A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009)

Launched by MERCK SHARP & DOHME LLC · Sep 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether a combination of two treatments, pembrolizumab and V940, can help people with non-small cell lung cancer (NSCLC) stay cancer-free for a longer time after surgery. Participants in the trial will either receive the combination of these treatments or a placebo (a treatment that looks like the real one but doesn’t contain active ingredients) along with pembrolizumab. The goal is to see if adding V940 can improve outcomes for patients whose tumors did not completely respond to treatment before their surgery.

To be eligible for this trial, participants must be adults aged 65 to 74 with a specific type of NSCLC that has been surgically removed but did not respond fully to previous treatments. They should also be in good overall health, as indicated by a performance status score. Candidates with certain health conditions, such as uncontrolled HIV or specific cancer types, will not be eligible. If a person joins the trial, they can expect to receive regular monitoring and support from the research team throughout the study. It's important to know that this trial is currently recruiting participants, so interested individuals should discuss their options with their healthcare provider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• The main inclusion criteria include but are not limited to the following:
• • Has histologically/cytologically confirmed diagnosis of previously untreated and pathologically confirmed resectable Stage II, IIIA, or IIIB (N2) non-small cell lung cancer (NSCLC) \[American Joint Committee on Cancer (AJCC) 8th Edition\]
• • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before the first dose of study intervention
• • Participants who have not achieved a pathological complete response (pCR) following completion of neoadjuvant chemotherapy and pembrolizumab followed by surgery will be eligible
• • Confirmation that epidermal growth factor receptor (EGFR)-directed therapy is not indicated as primary therapy (documentation of absence of tumor-activating EGFR mutations \[eg, DEL19 or L858R\])
• • Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART)
• • Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization
• • Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
• Exclusion Criteria:
• The main exclusion criteria include but are not limited to the following:
• • Diagnosis of SCLC or, for mixed tumors, presence of small cell elements, or has a neuroendocrine tumor with large-cell components, or a sarcomatoid carcinoma, or a pancoast tumor
• • Documentation by local test report indicating presence of anaplastic lymphoma kinase (ALK) gene rearrangements
• • Received prior neoadjuvant therapy for their current NSCLC diagnosis
• • Received prior therapy with an anti-programmed cell death 1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell-death ligand 2 (PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein \[CTLA-4\], OX-40, CD137)
• • Received prior systemic anticancer therapy including investigational agents other than what is specified in this protocol
• • Received prior treatment with a cancer vaccine
• • Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
• • Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention