Status:
RECRUITING
A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009)
Lead Sponsor:
Merck Sharp & Dohme LLC
Collaborating Sponsors:
ModernaTX, Inc.
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The goal of this study is to learn if people who receive intismeran autogene and pembrolizumab after surgery are cancer-free longer than people who receive placebo and pembrolizumab. Researchers want ...
Eligibility Criteria
Inclusion
- The main inclusion criteria include but are not limited to the following:
- Has histologically/cytologically confirmed diagnosis of previously untreated and pathologically confirmed resectable clinical 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
- The main exclusion criteria include but are not limited to the following:
- Diagnosis of small cell lung cancer (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
Key Trial Info
Start Date :
October 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 26 2038
Estimated Enrollment :
680 Patients enrolled
Trial Details
Trial ID
NCT06623422
Start Date
October 21 2024
End Date
January 26 2038
Last Update
March 11 2026
Active Locations (225)
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1
Banner MD Anderson Cancer Center ( Site 0181)
Gilbert, Arizona, United States, 85234
2
The University of Arizona Cancer Center - North Campus ( Site 0163)
Tucson, Arizona, United States, 85719
3
Providence St. Jude Medical Center ( Site 0106)
Fullerton, California, United States, 92835
4
VA Long Beach Healthcare System ( Site 0199)
Long Beach, California, United States, 90822