Clinical Trial

A Phase 3 Randomized Double-blind Study of Adjuvant Pembrolizumab With or Without V940 in Participants With Resectable Stage II to IIIB (N2) NSCLC not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy (INTerpath-009) (V940-009)

MOA: V940 is a lipid encapsulated mRNA based Individualized Neoantigen Therapy (INT) encoding neoantigens to induce specific T cells and associated anti-tumor responses (both CD8 and CD4)

Key Eligibility Criteria:

• Histologically/cytologically confirmed diagnosis of resectable Stage II, IIIA, or IIIB (N2) NSCLC
• No prior therapy (except pts enrolled after the neoadjuvant treatment and surgery)
• Pt who received up to 4 cycles of pembrolizumab and platinum-doublet chemotherapy, followed by R0 or R1 lobectomy or pneumonectomy, may enroll if all eligibility criteria are met
• No prior anti-PD(L)1 or with another stimulatory/coinhibitory TCR or cancer vaccine, including another INT
• Chemotherapy and pembrolizumab followed by surgery will be eligible
• Documentation of absence of tumor-activating EGFR mutations and ALK gene rearrangements