RECRUITING

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

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Conditions

Advanced Non-Small Cell Lung CancerMetastatic Non-Small Cell Lung CancerKRAS G12CNon-small cell lung cancerNSCLCAdagrasibKrazatiTPS

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation

Quick Facts

Study Start:2020-12-02
Study Completion:2029-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04613596

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Phase 2: Histologically confirmed diagnosis of unresectable or metastatic NSCLC with KRAS G12C mutation and any PD-L1 TPS
  2. * Phase 3: Histologically confirmed diagnosis of unresectable or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS \>=50%
  3. * Phase 3: Presence of evaluable or measurable disease per RECIST
  4. * Phase 3: CNS Inclusion - Based on screening brain imaging, patients must have one of the following:
  5. 1. No evidence of brain metastases
  6. 2. Untreated brain metastases not needing immediate local therapy
  7. 3. Previously treated brain metastases not needing immediate local therapy
  1. * 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).
  2. * Phase 2: Active brain metastases
  3. * Phase 3: Patients with known central nervous system (CNS) lesions must not have any of the following:
  4. 1. Any untreated brain lesions \> 1.0 cm in size
  5. 2. Any brainstem lesions
  6. 3. 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.
  7. 4. Have poorly controlled (\> 1/week) generalized or complex partial seizures, or manifest neurologic progression due to brain lesions notwithstanding CNS-directed therapy
  8. * Phase 3: Radiation to the lung \> 30 Gy within 6 months prior to the first dose of study treatment

Contacts and Locations

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
855-907-3286
Clinical.Trials@bms.com
First line of the email MUST contain the NCT# and Site #.
CONTACT

Principal Investigator

Bristol-Myers Squibb
STUDY_DIRECTOR
Bristol-Myers Squibb

Study Locations (Sites)

Local Institution - 007-556-A
Goodyear, Arizona, 85395
United States
USOR - Arizona Oncology - Prescott Valley
Prescott Valley, Arizona, 86301
United States
Local Institution - 007-568-A
Safford, Arizona, 85546
United States
Local Institution - 007-568-B
Safford, Arizona, 85546
United States
Local Institution - 007-568-C
Safford, Arizona, 85546
United States
Local Institution - 007-568-D
Safford, Arizona, 85546
United States
Local Institution - 007-568-E
Safford, Arizona, 85546
United States
Arizona Clinical Research Center
Tucson, Arizona, 85715
United States
Highlands Oncology Group - Springdale
Springdale, Arkansas, 72762
United States
Providence - Saint Joseph Home Health - Anaheim
Anaheim, California, 92805
United States
The Oncology Institute of Hope and Innovation - Corporate Office
Cerritos, California, 90703
United States
Local Institution - 007-777
Fountain Valley, California, 92708
United States
Local Institution - 007-778
Laguna Hills, California, 92653
United States
Local Institution - 007-898-B
Long Beach, California, 90805
United States
MemorialCare - Long Beach Medical Center
Long Beach, California, 90806
United States
TRIO - Cancer and Blood Specialty Clinic
Los Alamitos, California, 90720
United States
Local Institution - 007-579
Los Angeles, California, 90048
United States
Local Institution - Unk045
Rancho Mirage, California, 92270
United States
San Francisco Veterans Affairs Medical Center
San Francisco, California, 94121
United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94158
United States
Local Institution - 007-898-C
Santa Ana, California, 92705
United States
Providence Medical Group - Santa Rosa
Santa Rosa, California, 95403
United States
Stockton Hematology Oncology Medical Group (SHOMG) - Stockton (Suite B)
Stockton, California, 95219
United States
Local Institution - 007-898-A
Whittier, California, 90602
United States
Local Institution - 007-872-H
Aurora, Colorado, 80012
United States
Local Institution - 007-872-D
Boulder, Colorado, 80303
United States
Local Institution - 007-872-L
Centennial, Colorado, 80112
United States
Local Institution - 007-872-C
Colorado Springs, Colorado, 80907
United States
Local Institution - 007-872-K
Colorado Springs, Colorado, 80920
United States
Local Institution - 007-872-E
Denver, Colorado, 80218
United States
Local Institution - 007-872-I
Denver, Colorado, 80220
United States
Local Institution - 007-872-A
Lakewood, Colorado, 80228
United States
Local Institution - 007-872-J
Littleton, Colorado, 80218
United States
USOR - Rocky Mountain Cancer Centers - Lone Tree
Lone Tree, Colorado, 80124
United States
Local Institution - 007-872-G
Longmont, Colorado, 80504
United States
Local Institution - 007-872-B
Pueblo, Colorado, 81003
United States
Local Institution - 007-872-F
Thornton, Colorado, 80260
United States
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, 06360
United States
Local Institution - 007-5476
Washington, District of Columbia, 20010
United States
GenesisCare USA
Aventura, Florida, 33180
United States
Bay Pines Veterans Affairs Healthcare System
Bay Pines, Florida, 33744
United States
Local Institution - 007-922-A
Bonita Springs, Florida, 34135
United States
Local Institution - 007-922-D
Bradenton, Florida, 34211
United States
Local Institution - 007-922-E
Cape Coral, Florida, 33909
United States
Local Institution - 007-896-A
Celebration, Florida, 34747
United States
Local Institution - 007-926-B
Daytona Beach, Florida, 32117
United States
Local Institution - 007-562-B
Fleming Island, Florida, 32003
United States
SCRI - Florida Cancer Specialists - South Region Research Office
Fort Myers, Florida, 33901
United States
Local Institution - 007-922-B
Fort Myers, Florida, 33905
United States
Local Institution - 007-922-C
Fort Myers, Florida, 33908
United States
Local Institution - 007-562-F
Jacksonville Beach, Florida, 32250
United States
21st Century Oncology of Jacksonville - North Lee Street
Jacksonville, Florida, 32204
United States
Local Institution - 007-562-D
Jacksonville, Florida, 32204
United States
Local Institution - 007-562-E
Jacksonville, Florida, 32207
United States
Local Institution - 007-562-G
Jacksonville, Florida, 32218
United States
Local Institution - 007-829
Jacksonville, Florida, 32224
United States
Cancer Specialists of North Florida - Southpoint
Jacksonville, Florida, 32256
United States
Local Institution - 007-562-C
Jacksonville, Florida, 32258
United States
Miami Veterans Affairs Healthcare System
Miami, Florida, 33125-1624
United States
Local Institution - 007-922-F
Naples, Florida, 34102
United States
Local Institution - 007-922-G
Naples, Florida, 34102
United States
AdventHealth Orlando
Orlando, Florida, 32803
United States
USOR - Woodlands Medical Specialists
Pensacola, Florida, 32503
United States
Local Institution - 007-922-H
Port Charlotte, Florida, 33980
United States
Local Institution - 007-562-A
Saint Augustine, Florida, 32086
United States
Local Institution - 007-922-I
Sarasota, Florida, 34232
United States
Local Institution - 007-922-J
Sarasota, Florida, 34236
United States
Local Institution - 007-926-D
Stuart, Florida, 34994
United States
Local Institution - 007-924-A
Tallahassee, Florida, 32308
United States
SCRI - Florida Cancer Specialists - Tallahassee Cancer Center
Tallahassee, Florida, 32308
United States
James A. Haley Veterans Hospital
Tampa, Florida, 33612
United States
Local Institution - Unk065
Tampa, Florida, 33612
United States
Local Institution - 007-922-L
Venice, Florida, 34285
United States
Local Institution - 007-922-K
Venice, Florida, 34292
United States
Local Institution - 007-926-C
Vero Beach, Florida, 32960
United States
Local Institution - 007-926-A
Wellington, Florida, 33414
United States
SCRI - Florida Cancer Specialists - West Palm Beach
West Palm Beach, Florida, 33401
United States
Local Institution - Unk072
Weston, Florida, 33331
United States
University Cancer & Blood Center (UCBC) - Athens
Athens, Georgia, 30607
United States
Local Institution - Unk052
Atlanta, Georgia, 30318
United States
Local Institution - 007-786-C
Carrollton, Georgia, 30117
United States
Local Institution - 007-786-A
Cartersville, Georgia, 30121
United States
Local Institution - 007-786-D
Douglasville, Georgia, 30134
United States
Local Institution - 007-786-B
Hiram, Georgia, 30141
United States
Northwest Georgia Oncology Centers Wellstar - Marietta
Marietta, Georgia, 30060
United States
Local Institution - 007-897
Honolulu, Hawaii, 96813
United States
Local Institution - Unk005
Honolulu, Hawaii, 96813
United States
Local Institution - 007-883-A
Arlington Heights, Illinois, 60005
United States
Local Institution - 007-955
Chicago, Illinois, 60612
United States
University of Chicago
Chicago, Illinois, 60637
United States
Local Institution - 007-064
Maywood, Illinois, 60153
United States
USOR - Illinois Cancer Specialists - Niles
Niles, Illinois, 60714
United States
Advocate Medical Group Oncology
Park Ridge, Illinois, 60068
United States
Local Institution - Unk061
Peoria, Illinois, 61603-3200
United States
Goshen Center for Cancer Care
Goshen, Indiana, 46526
United States
Local Institution - 007-942-B
Chanute, Kansas, 66720
United States
Local Institution - 007-942-D
El Dorado, Kansas, 67042
United States
Local Institution - 007-942-E
Independence, Kansas, 67301
United States
Local Institution - 007-942-F
Kingman, Kansas, 67068
United States
Local Institution - 007-942-G
Liberal, Kansas, 67901
United States
Local Institution - 007-942-H
McPherson, Kansas, 67460
United States
Local Institution - 007-5484
Merriam, Kansas, 66204
United States
Local Institution - 007-942-I
Newton, Kansas, 67114
United States
Local Institution - 007-942-J
Parsons, Kansas, 67357
United States
Local Institution - 007-942-K
Pratt, Kansas, 67124
United States
Local Institution - 007-942-L
Salina, Kansas, 67401
United States
Local Institution - 007-942-M
Wellington, Kansas, 67152
United States
Local Institution - Unk032
Westwood, Kansas, 66205
United States
Local Institution - 007-942-A
Wichita, Kansas, 67208
United States
Cancer Center of Kansas - Wichita - Heritage Plaza
Wichita, Kansas, 67214
United States
Local Institution - 007-942-N
Winfield, Kansas, 67156
United States
Lexington Medical Cancer Center Hematology/Oncology
Lexington, Kentucky, 40503
United States
University of Louisville
Louisville, Kentucky, 40202
United States
Local Institution - 007-388-A
Louisville, Kentucky, 40245
United States
Local Institution - Unk011
Baton Rouge, Louisiana, 70809
United States
Local Institution - 007-994-A
Covington, Louisiana, 70433
United States
Pontchartrain Cancer Center - Covington Office
Covington, Louisiana, 70433
United States
The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Dana-Farber Cancer Institute at St. Elizabeths Medical Center
Brighton, Massachusetts, 02135
United States
Brigham and Womens/Mass General Health Care Center at Foxborough
Foxboro, Massachusetts, 02035
United States
Dana-Farber Cancer Institute - Merrimack Valley
Methuen, Massachusetts, 01844
United States
Dana-Farber Brigham and Womens Cancer Center at Milford Regional
Milford, Massachusetts, 01757
United States
Dana-Farber Brigham Cancer Center at South Shore Health
South Weymouth, Massachusetts, 02190
United States
USOR - Minnesota Oncology - Burnsville
Burnsville, Minnesota, 55337
United States
Local Institution - 007-589A
Edina, Minnesota, 55435
United States
Local Institution - Unk006
Minneapolis, Minnesota, 55404
United States
Local Institution - 007-822
Minneapolis, Minnesota, 55455
United States
Local Institution - 007-830
Rochester, Minnesota, 55905
United States
Jackson Oncology Associates - The Hederman Cancer Center
Jackson, Mississippi, 39202
United States
Local Institution - 007-590D
Grand Island, Nebraska, 68803
United States
Local Institution - 007-590A
Omaha, Nebraska, 68114-4108
United States
Local Institution - 007-590B
Omaha, Nebraska, 68124
United States
Nebraska Cancer Specialists - Midwest Cancer Center - Legacy
Omaha, Nebraska, 68130
United States
Local Institution - 007-590C
Papillion, Nebraska, 68046
United States
OptumCare Nevada
Las Vegas, Nevada, 89106
United States
Local Institution - 007-938A
Las Vegas, Nevada, 89148
United States
Local Institution - 007-938B
Las Vegas, Nevada, 89148
United States
Local Institution - 007-993
Belleville, New Jersey, 07109
United States
Astera Cancer Care - East Brunswick
East Brunswick, New Jersey, 08816
United States
John Theurer Cancer Center
Hackensack, New Jersey, 07601
United States
Local Institution - 007-975-A
Somerset, New Jersey, 08873-5002
United States
Local Institution - 007-975-B
Somerset, New Jersey, 08873-5002
United States
Local Institution - 007-975-C
Somerset, New Jersey, 08873-5002
United States
Local Institution - 007-975-D
Somerset, New Jersey, 08873-5002
United States
Holy Name Medical Center
Teaneck, New Jersey, 07666
United States
New York Oncology Hematology - Albany Medical Center
Albany, New York, 12208
United States
Montefiore Medical Center
Bronx, New York, 10467
United States
Local Institution - Unk077
Rhinebeck, New York, 12572
United States
Duke University Medical Center
Durham, North Carolina, 27710
United States
Local Institution - 007-893-B
Cincinnati, Ohio, 45211
United States
USOR - Oncology Hematology Care - Blue Ash
Cincinnati, Ohio, 45242
United States
Local Institution - 007-893-C
Cincinnati, Ohio, 45245
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States
Mark H. Zangmeister Cancer Center
Columbus, Ohio, 43219
United States
Local Institution - 007-893-A
Fairfield, Ohio, 45014
United States
Kettering Health Cancer Center - Main Campus
Kettering, Ohio, 45429
United States
USOR - Willamette Valley Cancer Institute and Research Center - Eugene
Eugene, Oregon, 97401
United States
Local Institution - 007-885B
Portland, Oregon, 97213
United States
Local Institution - 007-885A
Portland, Oregon, 97227
United States
Oregon Oncology Specialists
Salem, Oregon, 97301
United States
Local Institution - 007-885C
Tigard, Oregon, 97223
United States
Local Institution - Unk041
Allentown, Pennsylvania, 18103-6218
United States
Local Institution - 007-5477
Pittsburgh, Pennsylvania, 15240
United States
Local Institution - 007-960
Providence, Rhode Island, 02903
United States
Local Institution - Unk038
Charleston, South Carolina, 29414
United States
Local Institution - 007-5475
Spartanburg, South Carolina, 29303
United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
United States
Local Institution - 007-928-L
Dickson, Tennessee, 37055
United States
Local Institution - 007-928-J
Franklin, Tennessee, 37067
United States
Local Institution - 007-928-G
Gallatin, Tennessee, 37066
United States
West Cancer Center & Research Institute - East Campus
Germantown, Tennessee, 38138
United States
Local Institution - 007-928-A
Hendersonville, Tennessee, 37075
United States
Local Institution - 007-928-D
Hermitage, Tennessee, 37076
United States
Local Institution - 007-928-H
Lebanon, Tennessee, 37090
United States
Local Institution - 007-928-F
Murfreesboro, Tennessee, 37129
United States
Local Institution - 007-928-B
Nashville, Tennessee, 37203
United States
Tennessee Oncology - Nashville - Centennial Clinic - Medical Oncology
Nashville, Tennessee, 37203
United States
Local Institution - 007-928-K
Nashville, Tennessee, 37205
United States
Local Institution - 007-928-E
Nashville, Tennessee, 37207
United States
Local Institution - 007-928-C
Nashville, Tennessee, 37211
United States
Local Institution - 007-928-M
Shelbyville, Tennessee, 37160
United States
Local Institution - 007-928-I
Smyrna, Tennessee, 37167
United States
Local Institution - 007-554B
Abilene, Texas, 79606
United States
Local Institution - 007-554G
Amarillo, Texas, 79124
United States
Local Institution - 007-879-A
Arlington, Texas, 76012
United States
Local Institution - 007-879-B
Arlington, Texas, 76014
United States
Local Institution - 007-892-B
Austin, Texas, 78705
United States
Local Institution - 007-892-A
Austin, Texas, 78731
United States
USOR - Texas Oncology - Dallas Fort Worth (DFW) - South Austin
Austin, Texas, 78745
United States
Local Institution - 007-879-C
Bedford, Texas, 76022
United States
Local Institution - Unk059
Dallas, Texas, 75204
United States
Local Institution - 007-592
Dallas, Texas, 75216
United States
Texas Oncology - Dallas Fort Worth (DFW) - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
United States
USOR - Texas Oncology Northeast Texas - Denison
Denison, Texas, 75020
United States
Local Institution - 007-554E
El Paso, Texas, 79902
United States
Local Institution - 007-554C
El Paso, Texas, 79915
United States
Local Institution - 007-554F
El Paso, Texas, 79938
United States
USOR - Texas Oncology - Fredericksburg
Fredericksburg, Texas, 78624
United States
Local Institution - 007-848
Houston, Texas, 77030
United States
Local Institution - 007-999
Irving, Texas, 75063
United States
Local Institution - 007-890-B
Longview, Texas, 75601
United States
Local Institution - 007-554A
Midland, Texas, 79701
United States
USOR - Texas Oncology - Dallas Fort Worth (DFW) - Odessa West Texas Cancer Center
Odessa, Texas, 79761
United States
USOR - Texas Oncology - The Woodlands
The Woodlands, Texas, 77380
United States
Local Institution - 007-890-A
Tyler, Texas, 75702
United States
Local Institution - 007-554D
Wichita Falls, Texas, 76310
United States
Local Institution - 007-912
Salt Lake City, Utah, 84112
United States
Local Institution - 007-814-A
Alexandria, Virginia, 22304
United States
Local Institution - 007-814-D
Arlington, Virginia, 22201
United States
USOR - Virginia Cancer Specialists - Fairfax Office
Fairfax, Virginia, 22031
United States
Local Institution - 007-814-B
Gainesville, Virginia, 20155
United States
Local Institution - 007-814-C
Leesburg, Virginia, 20176
United States
Virginia Cancer Institute - West End
Richmond, Virginia, 23229
United States
USOR - Northwest Cancer Specialists, P.C. dba Compass Oncology - Vancouver Cancer Center
Vancouver, Washington, 98684
United States
Local Institution - Unk064
Huntington, West Virginia, 25705
United States
Local Institution - Unk057
Madison, Wisconsin, 53715
United States
Local Institution - Unk068
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: Mirati Therapeutics Inc.

  • Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-12-02
Study Completion Date2029-10-31

Study Record Updates

Study Start Date2020-12-02
Study Completion Date2029-10-31

Terms related to this study

Keywords Provided by Researchers

  • KRAS G12C
  • Non-small cell lung cancer
  • NSCLC
  • Metastatic Non-Small Cell Lung Cancer
  • Adagrasib
  • Krazati
  • TPS

Additional Relevant MeSH Terms

  • Advanced Non-Small Cell Lung Cancer
  • Metastatic Non-Small Cell Lung Cancer