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

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.

Conditions

Advanced Cancer, Metastatic Cancer, Malignant Neoplasm of Lung

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Advanced Cancer
Intervention / Treatment

-

Contacts and Locations

Santa Rosa

Providence Medical Foundation, Santa Rosa, California, United States, 95403

Chicago

Local Institution - 106, Chicago, Illinois, United States, 60612

Minneapolis

Local Institution - 103, Minneapolis, Minnesota, United States, 55417

Kansas City

Local Institution - 105, Kansas City, Missouri, United States, 64128

Durham

Veterans Affairs Medical Center (VAMC) - Durham, Durham, North Carolina, United States, 27705

Dallas

VA North Texas Healthcare System/Dallas VA Medical Center, Dallas, Texas, United States, 75216-7167

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Mirati Therapeutics Inc.,

Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

2025-09-30