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 study on Lung Cancer Non-Small Cell Lung Cancer

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
study ends around
Principal Investigator
by Michael Cheng
Headshot of Michael Cheng
Michael Cheng

Description

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).

Official Title

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)

Keywords

Carcinoma, Non-Small-Cell Lung, Programmed Cell Death-1 (PD1, PD-1), Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1), Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2), Individualized neoantigen therapy (INT), Non-Small-Cell Lung Carcinoma, Paclitaxel, Cisplatin, Carboplatin, Gemcitabine, Pembrolizumab, Pemetrexed, Intismeran autogene, Pembrolizumab + Intismeran autogene

Eligibility

You can join if…

Open to people ages 18 years and up

The main inclusion criteria include but are not limited to the following:

  • 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

You CAN'T join if...

The main exclusion criteria include but are not limited to the following:

  • 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

Locations

  • UCSF Medical Center at Mission Bay ( Site 0178) accepting new patients
    San Francisco California 94158 United States
  • Providence St. Jude Medical Center ( Site 0106) accepting new patients
    Fullerton California 92835 United States

Lead Scientist at UCSF

  • Michael Cheng
    Dr. Michael L. Cheng is an academic medical oncologist and Assistant Professor at the University of California, San Francisco (UCSF), where he leads clinical and translational research focused on advancing discoveries in cancer genomics and developing improved therapies for thoracic malignancies, especially Non-Small Cell Lung Cancer (NSCLC). Dr. Cheng received his M.D.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Merck Sharp & Dohme LLC
Links
Merck Clinical Trials Information Plain Language Summary
ID
NCT06623422
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 680 study participants
Last Updated
Contact us about this trial