A Study of Intismeran Autogene (V940) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002)
Phase 3
868
about 12 years
18+
68 sites in AK, AZ, CA +26
What this study is about
This trial is testing a treatment with intismeran autogene and pembrolizumab compared to placebo plus pembrolizumab for people who have non-small cell lung cancer. The goal is to see if the combination of intismeran autogene and pembrolizumab improves disease-free survival.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Placebo
- 2.Receive Intismeran autogene
- 3.Receive Pembrolizumab
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You may get a placebo/standard care, and you won't know which.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
pembrolizumab (Immune checkpoint inhibitor; blocks PD-1 to boost T-cell attack on cancer)
infusion
Primary: Disease- Free Survival (DFS)
Secondary: Change from Baseline in the EORTC QLQ-C30 Dyspnea (Item 8) Score on the EORTC QLQ-C30, Change from Baseline in the EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30, Change from Baseline in the EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30, Change from Baseline in the EORTC QLQ-LC24 Chest Pain (Item 40) Score on the EORTC QLQ-LC24, Change from Baseline in the EORTC QLQ-Lung Cancer Questionnaire (LC24) Coughing (Items 31 and 52) Combined Score on the EORTC QLQ-LC24, Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score, Distant Metastasis-Free Survival (DMFS), Number of Participants Who Discontinue Study Treatment Due to an AE
Oncology