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

Mirati Therapeutics

Status and phase: Enrolling; Phase 2

Conditions: Metastatic Cancer; Advanced Cancer; Malignant Neoplasm of Lung

Treatments: Drug: Adagrasib

Study type: Interventional

Funder types: Industry

Identifiers

NCT05853575

2023-503523-25 (Other Identifier)

CA239-0012

849-021

Details and patient eligibility

About

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.

Full description

CA239-0012 is a phase 2 study of adagrasib monotherapy in which patients are randomized between two dosing regimens. The study will evaluate the efficacy of two dosing regimens of adagrasib (600 mg BID without regard to food versus 400 mg BID with food) in patients with NSCLC with KRAS G12C mutation and who have received prior treatment with a platinum-based regimen and immune checkpoint inhibitor therapy.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion 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.

Key Exclusion Criteria:

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Adagrasib 600mg BID

Experimental group

Description:

Adagrasib 600mg BID without regard to food

Treatment:

Drug: Adagrasib

Adagrasib 400mg BID

Experimental group

Description:

Adagrasib 400mg BID with food

Treatment:

Drug: Adagrasib