Home › Trials › NCT07221474

Intismeran autogene plus pembrolizumab and chemotherapy for metastatic squamous non-small cell lung cancer

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of V940 in Combination With Pembrolizumab and Chemotherapy as First-Line Treatment for Participants With Metastatic Squamous NSCLC (INTerpath-013)

PHASE2 · Merck Sharp & Dohme LLC · NCT07221474

This trial will test whether adding intismeran autogene to pembrolizumab and chemotherapy helps people with treatment‑naive metastatic squamous non‑small cell lung cancer live longer and keep their cancer from growing.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment180 (estimated)
Ages18 Years and up
SexAll
SponsorMerck Sharp & Dohme LLC (industry)
Drugs / interventionspembrolizumab, chemotherapy, radiation, prednisone
Locations43 sites (St Louis, Missouri and 42 other locations)
Trial IDNCT07221474 on ClinicalTrials.gov

What this trial studies

This Phase 2, randomized, placebo‑controlled trial compares intismeran autogene combined with pembrolizumab and standard chemotherapy versus placebo with pembrolizumab and chemotherapy in patients with treatment‑naive metastatic squamous NSCLC. Participants must have measurable disease and provide a recent, non‑irradiated tumor tissue sample for characterization. The trial measures clinical outcomes including overall survival and progression‑free survival to see if the personalized immunotherapy adds benefit over the current pembrolizumab‑plus‑chemo regimen. Treatment is administered at participating clinical sites with scheduled follow‑up for disease assessments and safety monitoring.

Who should consider this trial

Good fit: Adults with newly diagnosed (treatment‑naive) metastatic squamous NSCLC who have measurable disease, an available non‑irradiated tumor sample, and recovered from prior therapy‑related side effects are ideal candidates.

Not a fit: Patients with small‑cell components in their tumor, prior systemic treatment for metastatic disease, lack of measurable disease, or uncontrolled medical conditions are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, adding intismeran autogene could extend overall survival and delay cancer progression beyond what pembrolizumab plus chemotherapy alone achieves.

How similar studies have performed: Checkpoint inhibitors plus chemotherapy are an established standard in this setting, but personalized cancer vaccines like intismeran autogene are experimental and prior studies have shown mixed early signals rather than definitive success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

Inclusion Criteria include, but are not limited to:

* Has a histologically or cytologically confirmed diagnosis of squamous non-small cell lung cancer (NSCLC) (Stage IV: M1a, M1b, M1c1, M1c2, AJCC Staging Manual, Version 9). NOTE: Mixed tumors will be characterized by the predominant cell type; however, small cell elements are not permitted.
* Has measurable disease per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by the local site investigator/radiology
* Has provided a tissue sample that is collected either at the time of or after the diagnosis of metastatic disease AND is from a site not previously irradiated
* Adverse events (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
* Hepatitis B surface antigen (HBsAg) positive participants 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. NOTE: Participants must have completed curative antiviral therapy at least 4 weeks prior to randomization
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization
* Has a life expectancy of at least 3 months
* Has adequate organ function

Exclusion Criteria:

Exclusion Criteria include, but are not limited to:

* Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
* Has received prior treatment with a cancer vaccine, including another personalized cancer vaccine (PCV)
* Has received prior systemic anticancer therapy for their metastatic NSCLC
* Has received prior therapy with an anti-programmed cell death 1 protein (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-programmed cell death ligand 2 (anti-PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor. NOTE: Prior treatment with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent in the neoadjuvant or adjuvant setting for nonmetastatic NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC
* Has received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
* Has received radiation therapy to the lung that is \>30 gray within 6 months of start of study intervention
* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed
* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
* Has a 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 intervention
* Has known additional malignancy that is progressing or has required active treatment within the past 3 years
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Has severe hypersensitivity (≥Grade 3) to V940, pembrolizumab, or any of the protocol allowed chemotherapy agents and/or any of their excipients
* Has active autoimmune disease that has required systemic treatment in the past 2 years
* Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
* Has active infection requiring systemic therapy
* Has a history of stem cell/solid organ transplant
* Has not adequately recovered from major surgery or has ongoing surgical complications

Where this trial is running

St Louis, Missouri and 42 other locations

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: Squamous 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.