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Combining pembrolizumab with intismeran autogene for non-small cell lung cancer 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)

Phase 3 Interventional Merck Sharp & Dohme LLC · NCT06623422

This study is testing if a new combination of a gene therapy and a cancer drug can help people with non-small cell lung cancer stay cancer-free after surgery.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment680 (estimated)
Ages18 Years and up
SexAll
SponsorMerck Sharp & Dohme LLC Industry-sponsored
Drugs / interventionspembrolizumab, chemotherapy, radiation
Locations231 sites (Gilbert, Arizona and 230 other locations)
Trial IDNCT06623422 on ClinicalTrials.gov

What this trial studies

This study aims to determine if the combination of intismeran autogene and pembrolizumab can prolong cancer-free survival in patients with non-small cell lung cancer (NSCLC) after surgery, compared to a placebo with pembrolizumab. Participants will be those who did not achieve a complete response to neoadjuvant treatment prior to surgery. The study will assess the effectiveness of this combination therapy in preventing cancer recurrence in patients with resectable Stage II, IIIA, or IIIB NSCLC. The trial is interventional and is in Phase 3.

Who should consider this trial

Good fit: Ideal candidates are individuals with resectable Stage II, IIIA, or IIIB non-small cell lung cancer who did not achieve a complete response after neoadjuvant treatment.

Not a fit: Patients with tumors that have activating EGFR mutations or those who have achieved a pathological complete response after neoadjuvant treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the chances of remaining cancer-free for patients with non-small cell lung cancer.

How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches, indicating potential for success in this novel combination.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Gilbert, Arizona and 230 other locations

+181 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 → Find more trials like this →
Conditions Carcinoma, Non-Small-Cell LungProgrammed Cell Death-1Programmed Cell Death 1 Ligand 1Programmed Cell Death 1 Ligand 2Individualized neoantigen therapy
Last reviewed 2026-06-13 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.