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RecruitingPhase 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)

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests pembrolizumab with intismeran autogene (V940) or a placebo (a treatment with no active drug) after surgery. It is for people with non-small cell lung cancer whose cancer was not fully cleared by treatment before surgery. Researchers want to see if adding V940 keeps people cancer-free longer.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have newly diagnosed, previously untreated non-small cell lung cancer confirmed by tissue or cell tests. It must be stage II, IIIA, or IIIB (N2) and able to be removed by surgery.
  • Be fully active or able to do light work, as checked within 7 days before the first study dose.
  • Have cancer still found in the tissue removed during surgery after chemotherapy and pembrolizumab treatment.
  • Have test results showing no tumor changes in the EGFR gene that would make EGFR-targeted drugs the main treatment.
  • If you have HIV, it must be well controlled with HIV medicines.
  • If you test positive for hepatitis B, have taken antiviral medicine for at least 4 weeks. The virus must be too low to detect before assignment to a study group.
  • If you have had hepatitis C, the virus must be too low to detect at screening.

Who can't join

  • Have small cell lung cancer, a tumor with any small cell parts, a large-cell neuroendocrine tumor (a type involving hormone-making cells), sarcomatoid cancer, or a Pancoast tumor (at the top of the lung).
  • Have an ALK gene change called a rearrangement, shown by a local test.
  • Have already received treatment before surgery for your current lung cancer.
  • Have already received certain immune treatments targeting PD-1, PD-L1, PD-L2, or other proteins that control immune cells called T cells.
  • Have already received cancer drugs that travel through the body, including experimental drugs, other than those allowed in this study.
  • Have already received a cancer vaccine.
  • Have had radiation treatment within 2 weeks before starting study treatment, or have radiation side effects that need steroid medicines.
  • Have received a vaccine containing live or weakened germs within 30 days before the first study dose.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (54)

AZ

CA

CO

CT

FL

ID

IL

IN

MA

MD

MO

NC

NY

OH

OR

  • Good Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center ( Site 0217) · Corvallis, OR 97330Study Coordinator · Study contact · 541-768-4950More trials in Corvallis

PA

TN

TX

VA

WA