NCT04685135

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

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 453 (actual)
• Sponsor: Mirati Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Non Small Cell Lung Cancer
• Advanced Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	MRTX849	21 day cycles
DRUG	Docetaxel	21 day cycles

Timeline

• Start date: 2021-02-23
• Primary completion: 2023-12-30
• Completion: 2026-07-02
• First posted: 2020-12-28
• Last updated: 2025-01-22
• Results posted: 2025-01-22

Locations

343 sites across 23 countries: United States, Australia, Austria, Belgium, Czechia, France, Germany, Greece, Hong Kong, Hungary, Ireland, Italy, Netherlands, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Korea, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study