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Clinical Trials in Ireland / NCT06623422
Recruiting Phase 3

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

NCT06623422 · tracked via the Priya Life Science Ireland tracker
Sponsor
Merck Sharp & Dohme LLC
Phase
Phase 3
Started
2024-10-21
Last updated
2026-08-27

Condition(s) studied

Carcinoma, Non-Small-Cell Lung

Investigational drug(s) / intervention(s)

PembrolizumabCisplatinCarboplatinPemetrexedGemcitabinePaclitaxelIntismeran autogenePlacebo

Pembrolizumab: IV Infusion

Cisplatin: IV infusion

Carboplatin: IV infusion

Pemetrexed: IV infusion

Gemcitabine: IV infusion

Paclitaxel: IV infusion

Intismeran autogene: IM injection

Placebo: IM injection

Study 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 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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 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 Criteria: 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

Primary outcome measure(s)

Trial sites (241)

FacilityCityRegionStatus
Banner MD Anderson Cancer Center ( Site 0181) Gilbert Arizona Recruiting
The University of Arizona Cancer Center - North Campus ( Site 0163) Tucson Arizona Recruiting
Providence St. Jude Medical Center ( Site 0106) Fullerton California Recruiting
VA Long Beach Healthcare System ( Site 0199) Long Beach California Recruiting
USC Norris Comprehensive Cancer Center ( Site 0205) Los Angeles California Recruiting
UCLA Jonsson Comprehensive Cancer Center ( Site 0135) Los Angeles California Recruiting
UCSF Medical Center at Mission Bay ( Site 0178) San Francisco California Recruiting
University of Colorado Anschutz Medical Campus ( Site 0151) Aurora Colorado Recruiting
UCHealth Memorial Hospital Central ( Site 0125) Colorado Springs Colorado Recruiting
Banner MD Anderson Cancer Center at North Colorado Medical Center ( Site 0207) Greeley Colorado Recruiting
Centura Health - St. Anthony North Health Campus ( Site 0189) Westminster Colorado Recruiting
Yale University School of Medicine ( Site 0201) New Haven Connecticut Recruiting
Eastern CT Hematology & Oncology Associates ( Site 0202) Norwich Connecticut Recruiting
The Oncology Institute of Hope and Innovation - Fort Lauderdale ( Site 0156) Fort Lauderdale Florida Recruiting
Miami Cancer Institute at Baptist Health, Inc. ( Site 0214) Miami Florida Recruiting
Beacon Cancer Care ( Site 0127) Post Falls Idaho Recruiting
The University of Chicago Medical Center ( Site 0118) Chicago Illinois Recruiting
Franciscan Health ( Site 0219) Indianapolis Indiana Recruiting
Maryland Oncology Hematology (MOH) ( Site 8102) Rockville Maryland Recruiting
Massachusetts General Hospital ( Site 0136) Boston Massachusetts Recruiting
Dana Farber Cancer Hospital ( Site 0155) Boston Massachusetts Recruiting
Ellis Fischel Cancer Center ( Site 0133) Columbia Missouri Completed
Lake Regional Hospital-Cancer Center ( Site 0123) Osage Beach Missouri Completed
Roswell Park Cancer Institute ( Site 0184) Buffalo New York Recruiting
Hematology-Oncology Associates of CNY ( Site 0164) East Syracuse New York Recruiting
The Blavatnik Family- Chelsea Medical Center at Mount Sinai ( Site 0216) New York New York Recruiting
Icahn School of Medicine at Mount Sinai ( Site 0116) New York New York Recruiting
Memorial Sloan Kettering Cancer Center ( Site 0137) New York New York Recruiting
SUNY Upstate Cancer Center ( Site 0140) Syracuse New York Recruiting
Montefiore Medical Center ( Site 0160) The Bronx New York Recruiting
Westchester Medical Center ( Site 0196) Valhalla New York Recruiting
Novant Health Weisiger Cancer Insititute ( Site 0266) Charlotte North Carolina Recruiting
Novant Health Forsyth Medical Center ( Site 0166) Winston-Salem North Carolina Recruiting
University of Cincinnati Medical Center ( Site 0119) Cincinnati Ohio Recruiting
Good Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center ( Site 0217) Corvallis Oregon Recruiting
St. Lukes Hospital and Health Network ( Site 0186) Bethlehem Pennsylvania Recruiting
Tennessee Oncology, PLLC - Chattanooga Downtown ( Site 0315) Chattanooga Tennessee Recruiting
Thompson Cancer Survival Center ( Site 0168) Knoxville Tennessee Recruiting
Elliston Place Medical Oncology & Hematology ( Site 0215) Nashville Tennessee Recruiting
Texas Oncology - DFW ( Site 8103) Dallas Texas Recruiting

+ 201 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06623422 on ClinicalTrials.gov ↗ ← All trials in Ireland