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A Study of V940/Placebo + Pembrolizumab and Chemotherapy in Metastatic Squamous Non-Small Cell Lung Cancer (V940-013)
Sponsor: Merck Sharp & Dohme LLC
Summary
Researchers want to know if V940 (the study treatment) given with pembrolizumab and chemotherapy can treat metastatic treatment-naive squamous non-small cell lung cancer (NSCLC). V940 is designed to help a person's immune system attack their specific cancer. The goal of this study is to learn if people who receive V940 with pembrolizumab and chemotherapy live longer overall and without the cancer growing or spreading compared to people who receive placebo with pembrolizumab and chemotherapy. A placebo looks like the study treatment but has no study treatment in it. Using a placebo helps researchers better understand the effects of the study treatment.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
180
Start Date
2025-12-12
Completion Date
2031-05-06
Last Updated
2026-03-30
Healthy Volunteers
No
Conditions
Interventions
V940
1 mg Intramuscular (IM) Injection
Pembrolizumab
200 mg IV Infusion
Carboplatin
Area Under the Curve (AUC) 6 (mg/mL/min) IV Infusion
Paclitaxel
200 mg/m\^2 IV Infusion
Nab-paclitaxel
100 mg/m\^2 IV Infusion
Placebo
Placebo matched to V940 IM injection
Locations (25)
Valley Health Systems - Ridgewood Campus ( Site 0010)
Paramus, New Jersey, United States
Cleveland Clinic - Ohio ( Site 0016)
Cleveland, Ohio, United States
Tennessee Oncology, PLLC - Elliston Place Plaza Medical Oncology & Hematology ( Site 9000)
Nashville, Tennessee, United States
Virginia Cancer Specialists ( Site 0003)
Fairfax, Virginia, United States
Hospital Italiano de Buenos Aires ( Site 0200)
Ciudad Autonoma de Buenos Aires., Buenos Aires, Argentina
Instituto Alexander Fleming ( Site 0201)
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0205)
Mar del Plata, Buenos Aires, Argentina
Clinica Adventista Belgrano ( Site 0206)
Caba., Buenos Aires F.D., Argentina
Fundacion Estudios Clinicos ( Site 0207)
Rosario, Santa Fe Province, Argentina
Sanatorio Parque ( Site 0203)
Rosario, Santa Fe Province, Argentina
Westmead Hospital ( Site 0400)
Westmead, New South Wales, Australia
One Clinical Research ( Site 0402)
Nedlands, Western Australia, Australia
Centro de Estudios Clínicos SAGA ( Site 0307)
Santiago, Region M. de Santiago, Chile
FALP ( Site 0300)
Santiago, Region M. de Santiago, Chile
Bradfordhill ( Site 0301)
Santiago, Region M. de Santiago, Chile
Bradford Hill Norte ( Site 0308)
Antofagasta, Chile
National Cancer Center ( Site 0504)
Goyang-si, Kyonggi-do, South Korea
Seoul National University Bundang Hospital ( Site 0500)
Seongnam-si, Kyonggi-do, South Korea
Chungbuk National University Hospital-Internal medicine ( Site 0501)
Cheongju-si, North Chungcheong, South Korea
Asan Medical Center ( Site 0503)
Seoul, South Korea
Samsung Medical Center ( Site 0502)
Seoul, South Korea
National Cheng Kung University Hospital ( Site 0601)
Tainan, Taiwan
Mackay Memorial Hospital ( Site 0604)
Taipei, Taiwan
Chang Gung Medical Foundation-Linkou Branch ( Site 0605)
Taoyuan District, Taiwan
Hacettepe Universitesi Tıp Fakultesi ( Site 1400)
Ankara, Turkey (Türkiye)