RECRUITING

Trial of Two Adagrasib Dosing Regimens in NSCLC With KRAS G12C Mutation (KRYSTAL 21)

Conditions

Advanced Cancer Metastatic Cancer Malignant Neoplasm of Lung KRAS G12C Non-small cell lung cancer NSCLC

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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

This study will evaluate the efficacy of two dosing regimens of adagrasib (600 mg BID versus 400 mg BID) in patients with NSCLC with KRAS G12C mutation.

Official Title

A Randomized Study of Two Dosing Regimens of Adagrasib in Patients With Previously Treated Non-Small Cell Lung Cancer With KRAS G12C Mutation

Quick Facts

Study Start:2024-02-16

Study Completion:2025-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05853575

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 Criteria	Exclusion Criteria
* Are at least 18 years old (or old enough to legally make their own treatment decisions, according to local laws). * Have advanced NSCLC or metastatic NSCLC (NSCLC that started in the lungs and then spread to other parts of the body) with the KRAS G12C mutation. * Have had previous treatment with 1) chemotherapy that included a drug called cisplatin or a drug called carboplatin and 2) a type of drug called an immune checkpoint inhibitor. * Have recovered from their prior treatment and blood tests are within a safe range.	* Have had previous treatment with a drug that targets KRAS G12C. * Have cancer that can potentially be removed with surgery. * Patients with brain lesions are not eligible if 1) any untreated brain lesions are \> 2.0 cm in size 2) any brainstem lesions are present 3) ongoing steroid dosing \>10 mg daily prednisone (or equivalent) and 4) poorly controlled (\> 1/week) generalized or complex partial seizures or neurologic progression/instability due to brain lesions. * Have certain medical conditions or need to take certain medications that, in the opinion of a trial doctor, could make it unsafe for them to participate or difficult to complete the trial assessments, or are pregnant.

Inclusion Criteria

Exclusion Criteria

* Are at least 18 years old (or old enough to legally make their own treatment decisions, according to local laws).
* Have advanced NSCLC or metastatic NSCLC (NSCLC that started in the lungs and then spread to other parts of the body) with the KRAS G12C mutation.
* Have had previous treatment with 1) chemotherapy that included a drug called cisplatin or a drug called carboplatin and 2) a type of drug called an immune checkpoint inhibitor.
* Have recovered from their prior treatment and blood tests are within a safe range.

* Have had previous treatment with a drug that targets KRAS G12C.
* Have cancer that can potentially be removed with surgery.
* Patients with brain lesions are not eligible if 1) any untreated brain lesions are \> 2.0 cm in size 2) any brainstem lesions are present 3) ongoing steroid dosing \>10 mg daily prednisone (or equivalent) and 4) poorly controlled (\> 1/week) generalized or complex partial seizures or neurologic progression/instability due to brain lesions.
* Have certain medical conditions or need to take certain medications that, in the opinion of a trial doctor, could make it unsafe for them to participate or difficult to complete the trial assessments, or are pregnant.

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)

Providence Medical Foundation

Santa Rosa, California, 95403

United States

Local Institution - 106

Chicago, Illinois, 60612

United States

Local Institution - 103

Minneapolis, Minnesota, 55417

United States

Local Institution - 105

Kansas City, Missouri, 64128

United States

Veterans Affairs Medical Center (VAMC) - Durham

Durham, North Carolina, 27705

United States

VA North Texas Healthcare System/Dallas VA Medical Center

Dallas, Texas, 75216-7167

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 Date2024-02-16

Study Completion Date2025-09-30

Study Record Updates

Study Start Date2024-02-16

Study Completion Date2025-09-30

Terms related to this study

Keywords Provided by Researchers

KRAS G12C
Non-small cell lung cancer
Metastatic cancer
NSCLC

Additional Relevant MeSH Terms

Advanced Cancer
Metastatic Cancer
Malignant Neoplasm of Lung