Phase 3 Study of MRTX849 (Adagrasib) vs Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation

NCT04685135 · tracked via the Priya Life Science UK tracker

Sponsor

Mirati Therapeutics Inc.

Phase

Phase 3

Started

2021-02-23

Last updated

2026-08-11

Condition(s) studied

Metastatic Non Small Cell Lung CancerAdvanced Non Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

MRTX849Docetaxel

MRTX849: 21 day cycles

Docetaxel: 21 day cycles

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Progression-Free Survival (PFS) as Per Blinded Independent Central Review — From randomization to the date of progression or death due to any cause, whichever occurs first (up to approximately 143 weeks)
Progression-free survival (PFS) is defined as the time from randomization to the date of progression or death due to any cause, whichever occurs first. 95% CI was obtained using Brookmeyer and Crowley method. Participants who are not observed to have progressed or died are censored at the date of last evaluable tumor assessment. Disease progression assessed as per RECISIST 1.1 was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

Trial sites (380)

Facility	City	Region
Local Institution - 012-898	Cerritos	California
Local Institution - 012-910	Duarte	California
Local Institution - 012-898 D	Glendale	California
Local Institution - 012-910-A	Huntington Beach	California
Local Institution - 012-910-C	Irvine	California
Local Institution - 012-910-B	Long Beach	California
Local Institution - 012-910-F	Long Beach	California
Local Institution - 012-910-D	Newport Beach	California
Local Institution - 012-898 C	Santa Ana	California
Local Institution - 012-858	Santa Rosa	California
Local Institution - 012-910-E	Torrance	California
Local Institution - 012-951-B	Denver	Colorado
Local Institution - 012-951	Lafayette	Colorado
Local Institution - 012-872	Lone Tree	Colorado
Local Institution - 012-951-A	Wheat Ridge	Colorado
Local Institution - 012-562-B	Fleming Island	Florida
Local Institution - 012-968	Fort Lauderdale	Florida
Local Institution - 012-562-D	Jacksonville	Florida
Local Institution - 012-853	Jacksonville	Florida
Local Institution - 012-562-E	Jacksonville	Florida
Local Institution - 012-562-A	Jacksonville	Florida
Local Institution - 012-562-C	Jacksonville	Florida
Local Institution - 012-562-F	Jacksonville	Florida
Local Institution - 012-562-G	Jacksonville	Florida
Local Institution - 012-562	Jacksonville	Florida
Local Institution - 012-825	Miami Beach	Florida
Local Institution - 012-973	Orlando	Florida
Local Institution - 012-877	Pensacola	Florida
Local Institution - 012-839	Plantation	Florida
Local Institution - 012-941	Athens	Georgia
Local Institution - 012-835 - A	Austell	Georgia
Local Institution - 012-835 - B	Carrollton	Georgia
Local Institution - 012-835 - C	Cartersville	Georgia
Local Institution - 012-835 - D	Douglasville	Georgia
Local Institution - 012-835	Marietta	Georgia
Local Institution - 012-917	Chicago	Illinois
Local Institution - 012-972	Chicago	Illinois
Local Institution - 012-972 C	Harvey	Illinois
Local Institution - 012-972 A	New Lenox	Illinois
Local Institution - 012-883	Niles	Illinois

+ 340 more sites — see the full list on the official registry below.

More Mirati Therapeutics Inc. trials in the UK

A Solid Tumor Study for Long Term Treatment of Cancer Patients Who Participated in Adagrasib Studies Recruiting

Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7 Recruiting

A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4) Recruiting

Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation (KRYSTAL-10) Active, not recruiting

Other trials for the same condition

Study of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects With Advanced or Metastatic NSCLC Without Actionable Genomic Alterations Active, not recruiting

Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in 1L Non-Small Cell Lung Cancer (TROPION-Lung07) Active, not recruiting

Autologous LN-145 in Patients With Metastatic Non-Small-Cell Lung Cancer Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04685135 on ClinicalTrials.gov ↗ ← All trials in the UK