A Phase 3, Randomized, Placebo-Controlled Study of Adjuvant Intismeran Autogene Plus Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) or Intismeran Autogene Monotherapy Versus Placebo in Participants With Completely Resected High-Risk Stage I Non-Small Cell Lung Cancer (INTerpath-014)
Summary
Researchers are looking for new ways to treat high-risk, localized non-small cell lung cancer (NSCLC) that has been removed with surgery. People with high-risk, localized NSCLC are often treated with surgery. Researchers want to learn if participants can receive 1 or 2 trial treatments to help prevent NSCLC from coming back after surgery. One trial medicine is intismeran (also called V940/mRNA-4157) and the other is subcutaneous pembrolizumab (also called SC pembrolizumab and MK-3475A). Intismeran is designed to help a person's immune system attack their specific cancer. SC pembrolizumab is an immunotherapy treatment which helps the immune system fight cancer. The main purpose of this study is to evaluate whether adjuvant intismeran autogene (V940) in combination with SC pembrolizumab and berahyaluronidase alfa (MK-3475A) or intismeran monotherapy improves disease-free survival (DFS) compared with placebo in participants with completely resected high-risk Stage I NSCLC.
Arms & interventions
- BiologicalIntismeran
IM injection
- BiologicalPembrolizumab coformulated with berahyaluronidase alfa
SC injection
- OtherPlacebo
IM injection
Outcome measures
Primary
Disease-Free Survival (DFS) as Assessed by Blinded Independent Central Review (BICR) in Participants With Nonsquamous Non-Small Cell Lung Cancer (NSCLC) in Arm A and Arm C
DFS is defined as the time from randomization to any recurrence (local, locoregional, regional, or distant) by BICR, or death due to any cause, whichever occurs first.
Time frame: Up to approximately 98 months
Secondary
DFS as Assessed by BICR
Time frame: Up to approximately 98 months
Distant Metastasis-Free Survival (DMFS)
Time frame: Up to approximately 111 months
Overall Survival (OS)
Time frame: Up to approximately 123 months
Number Participants Who Experience an Adverse Events (AE)
Time frame: Up to approximately 144 months
Number of Participants Who Discontinue Study Treatment Due to an AE
Time frame: Up to approximately 144 months
Change From Baseline in European Organization for Research and Treatment (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Combined Global Health Status / Quality of Life (Items 29 & 30) Scale Combined Score
Time frame: Baseline and up to approximately 36 months
Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Score
Time frame: Baseline and up to approximately 36 months
Change From Baseline in Role Functioning (EORTC QLQ-C30 Items 6-7) Score
Time frame: Baseline and up to approximately 36 months
Eligibility criteria
Study locations (5)
Billings Clinic ( Site 3255)
Billings, Montana, 59101
NHO Revive Research Institute, LLC ( Site 3218)
Lincoln, Nebraska, 68506
Renown Regional Medical Center-Renown Health Medical Oncology ( Site 3207)
Reno, Nevada, 89502
Altru Health System ( Site 3254)
Grand Forks, North Dakota, 58201
The University of Tennessee Medical Center ( Site 3223)
Knoxville, Tennessee, 37920