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

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedAdagrasib

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · KRAS · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 14, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Phase 2

Interventional

Where is it offered?98 U.S. locations

Locations may change over time.

Who runs it?Mirati Therapeutics Inc.

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: Mirati Therapeutics Inc.
Interventions being studied: Drug: Adagrasib

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Metastatic or stage IV→

Biomarkers

KRAS→

Treatment approach

Targeted therapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Key
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

Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Local Institution - 101Santa Rosa, California
Local Institution - 105Kansas City, Missouri
Local Institution - 100Durham, North Carolina
Local Institution - 106Dallas, Texas
Local Institution - 181Salvador, Estado de Bahia
Local Institution - 177Porto Alegre, Rio Grande do Sul
Local Institution - 182Itajaí, Santa Catarina
Local Institution - 178Belo Horizonte, São Paulo
Local Institution - 102São Paulo
Local Institution - 175São Paulo
Local Institution - 527Zagreb, City of Zagreb
Local Institution - 529Rijeka, Primorje-Gorski Kotar County

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 14, 2026. Always confirm current availability with the study team.

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