Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7
Recruiting · NCT04613596 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The Phase 2 portion of this 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. The Phase 3 portion of the study compares the efficacy of adagrasib in combination with pembrolizumab versus pembrolizumab in patients with unresectable, locally advanced or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS \>=50% and who are candidates for first line treatment.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2, Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Phase 2: Histologically confirmed diagnosis of unresectable or metastatic NSCLC with KRAS G12C mutation and any PD-L1 TPS
- Phase 3: Histologically confirmed diagnosis of unresectable or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS\>=50%
- Phase 3: Presence of measurable disease per RECIST1.1
- Phase 3: CNS Inclusion - Based on screening brain imaging, patients must have one of the following:
- No evidence of brain metastases
- Untreated brain metastases not needing immediate local therapy
- Previously treated brain metastases not needing immediate local therapy
Exclusion criteria
- Phase 2 and Phase 3: 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).
- Phase 2: Active brain metastases
- Phase 3: Patients with known central nervous system (CNS) lesions must not have any of the following:
- Any untreated brain lesions \> 2.0 cm in size
- Any brainstem lesions
- Ongoing use of systemic corticosteroids for control of symptoms of brain lesions at a total daily dose of \> 10 mg of prednisone (or equivalent) prior to randomization.
- Have poorly controlled (\> 1/week) generalized or complex partial seizures, or manifest neurologic progression due to brain lesions notwithstanding CNS-directed therapy
- Phase 3: Radiation to the lung \> 30 Gy within 6 months prior to the first dose of study treatment
Where it is running
60 locations listed across 36 US states.
- Local Institution - 007-556-A - Goodyear, Arizona, United States
- USOR - Arizona Oncology - Prescott Valley - Prescott Valley, Arizona, United States
- Local Institution - 007-568-A - Safford, Arizona, United States
- Local Institution - 007-568-B - Safford, Arizona, United States
- Local Institution - 007-568-C - Safford, Arizona, United States
- Local Institution - 007-568-D - Safford, Arizona, United States
- Local Institution - 007-568-E - Safford, Arizona, United States
- Arizona Clinical Research Center - Tucson, Arizona, United States
- Highlands Oncology Group - Springdale - Springdale, Arkansas, United States
- Providence - Saint Joseph Home Health - Anaheim - Anaheim, California, United States
- The Oncology Institute of Hope and Innovation - Corporate Office - Cerritos, California, United States
- Local Institution - 007-777 - Fountain Valley, California, United States
- Local Institution - 007-778 - Laguna Hills, California, United States
- Local Institution - 007-898-B - Long Beach, California, United States
- MemorialCare - Long Beach Medical Center - Long Beach, California, United States
- TRIO - Cancer & Blood Specialty Clinic - Los Alamitos - Los Alamitos, California, United States
- Local Institution - 007-579 - Los Angeles, California, United States
- Local Institution - Unk045 - Rancho Mirage, California, United States
- San Francisco Veterans Affairs Medical Center - San Francisco, California, United States
- UCSF Helen Diller Family Comprehensive Cancer Center - San Francisco, California, United States
- Local Institution - 007-898-C - Santa Ana, California, United States
- Providence Medical Group - Santa Rosa - Santa Rosa, California, United States
- Stockton Hematology Oncology Medical Group (SHOMG) - Stockton (Suite B) - Stockton, California, United States
- Local Institution - 007-898-A - Whittier, California, United States
- Local Institution - 007-872-H - Aurora, Colorado, United States
- Local Institution - 007-872-D - Boulder, Colorado, United States
- Local Institution - 007-872-L - Centennial, Colorado, United States
- Local Institution - 007-872-C - Colorado Springs, Colorado, United States
- Local Institution - 007-872-K - Colorado Springs, Colorado, United States
- Local Institution - 007-872-E - Denver, Colorado, United States
- Local Institution - 007-872-I - Denver, Colorado, United States
- Local Institution - 007-872-A - Lakewood, Colorado, United States
- Local Institution - 007-872-J - Littleton, Colorado, United States
- USOR - Rocky Mountain Cancer Centers - Lone Tree - Lone Tree, Colorado, United States
- Local Institution - 007-872-G - Longmont, Colorado, United States
- Local Institution - 007-872-B - Pueblo, Colorado, United States
- Local Institution - 007-872-F - Thornton, Colorado, United States
- Eastern Connecticut Hematology and Oncology Associates - Norwich, Connecticut, United States
- Local Institution - 007-5476 - Washington D.C., District of Columbia, United States
- GenesisCare USA - Aventura, Florida, United States
- Bay Pines Veterans Affairs Healthcare System - Bay Pines, Florida, United States
- Local Institution - 007-922-A - Bonita Springs, Florida, United States
- Local Institution - 007-922-D - Bradenton, Florida, United States
- Local Institution - 007-922-E - Cape Coral, Florida, United States
- Local Institution - 007-896-A - Celebration, Florida, United States
- Local Institution - 007-926-B - Daytona Beach, Florida, United States
- Local Institution - 007-562-B - Fleming Island, Florida, United States
- SCRI - Florida Cancer Specialists - South Region Research Office - Fort Myers, Florida, United States
- Local Institution - 007-922-B - Fort Myers, Florida, United States
- Local Institution - 007-922-C - Fort Myers, Florida, United States
- 21st Century Oncology of Jacksonville - North Lee Street - Jacksonville, Florida, United States
- Local Institution - 007-562-D - Jacksonville, Florida, United States
- Local Institution - 007-562-E - Jacksonville, Florida, United States
- Local Institution - 007-562-G - Jacksonville, Florida, United States
- Local Institution - 007-829 - Jacksonville, Florida, United States
- Cancer Specialists of North Florida - Southpoint - Jacksonville, Florida, United States
- Local Institution - 007-562-C - Jacksonville, Florida, United States
- Local Institution - 007-562-F - Jacksonville Beach, Florida, United States
- Miami Veterans Affairs Healthcare System - Miami, Florida, United States
- Local Institution - 007-922-F - Naples, Florida, United States
Showing 60 of 770 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →