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)
Summary
Researchers want to know if intismeran autogene (the study treatment) given with pembrolizumab and chemotherapy can treat metastatic treatment-naive squamous non-small cell lung cancer (NSCLC). Intismeran autogene 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 intismeran autogene 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.
Arms & interventions
- BiologicalIntismeran Autogene
1 mg Intramuscular (IM) Injection
- BiologicalPembrolizumab
200 mg IV Infusion
- DrugCarboplatin
Area Under the Curve (AUC) either 6 or 5 (mg/mL/min) IV Infusion
- DrugPaclitaxel
200 or 175 mg/m\^2 IV Infusion
- DrugNab-paclitaxel
100 mg/m\^2 IV Infusion
- OtherPlacebo
Placebo matched to Intismeran Autogene IM injection
Outcome measures
Primary
Progression Free Survival (PFS)
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1). PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review (BICR) will be presented.
Time frame: Up to ~32 months
Overall Survival (OS)
OS, defined as the time from randomization to death due to any cause. OS will be presented.
Time frame: Up to ~42 months
Secondary
Overall Response Rate (ORR)
Time frame: Up to ~26 months
Duration of Response (DOR)
Time frame: Up to ~42 months
Number of Participants who Experience an Adverse Event (AE)
Time frame: Up to ~42 months
Number of Participants who Discontinue Study Intervention Due to an AE
Time frame: Up to ~24 months
Eligibility criteria
Study locations (7)
Moffitt Cancer Center ( Site 0021)
Tampa, Florida, 33612
Washington University School of Medicine ( Site 0024)
St Louis, Missouri, 63110
Valley Health Systems - Ridgewood Campus ( Site 0010)
Paramus, New Jersey, 07652
Cleveland Clinic - Ohio ( Site 0016)
Cleveland, Ohio, 44195
Tennessee Oncology, PLLC - Elliston Place Plaza Medical Oncology & Hematology ( Site 9000)
Nashville, Tennessee, 37203
Texas Oncology - Central/South Texas ( Site 8002)
Austin, Texas, 78745
Virginia Cancer Specialists ( Site 0003)
Fairfax, Virginia, 22031