A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)
Recruiting · NCT06875310 · Interventional (participants receive a specific treatment) · Lead sponsor: Mirati Therapeutics Inc.
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This is a trial to evaluate the efficacy, safety, and tolerability of adagrasib plus pembrolizumab plus platinum-doublet chemotherapy versus placebo plus pembrolizumab plus platinum-doublet chemotherapy in participants with previously untreated, locally advanced or metastatic NSCLC with KRAS G12C mutation
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 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Histologically or cytologically confirmed diagnosis of non-squamous NSCLC with evidence of KRAS G12C mutation via tumor sample and/or circulating tumor deoxyribonucleic acid (ctDNA).
- Locally advanced or metastatic disease.
- Measurable disease via computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1 criteria of at least 1 lesion.
- No prior systemic anti-cancer therapy given for advanced or metastatic disease.
- Not a candidate for definitive therapy (eg, chemoradiation or complete surgical resection).
- Participants with brain metastases are eligible for enrollment, including those with untreated brain metastases. Brain metastases must be asymptomatic and not in need of immediate local therapy. Any untreated brain metastases must be ≤ 20 mm in diameter.
- Any PD-L1 expression (0 to 100%) as determined by VENTANA PD-L1 (SP263) assay, Agilent PD-L1 IHC 22C3 pharmDx, or Agilent PD-L1 IHC 28-8 pharmDx.
Exclusion criteria
- Participants with an active autoimmune or inflammatory disease requiring systemic treatment within 2 years.
- Uncontrolled or significant cardiovascular conditions within 6 months prior to enrollment that are ongoing or with risk of recurrence.
- Inadequate bone marrow or liver function or electrocardiogram (ECG) abnormalities.
- Ongoing treatment with concomitant medication known to cause prolonged QTc interval and that cannot be switched to alternative treatment prior to study entry.
- Treatment targeting KRAS G12C mutation (eg, sotorasib, adagrasib) in any setting.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Where it is running
60 locations listed across 22 US states.
- Local Institution - 0347 - Birmingham, Alabama, United States
- Local Institution - 0686 - Springdale, Arkansas, United States
- Providence Medical Foundation - Fullerton, California, United States
- Local Institution - 0682 - Loma Linda, California, United States
- Helios Clinical Research - Long Beach, California, United States
- National Jewish Health Medical Center - Denver, Colorado, United States
- Medical Oncology Hematology Consultants, PA - Newark, Delaware, United States
- Local Institution - 0694 - Clearwater, Florida, United States
- Cancer Specialists of North Florida - Jacksonville, Florida, United States
- Local Institution - 0696 - Miami, Florida, United States
- Local Institution - 0680 - Ocala, Florida, United States
- Mid Florida Hematology and Oncology Center - Orange City, Florida, United States
- Cancer Care Centers of Brevard, Inc. - Palm Bay, Florida, United States
- Florida Clinical Trials Group. - Plantation, Florida, United States
- Local Institution - 0695 - St. Petersburg, Florida, United States
- Florida Clinical Trials Group. - Tamarac, Florida, United States
- Local Institution - 0647 - Tampa, Florida, United States
- Local Institution - 0699 - Tampa, Florida, United States
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital - Marietta, Georgia, United States
- Illinois Cancer Specialists - Arlington Heights, Illinois, United States
- Local Institution - 0676 - Chicago, Illinois, United States
- Springfield Clinic Main Campus - Springfield, Illinois, United States
- Northwest Cancer Centers, P.C. - Dyer, Indiana, United States
- Parkview Research Center at Parkview Regional Medical Center - Fort Wayne, Indiana, United States
- Local Institution - 0423 - Munster, Indiana, United States
- Mercy Medical Center - Cedar Rapids, Iowa, United States
- Saint Elizabeth Medical Center Edgewood - Edgewood, Kentucky, United States
- Local Institution - 0566 - Louisville, Kentucky, United States
- Owensboro Medical Health System - Owensboro, Kentucky, United States
- Mercy Health-Paducah Medical Oncology and Hematology - Paducah, Kentucky, United States
- Louisiana State University Health Sciences Shreveport - Shreveport, Louisiana, United States
- Local Institution - 0702 - Annapolis, Maryland, United States
- Maryland Oncology Hematology - Columbia - Columbia, Maryland, United States
- Local Institution - 0019 - Boston, Massachusetts, United States
- Local Institution - 0293 - Detroit, Michigan, United States
- Local Institution - 0685 - Fenton, Missouri, United States
- Local Institution - 0678 - Cooperstown, New York, United States
- Ellis Hospital - Schenectady, New York, United States
- White Plains Hospital - White Plains, New York, United States
- Local Institution - 0624 - Asheville, North Carolina, United States
- Local Institution - 0688 - Easton, Pennsylvania, United States
- Local Institution - 0376 - Hershey, Pennsylvania, United States
- WellSpan Oncology Research - York, Pennsylvania, United States
- Local Institution - 0681 - Greenville, South Carolina, United States
- Local Institution - 0658 - Greenville, South Carolina, United States
- SCRI Oncology Partners - Nashville, Tennessee, United States
- Local Institution - 0697 - Nashville, Tennessee, United States
- Texas Oncology Sammons Cancer Center - Dallas, Texas, United States
- Local Institution - 0692 - Galveston, Texas, United States
- Local Institution - 0652 - Laredo, Texas, United States
- Texas Oncology - San Antonio - San Antonio, Texas, United States
- Texas Oncology - Northeast Texas - Tyler, Texas, United States
- Baskent University Dr. Turgut Noyan Research and Training Center - Adana, Turkey (Türkiye)
- Local Institution - 0307 - Akashi, Japan
- Hacettepe Universite Hastaneleri - Ankara, Turkey (Türkiye)
- Ankara University Health Practice and Research Hospitals - Ankara, Turkey (Türkiye)
- Ankara Bilkent Şehir Hastanesi - Ankara, Turkey (Türkiye)
- Aomori Prefectural Central Hospital - Aomori, Japan
- Vivantes Klinikum Neukölln - Berlin, Germany
- Evangelische Lungenklinik Berlin - Berlin, Germany
Showing 60 of 351 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →