Publication: IND242A substudy

Spicer J, Blais N, Owen S, Robinson AG, Chu Q, Labbe C, Shieh B, Brown-Walker P, Sederias J, Jensen K, Farago AF, Tsao MS, Cottrell TR, Kidane B, Laurie S, Juergens R, Bradbury PA, Tu W, Gaudreau PO. A Phase II Study of Neoadjuvant Opnurasib KRAS G12C Inhibitor in Patients With Surgically Resectable Non-Small Cell Lung Cancer (CCTG IND.242A): A Substudy of the IND.242 Platform Master Protocol. Clin Lung Cancer 26: 146-151. 2025.

 

The CCTG IND.242 neoadjuvant platform aims to provide novel data for molecularly defined NSCLC patient populations to inform future late-phase studies. In addition, the platform will provide the opportunity to explore effects of novel therapies on the tumor immune microenvironment through advanced correlative analyses on collected pre- and post-treatment biospecimens. Patients with KRAS mutations may be less responsive to platinum-based chemotherapy and may have worse clinical outcomes, highlighting that systemic targeted therapies are an unmet clinical need for these patients. Thus, the initial IND.242A substudy is designed to provide novel data regarding: neoadjuvant opnurasib MPR rate; secondary clinical outcomes including safety, pCR, ORR by RECIST 1.1, 2-year EFS rate, and surgical outcomes; exploratory endpoints including PROs and potential biomarkers of response and resistance.