A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator-Controlled Study of MK-1084 Plus Durvalumab Versus Placebo Plus Durvalumab in Participants With Locally Advanced, Unresected KRAS G12C-Mutant Non-Small Cell Lung Cancer Without Disease Progression Following Definitive Platinum-Based Chemoradiotherapy (KANDLELIT-015)
Merck Sharp & Dohme LLC
Summary
Researchers are looking for new ways to treat locally advanced non-small cell lung cancer (NSCLC) that is unresected and has a gene mutation called KRAS G12C. Researchers want to learn if calderasib (MK-1084) can be given with durvalumab, an immunotherapy, to treat NSCLC after chemotherapy and radiation therapy. The goal of this trial is to learn if participants who receive calderasib and durvalumab live longer without the cancer growing or spreading compared to participants who receive placebo and durvalumab.
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 a histological or cytological diagnosis of locally advanced, unresected Stage II (node-positive) to III non-small cell lung cancer (NSCLC) with predominantly nonsquamous histology. * Has completed definitive platinum-based concurrent chemoradiotherapy (CCRT) prior to enrollment, without disease progression. * Has provided a tumor tissue sample for central laboratory testing of Kirsten rat sarcoma G12C (KRAS G12C) status, programmed cell death ligand 1 (PD-L1) status, and biomarker research. *…
Interventions
- DrugCalderasib
Tablet for oral administration.
- BiologicalDurvalumab
Solution for intravenous (IV) infusion.
- OtherPlacebo to MK-1084
Placebo to MK-1084.
Locations (103)
- Low Country Cancer Care ( Site 0155)Savannah, Georgia
- Duly Healthcare ( Site 0158)Lisle, Illinois
- NHO Revive Research Institute LLC ( Site 0118)Lincoln, Nebraska
- New York Oncology Hematology P.C ( Site 9000)Albany, New York
- WakeMed Raleigh Campus ( Site 0144)Raleigh, North Carolina
- Virginia Cancer Specialists ( Site 0114)Fairfax, Virginia