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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Carcinoma, Non-Small-Cell Lung

In brief

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 to know if giving intismeran autogene and pembrolizumab after surgery can help prevent the cancer from coming back in people with non-small cell lung cancer (NSCLC) whose tumors did not respond completely to treatment before surgery (neoadjuvant treatment).

Key facts

Study ID

NCT06623422

Run by

Merck Sharp & Dohme LLC

People needed

680

Starts

2024-10-21

Expected to finish

2038-01-26

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The Blavatnik Family- Chelsea Medical Center at Mount Sinai ( Site 0216) — New York, New York, United States (enrolling)
• Providence St. Jude Medical Center ( Site 0106) — Fullerton, California, United States (enrolling)
• VA Long Beach Healthcare System ( Site 0199) — Long Beach, California, United States (enrolling)
• Banner MD Anderson Cancer Center ( Site 0181) — Gilbert, Arizona, United States (enrolling)
• UCLA Jonsson Comprehensive Cancer Center ( Site 0135) — Los Angeles, California, United States (enrolling)
• UCSF Medical Center at Mission Bay ( Site 0178) — San Francisco, California, United States (enrolling)
• University of Colorado Anschutz Medical Campus ( Site 0151) — Aurora, Colorado, United States (enrolling)
• UCHealth Memorial Hospital Central ( Site 0125) — Colorado Springs, Colorado, United States (enrolling)
• Banner MD Anderson Cancer Center at North Colorado Medical Center ( Site 0207) — Greeley, Colorado, United States (enrolling)
• The University of Arizona Cancer Center - North Campus ( Site 0163) — Tucson, Arizona, United States (enrolling)
• Yale University School of Medicine ( Site 0201) — New Haven, Connecticut, United States (enrolling)
• Eastern CT Hematology & Oncology Associates ( Site 0202) — Norwich, Connecticut, United States (enrolling)
• The Oncology Institute of Hope and Innovation - Fort Lauderdale ( Site 0156) — Fort Lauderdale, Florida, United States (enrolling)
• Miami Cancer Institute at Baptist Health, Inc. ( Site 0214) — Miami, Florida, United States (enrolling)
• Beacon Cancer Care ( Site 0127) — Post Falls, Idaho, United States (enrolling)
• The University of Chicago Medical Center ( Site 0118) — Chicago, Illinois, United States (enrolling)
• Franciscan Health ( Site 0219) — Indianapolis, Indiana, United States (enrolling)
• Maryland Oncology Hematology (MOH) ( Site 8102) — Rockville, Maryland, United States (enrolling)
• Massachusetts General Hospital ( Site 0136) — Boston, Massachusetts, United States (enrolling)
• Dana Farber Cancer Hospital ( Site 0155) — Boston, Massachusetts, United States (enrolling)
• Centura Health - St. Anthony North Health Campus ( Site 0189) — Westminster, Colorado, United States (enrolling)
• USC Norris Comprehensive Cancer Center ( Site 0205) — Los Angeles, California, United States (enrolling)
• Roswell Park Cancer Institute ( Site 0184) — Buffalo, New York, United States (enrolling)
• Hematology-Oncology Associates of CNY ( Site 0164) — East Syracuse, New York, United States (enrolling)
• Icahn School of Medicine at Mount Sinai ( Site 0116) — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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