RECRUITING

Combination Therapies With Adagrasib in Patients With Advanced NSCLC With KRAS G12C Mutation

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Conditions

Advanced NSCLCMetastatic Lung CancerKRAS G12CNSCLCNon Small Cell Lung Cancer

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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

Study CA239-0010 is an open-label, Phase 2 clinical trial evaluating the clinical efficacy of adagrasib in combination with pembrolizumab and chemotherapy in the first-line setting for patients with advanced NSCLC with TPS ≥ 1%, TPS \<50% and KRAS G12C mutation

Official Title

A Phase 2 Trial of Combination Therapies With Adagrasib in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation

Quick Facts

Study Start:2022-11-30
Study Completion:2026-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05609578

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. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * All Cohorts: Any prior therapy targeting KRASG12C mutation in any setting
  2. * Cohorts A \& E: Prior systemic therapy for locally advanced or metastatic NSCLC, including chemotherapy, immune checkpoint inhibitor therapy or chemoimmunotherapy (note: prior systemic therapy or chemoradiation given in the adjuvant or neoadjuvant setting are allowed if last dose of prior systemic treatment was \>1 year prior to first dose of study treatment)
  3. * Cohort C: received maintenance therapy (e.g, pembrolizumab and/or pemetrexed following completion of 4-6 cycles of a platinum-based regimen administered in the first-line setting
  4. * Radiation to the lung \> 30 Gy within 6 months prior to first dose of study treatment
  5. * Active brain metastases

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 - Unk025
Anchorage, Alaska, 99508
United States
Local Institution - 017-591
Glendale, Arizona, 85304
United States
Local Institution - 017-821
Phoenix, Arizona, 85004
United States
Local Institution - Unk047
Anaheim, California, 92805
United States
Local Institution - 017-936C
Fountain Valley, California, 92708
United States
MemorialCare - Orange Coast Medical Center
Fountain Valley, California, 92708
United States
Providence Medical Foundation - Virginia K. Crosson Cancer Center - Fullerton
Fullerton, California, 92835
United States
Local Institution - Unk004
Loma Linda, California, 92354
United States
Local Institution - 017-961
Los Angeles, California, 90095
United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94158
United States
Local Institution - 017-872-I
Aurora, Colorado, 80012
United States
Local Institution - 017-872-G
Boulder, Colorado, 80303
United States
Local Institution - 017-872-D
Colorado Springs, Colorado, 80907
United States
Local Institution - 017-872-J
Colorado Springs, Colorado, 80920
United States
Local Institution - 017-872-B
Denver, Colorado, 80218
United States
Local Institution - 017-872-F
Denver, Colorado, 80220
United States
Local Institution - 017-872-A
Lakewood, Colorado, 80228
United States
Local Institution - 017-872-C
Littleton, Colorado, 80218
United States
USOR - Rocky Mountain Cancer Centers - Lone Tree
Lone Tree, Colorado, 80124
United States
Local Institution - 017-872-E
Pueblo, Colorado, 81003
United States
Local Institution - 017-872-H
Thornton, Colorado, 80260
United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224
United States
The Oncology Institute of Hope and Innovation - Lakeland
Lakeland, Florida, 33812
United States
Local Institution - Unk076
Miami, Florida, 33136
United States
Local Institution - Unk055
Orlando, Florida, 32803
United States
Local Institution - Unk062
Chicago, Illinois, 60612
United States
Local Institution - 017-972
Chicago, Illinois, 60637
United States
Local Institution - 017-820J
Fairway, Kansas, 66205
United States
Local Institution - 017-820A
Kansas City, Kansas, 66160
United States
Local Institution - 017-820B
Kansas City, Kansas, 66160
United States
Local Institution - 017-820C
Kansas City, Kansas, 66160
United States
Local Institution - 017-820H
Kansas City, Kansas, 66160
United States
Local Institution - 017-820I
Overland Park, Kansas, 66210
United States
University of Kansas Cancer Center - Westwood/Richard and Annette Bloch Cancer Care Pavilion
Westwood, Kansas, 66205
United States
Local Institution - 017-965
Lexington, Kentucky, 40503
United States
Local Institution - Unk009
Baltimore, Maryland, 21201
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Local Institution - Unk039
Burlington, Massachusetts, 01803
United States
Local Institution - Unk069
Detroit, Michigan, 48201
United States
Local Institution - Unk018
Lansing, Michigan, 488912
United States
Henry Ford Medical Center - Columbus
Novi, Michigan, 48377
United States
Local Institution - 017-838B
Minneapolis, Minnesota, 55404
United States
Local Institution - 017-838C
Minneapolis, Minnesota, 55404
United States
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
United States
Metro-Minnesota Community Oncology Research Consortium (MMCORC)
Saint Louis Park, Minnesota, 55416
United States
Local Institution - 017-838A
Saint Louis Park, Minnesota, 55426-5000
United States
Local Institution - 017-820F
Kansas City, Missouri, 64116
United States
Local Institution - 017-820E
Kansas City, Missouri, 64154
United States
Local Institution - 017-820D
Lee's Summit, Missouri, 64064
United States
Local Institution - 017-820G
North Kansas City, Missouri, 64116
United States
Local Institution - Unk008
Osage Beach, Missouri, 65065
United States
Local Institution - Unk058
Springfield, Missouri, 65807
United States
Local Institution - 017-080
Babylon, New York, 11702
United States
Local Institution - 017-945
Bronx, New York, 10467
United States
Local Institution - 017-083
Bronx, New York, 10469
United States
Local Institution - 017-088
Brooklyn, New York, 11210
United States
Hematology-Oncology Associates of Central New York - Brittonfield - East Syracuse
East Syracuse, New York, 13057
United States
Local Institution - 017-087
New Hyde Park, New York, 11042
United States
Local Institution - 017-085
New York, New York, 10028
United States
Local Institution - 017-082
Patchogue, New York, 11772
United States
Local Institution - 017-081
Port Jefferson Station, New York, 11776
United States
New York Cancer & Blood Specialists - Cancer Center - Research Headquarters
Port Jefferson Station, New York, 11776
United States
Local Institution - 017-086
Port Jefferson, New York, 11776
United States
Local Institution - 017-084
Riverhead, New York, 11901
United States
Cleveland Clinic Main Campus
Cleveland, Ohio, 44195
United States
Local Institution - 017-836
Kettering, Ohio, 45429
United States
Local Institution - 017-916
Memphis, Tennessee, 38104
United States
Texas Oncology - Dallas Fort Worth (DFW) - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
United States
Local Institution - Unk056
Dallas, Texas, 75390
United States
Local Institution - 017-848
Houston, Texas, 77030
United States
Local Institution - 017-999
Irving, Texas, 75063
United States
USOR - Texas Oncology Northeast Texas - Longview Cancer Center
Longview, Texas, 75601
United States
Local Institution - 017-878-B
Palestine, Texas, 75801
United States
Local Institution - 017-878-C
Paris, Texas, 75460
United States
Local Institution - 017-878-A
Tyler, Texas, 75702
United States
Local Institution - Unk010
Salt Lake City, Utah, 84106
United States
Local Institution - 017-814-A
Arlington, Virginia, 22205
United States
Local Institution - Unk066
Fairfax, Virginia, 22031
United States
Virginia Cancer Specialists - Fairfax Office
Fairfax, Virginia, 22031
United States
Local Institution - 017-814-B
Gainesville, Virginia, 20155
United States
Local Institution - 017-814-C
Reston, Virginia, 20190
United States
PeaceHealth St. Joseph Medical Center
Bellingham, Washington, 98225
United States
Local Institution - Unk036
Huntington, West Virginia, 25705
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 Date2022-11-30
Study Completion Date2026-12-01

Study Record Updates

Study Start Date2022-11-30
Study Completion Date2026-12-01

Terms related to this study

Keywords Provided by Researchers

  • KRAS G12C
  • NSCLC
  • Non Small Cell Lung Cancer

Additional Relevant MeSH Terms

  • Advanced NSCLC
  • Metastatic Lung Cancer