V940-013 - 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).

Studio Clinico

Patologia: Neoplasie del polmone

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: Sì

Fase di studio: II Randomizzato

Linee di trattamento: Prima linea

Criteri di inclusione: 

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.

Criteri di esclusione: 

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.

Trattamento sperimentale: 

- Intismeran Autogene + Pembrolizumab + Chemo
- Placebo + Pembrolizumab + Chemo

Trattamento di controllo: 

-

Centri partecipanti

Nord Italia

Centro Italia

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2025-520902-37-00

Data di inserimento: 15.06.2026

Promotore

Merck Sharp & Dohme LLC

Principal Investigator ITALIA

Riferimento: Dr. - -

Telefono: 00000

Email: na@na.it

Localita: -