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RECRUITINGPhase 3INTERVENTIONAL

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

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)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

Who May Be Eligible (Plain English)

Who May Qualify: 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 weakened immune system 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 Who Should NOT Join This Trial: 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

BIOLOGICAL

Pembrolizumab

IV Infusion

DRUG

Cisplatin

IV infusion

DRUG

Carboplatin

IV infusion

DRUG

Pemetrexed

IV infusion

DRUG

Gemcitabine

IV infusion

DRUG

Paclitaxel

IV infusion

BIOLOGICAL

Intismeran autogene

IM injection

OTHER

Placebo

IM injection

Locations (20)

Banner MD Anderson Cancer Center ( Site 0181)
Gilbert, Arizona, United States
The University of Arizona Cancer Center - North Campus ( Site 0163)
Tucson, Arizona, United States
Providence St. Jude Medical Center ( Site 0106)
Fullerton, California, United States
VA Long Beach Healthcare System ( Site 0199)
Long Beach, California, United States
USC Norris Comprehensive Cancer Center ( Site 0205)
Los Angeles, California, United States
UCSF Medical Center at Mission Bay ( Site 0178)
San Francisco, California, United States
University of Colorado Anschutz Medical Campus ( Site 0151)
Aurora, Colorado, United States
UCHealth Memorial Hospital Central ( Site 0125)
Colorado Springs, Colorado, United States
Banner MD Anderson Cancer Center at North Colorado Medical Center ( Site 0207)
Greeley, Colorado, United States
Centura Health - St. Anthony North Health Campus ( Site 0189)
Westminster, Colorado, United States
Yale University School of Medicine ( Site 0201)
New Haven, Connecticut, United States
Eastern CT Hematology & Oncology Associates ( Site 0202)
Norwich, Connecticut, United States
The Oncology Institute of Hope and Innovation - Fort Lauderdale ( Site 0156)
Fort Lauderdale, Florida, United States
Miami Cancer Institute at Baptist Health, Inc. ( Site 0214)
Miami, Florida, United States
Beacon Cancer Care ( Site 0127)
Post Falls, Idaho, United States
The University of Chicago Medical Center ( Site 0118)
Chicago, Illinois, United States
Maryland Oncology Hematology (MOH) ( Site 8102)
Rockville, Maryland, United States
Massachusetts General Hospital ( Site 0136)
Boston, Massachusetts, United States
Dana Farber Cancer Hospital ( Site 0155)
Boston, Massachusetts, United States
Ellis Fischel Cancer Center ( Site 0133)
Columbia, Missouri, United States