Suspended

KRYSTAL-12A Randomized Phase 3 Study of MRTX849 Versus Docetaxel in Patients With Previously Treated Non-Small Cell Lung Cancer With KRAS G12C Mutation

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What is being tested

MRTX849

+ Docetaxel

Drug
Who is being recruted

Bronchial Neoplasms+11

+ Carcinoma, Bronchogenic

+ Carcinoma, Non-Small-Cell Lung

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: February 2021
See protocol details

Summary

Principal SponsorMirati Therapeutics Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 23, 2021

Actual date on which the first participant was enrolled.

This Phase 3 study will evaluate the efficacy of the investigational agent MRTX849 (adagrasib) versus docetaxel in patients who have been previously treated for metastatic NSCLC with a KRAS G12C mutation.

Official TitleA Randomized Phase 3 Study of MRTX849 Versus Docetaxel in Patients With Previously Treated Non-Small Cell Lung Cancer With KRAS G12C Mutation
NCT04685135
Principal SponsorMirati Therapeutics Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

453 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial NeoplasmsCarcinoma, BronchogenicCarcinoma, Non-Small-Cell LungLung DiseasesLung NeoplasmsNeoplasm MetastasisNeoplasmsNeoplasms by SiteNeoplastic ProcessesPathologic ProcessesRespiratory Tract DiseasesRespiratory Tract NeoplasmsPathological Conditions, Signs and SymptomsThoracic Neoplasms

Criteria

Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of NSCLC with KRAS G12C mutation. * Candidacy to receive treatment with docetaxel. Crossover Inclusion Criteria: * Evidence of RECIST 1.1 defined disease progression on docetaxel per BICR * ECOG performance status 0-2 Exclusion Criteria: * Prior treatment with an agent targeting KRAS G12C (e.g., AMG 510, Sotorasib). * Active brain metastases. Crossover Exclusion Criteria: * Receipt of any other systemic anti-cancer therapy after last administration of docetaxel on the study.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Group II

Active Comparator

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 343 locations

Suspended

University Cancer & Blood Center (UCBC) - Athens

Athens, United StatesOpen University Cancer & Blood Center (UCBC) - Athens in Google Maps
Suspended

Local Institution - 012-835 - A

Austell, United States
Suspended

Local Institution - 012-569 - B

Lafayette, United States
Suspended

Local Institution - 012-569 - C

Lafayette, United States
Suspended343 Study Centers