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Combining Intismeran Autogene with Pembrolizumab for Non-small Cell Lung Cancer

A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator-Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants With Resected Stage II, IIIA, IIIB (N2) Non-small Cell Lung Cancer (INTerpath-002)

PHASE3 · Merck Sharp & Dohme LLC · NCT06077760

This study is testing if a new treatment combining intismeran autogene with pembrolizumab can help people who have had surgery for non-small cell lung cancer stay cancer-free longer than those who only receive pembrolizumab with a placebo.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment868 (estimated)
Ages18 Years and up
SexAll
SponsorMerck Sharp & Dohme LLC (industry)
Drugs / interventionspembrolizumab, chemotherapy, prednisone
Locations229 sites (Anchorage, Alaska and 228 other locations)
Trial IDNCT06077760 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of intismeran autogene combined with pembrolizumab compared to a placebo with pembrolizumab in patients who have undergone complete surgical resection of Stage II, IIIA, or IIIB non-small cell lung cancer (NSCLC). The primary goal is to determine if this combination improves disease-free survival (DFS) rates. Participants must have no evidence of disease prior to randomization and have received standard adjuvant chemotherapy. The study aims to provide insights into new treatment options for patients with this type of lung cancer.

Who should consider this trial

Good fit: Ideal candidates are patients who have undergone complete surgical resection of margin-negative Stage II, IIIA, or IIIB NSCLC and have received adjuvant chemotherapy.

Not a fit: Patients with active disease or those who have not undergone complete surgical resection will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve disease-free survival rates for patients with non-small cell lung cancer.

How similar studies have performed: Previous studies have shown promising results with similar immunotherapy approaches in treating non-small cell lung cancer.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

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

* Has undergone margin negative, completely resected non-small cell lung cancer (NSCLC), and has pathological Stage II, IIIA, IIIB (N2) squamous or nonsquamous tumor, node, metastasis (TNM) staging per American Joint Committee on Cancer (AJCC) Eighth Edition guidelines.
* Has no evidence of disease before randomization.
* Has received at least one dose of adjuvant treatment with standard of care platinum doublet chemotherapy.
* No more than 24 weeks have elapsed between surgical resection of curative intent and the first dose of pembrolizumab.
* 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.
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART).

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.
* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
* Received prior neoadjuvant therapy for their current NSCLC diagnosis.
* Received or is a candidate to receive radiotherapy for their current NSCLC diagnosis.
* Received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-PD-ligand 1 (L1), or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor.
* Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
* Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication.
* Known additional malignancy that is progressing or has required active treatment within the past 5 years.
* Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed.
* History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
* Active infection requiring systemic therapy.

Where this trial is running

Anchorage, Alaska and 228 other locations

+179 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Non-small Cell Lung Cancer

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.