
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Edegem Antwerpen, 2650, Belgium
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Gent Vlaams Brabant, 9000, Belgium
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Vancouver British Columbia, V5Z 4, Canada
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Toronto Ontario, M5G 2, Canada
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Hořovice Central Bohemian, 268 3, Czechia
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Esslingen Baden-Wuerttemberg, 73730, Germany
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Kassel Hessen, 34125, Germany
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Großhansdorf Schleswig-Holstein, 22927, Germany
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Budapest , 1083, Hungary
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Budapest , 1121, Hungary
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Budapest , 1122, Hungary
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Gyöngyös , 3200, Hungary
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Torokbalint , 2045, Hungary
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Meldola Forli-Cesena, 47014, Italy
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Milan , 20141, Italy
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Napoli , 80131, Italy
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Parma , 43126, Italy
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Roma , 00168, Italy
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Incheon Gyeonggi-do, 22332, Korea, Republic of
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Suwon-si Gyeonggi-do, 16247, Korea, Republic of
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Busan , 48108, Korea, Republic of
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Daegu , 41404, Korea, Republic of
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Amsterdam Noord-Holland, 1066 , Netherlands
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Rotterdam Zuid-Holland, 3015 , Netherlands
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Harderwijk , 3844 , Netherlands
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Utrecht , 3584 , Netherlands
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Gdańsk Gdansk, 80-95, Poland
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Lublin , 20-06, Poland
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Skorzewo , 60-18, Poland
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L'Hospitalet De Llobregat Barcelona, 08908, Spain
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A Coruña La Coruña, 15006, Spain
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Barcelona , 08025, Spain
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Barcelona , 08028, Spain
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Barcelona , 08035, Spain
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Barcelona , 08036, Spain
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Madrid , 28034, Spain
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Madrid , 28040, Spain
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Madrid , 28041, Spain
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Málaga , 29011, Spain
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Santiago De Compostela , 15706, Spain
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Sevilla , 41013, Spain
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Valencia , 46010, Spain
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Valencia , 46026, Spain

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

250

Study ID:

NCT04613596

Recruitment Status:

Recruiting

Sponsor:


Mirati Therapeutics Inc.

How clear is this clinincal trial information?

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