Recruiting

INTerpath-13V940 and Pembrolizumab for Metastatic Squamous NSCLC

Study Aim

This study aims to evaluate the effectiveness and safety of combining V940 and Pembrolizumab in treating adults with metastatic squamous non-small cell lung cancer.

What is being tested

V940

+ Pembrolizumab

+ Carboplatin

BiologicalDrugOther

Who is being recruted

Over 18 Years

+27 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2

Interventional

Study Start: December 2025

See protocol details

Summary

Principal SponsorMerck Sharp & Dohme LLC

Study ContactToll Free Number

Last updated: March 25, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: December 12, 2025

Actual date on which the first participant was enrolled.

This study is focusing on finding new ways to treat a type of lung cancer called metastatic squamous non-small cell lung cancer (NSCLC). It targets people who have not yet received any treatment for their cancer. The researchers are testing a combination of drugs, including a new one called V940, along with pembrolizumab and standard chemotherapy. V940 is designed to help the body's immune system attack the cancer more effectively. The main aim is to see if this combination helps patients live longer without their cancer getting worse, compared to using pembrolizumab and chemotherapy with a placebo. Participants in this study will be randomly assigned to receive either the combination of V940, pembrolizumab, and chemotherapy, or a placebo with pembrolizumab and chemotherapy. The treatments are administered through medical procedures as per standard care. The study carefully measures how long participants live and whether the cancer grows or spreads during the trial. The use of a placebo helps ensure that any benefits seen are due to V940. While potential benefits include a longer life and delayed cancer progression, all medications can have side effects, which will be monitored closely during the study.

Official TitleA 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)

NCT07221474

Principal SponsorMerck Sharp & Dohme LLC

Study ContactToll Free Number

Last updated: March 25, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

180 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

10 inclusion criteria required to participate

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

Has adequate organ function

Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)

Show More Criteria

17 exclusion criteria prevent from participating

Has known additional malignancy that is progressing or has required active treatment within the past 3 years

Has severe hypersensitivity (≥Grade 3) to V940, pembrolizumab, or any of the protocol allowed chemotherapy agents and/or any of their excipients

Has a history of stem cell/solid organ transplant

Has active autoimmune disease that has required systemic treatment in the past 2 years

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Induction phase: Participants receive pembrolizumab 400 mg intravenous (IV) infusion on Day 1 of a six week cycle plus a platinum doublet chemotherapy regimen (carboplatin area under the curve (AUC) 6 mg/mL/min IV infusion every 3 weeks (Q3W) × 2 doses combined with either paclitaxel 200 mg/m\^2 IV infusion Q3W × 2 doses OR nab paclitaxel 100 mg/m\^2 IV infusion weekly × 6 doses). V940 1 mg intramuscular (IM) injection is administered on Days 1 and 22 of Cycle 2 Induction (Q3W) for up to 2 doses. Maintenance phase: Participants receive pembrolizumab 400 mg IV infusion on Day 1 every 6 weeks (Q6W) for up to 15 doses. V940 1 mg IM injection is administered on Days 1 and 22 (Q3W) for up to 7 doses during maintenance.

Group II

Experimental

Induction phase: Participants receive pembrolizumab 400 mg intravenous (IV) infusion on Day 1 of a six week cycle plus a platinum doublet chemotherapy regimen (carboplatin area under the curve (AUC) 6 mg/mL/min IV infusion every 3 weeks (Q3W) × 2 doses combined with either paclitaxel 200 mg/m\^2 IV infusion Q3W × 2 doses OR nab paclitaxel 100 mg/m\^2 IV infusion weekly × 6 doses). Placebo intramuscular (IM) injection is administered on Days 1 and 22 of Cycle 2 Induction (Q3W) for up to 2 doses. Maintenance phase: Participants receive pembrolizumab 400 mg IV infusion on Day 1 every 6 weeks (Q6W) for up to 15 doses. Placebo IM injection is administered on Days 1 and 22 (Q3W) for up to 7 doses during maintenance.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 23 locations

Recruiting

Valley Health Systems - Ridgewood Campus ( Site 0010)

Paramus, United StatesOpen Valley Health Systems - Ridgewood Campus ( Site 0010) in Google Maps

Recruiting

Cleveland Clinic - Ohio ( Site 0016)

Cleveland, United States

Recruiting

Tennessee Oncology, PLLC - Elliston Place Plaza Medical Oncology & Hematology ( Site 9000)

Nashville, United States

Recruiting

Virginia Cancer Specialists ( Site 0003)

Fairfax, United States

Recruiting

23 Study Centers