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

Description

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).

Conditions

Carcinoma, Non-Small-Cell Lung

Talk to us

Study Overview

On this page

Study Details

Study overview

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).

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)

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

Condition
Carcinoma, Non-Small-Cell Lung
Intervention / Treatment

-

Contacts and Locations

Fullerton

Providence St. Jude Medical Center ( Site 0106), Fullerton, California, United States, 92835

Colorado Springs

UCHealth Memorial Hospital Central ( Site 0125), Colorado Springs, Colorado, United States, 80909

Post Falls

Beacon Cancer Care ( Site 0127), Post Falls, Idaho, United States, 83854

Chicago

The University of Chicago Medical Center ( Site 0118), Chicago, Illinois, United States, 60637

Osage Beach

Lake Regional Hospital-Cancer Center ( Site 0123), Osage Beach, Missouri, United States, 65065

Bronx

Montefiore Medical Center ( Site 0160), Bronx, New York, United States, 10461

East Syracuse

Hematology-Oncology Associates of CNY ( Site 0164), East Syracuse, New York, United States, 13057

New York

Icahn School of Medicine at Mount Sinai ( Site 0116), New York, New York, United States, 10029

New York

Memorial Sloan Kettering Cancer Center ( Site 0137), New York, New York, United States, 10065

Cincinnati

University of Cincinnati Medical Center ( Site 0119), Cincinnati, Ohio, United States, 45219

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Merck Sharp & Dohme LLC,

Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

2038-01-26