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

Running, not enrolling · Phase 3

Conditions studied: Metastatic Non Small Cell Lung Cancer, Advanced Non Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT04685135

Run by

Mirati Therapeutics Inc.

People needed

453

Starts

2021-02-23

Expected to finish

2026-07-02

Last updated by the study team

2025-01-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• City of Hope - Duarte (Main Campus) — Duarte, California, United States
• Local Institution - 012-898 D — Glendale, California, United States
• Local Institution - 012-910-A — Huntington Beach, California, United States
• Local Institution - 012-910-C — Irvine, California, United States
• City Of Hope — Long Beach, California, United States
• Local Institution - 012-910-F — Long Beach, California, United States
• Local Institution - 012-910-D — Newport Beach, California, United States
• Local Institution - 012-898 C — Santa Ana, California, United States
• Providence Medical Group - Santa Rosa — Santa Rosa, California, United States
• Local Institution - 012-910-E — Torrance, California, United States
• Local Institution - 012-951-B — Denver, Colorado, United States
• SCL Health - Saint Joseph Hospital Cancer Center — Lafayette, Colorado, United States
• Local Institution - 012-872 — Lone Tree, Colorado, United States
• Local Institution - 012-951-A — Wheat Ridge, Colorado, United States
• Local Institution - 012-562-B — Fleming Island, Florida, United States
• Holy Cross Health Fort Lauderdale - Holy Cross Hospital — Fort Lauderdale, Florida, United States
• 21st Century Oncology of Jacksonville - North Lee Street — Jacksonville, Florida, United States
• Local Institution - 012-562-D — Jacksonville, Florida, United States
• Local Institution - 012-562-E — Jacksonville, Florida, United States
• Local Institution - 012-562-A — Jacksonville, Florida, United States
• Local Institution - 012-562-C — Jacksonville, Florida, United States
• Local Institution - 012-562-F — Jacksonville, Florida, United States
• Local Institution - 012-562-G — Jacksonville, Florida, United States
• Local Institution - 012-562 — Jacksonville, Florida, United States
• Local Institution - 012-898 — Cerritos, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.