A Phase 3 Randomized Double-blind Study of Adjuvant Pembrolizumab With or Without V940 in Participants With Resectable Stage II to IIIB (N2) NSCLC Not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy (INTerpath-009)
Merck Sharp & Dohme LLC
Summary
The goal of this study is to learn if people who receive intismeran autogene and pembrolizumab after surgery are cancer-free longer than people who receive placebo and pembrolizumab. Researchers want to know if giving intismeran autogene and pembrolizumab after surgery can help prevent the cancer from coming back in people with non-small cell lung cancer (NSCLC) whose tumors did not respond completely to treatment before surgery (neoadjuvant treatment).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has histologically/cytologically confirmed diagnosis of previously untreated and pathologically confirmed resectable clinical Stage II, IIIA, or IIIB (N2) non-small cell lung cancer (NSCLC) \[American Joint Committee on Cancer (AJCC) 8th Edition\] * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before the first dose of study intervention * Participants who have not achieved a pathological complete response (pCR) following completion of neoadjuvant chem…
Interventions
- BiologicalPembrolizumab
IV Infusion
- DrugCisplatin
IV infusion
- DrugCarboplatin
IV infusion
- DrugPemetrexed
IV infusion
- DrugGemcitabine
IV infusion
- DrugPaclitaxel
IV infusion
- BiologicalIntismeran autogene
IM injection
- Other
Locations (231)
- Banner MD Anderson Cancer Center ( Site 0181)Gilbert, Arizona
- The University of Arizona Cancer Center - North Campus ( Site 0163)Tucson, Arizona
- Providence St. Jude Medical Center ( Site 0106)Fullerton, California
- VA Long Beach Healthcare System ( Site 0199)Long Beach, California
- USC Norris Comprehensive Cancer Center ( Site 0205)Los Angeles, California
- UCSF Medical Center at Mission Bay ( Site 0178)San Francisco, California