Neoadjuvant KRAS G12C Directed Therapy With Adagrasib (MRTX849) With or Without Nivolumab

Phase 2 Withdrawn Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Bristol-Myers Squibb · collab Mirati Therapeutics Inc. · collab

RandomizedSequentialOpen-labelTreatment

Summary

This is an open label phase 2 clinical trial evaluating the clinical safety, feasibility and efficacy of neoadjuvant Adagrasib alone or in combination with nivolumab in patients with NSCLC with KRAS G12C mutation.

Timeline

Start: 2023-03-21
Primary completion: 2025-06-01
Completion: 2025-09-01

Publications

Luo J, Florez N, Donnelly A, Lou Y, Lu K, Ma PC, Spira AI, Ryan D, Husain H. Adagrasib Treatment After Sotorasib-Related Hepatotoxicity in Patients With KRASG12C-Mutated Non-Small Cell Lung Cancer: A Case Series and Literature Review. JCO Precis Oncol. 2024 Apr;8:e2300644. doi: 10.1200/PO.23.00644.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Adagrasib	Small molecule	400 mg	Oral
Comparator	Adagrasib	Small molecule	600 mg	Oral
Subject	Nivolumab	Monoclonal antibody	240 mg	Intravenous

Neoadjuvant KRAS G12C Directed Therapy With Adagrasib (MRTX849) With or Without Nivolumab

Summary

Timeline

Publications

Drugs

Indications