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)
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.
Arms & interventions
- DrugCalderasib
Tablet for oral administration.
- BiologicalDurvalumab
Solution for intravenous (IV) infusion.
- OtherPlacebo to MK-1084
Placebo to MK-1084.
Outcome measures
Primary
Progression-Free Survival (PFS)
PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first.
Time frame: Up to approximately 6 years
Secondary
Overall Survival (OS)
Time frame: Up to approximately 9 years
Number of Participants Who Experience an Adverse Events (AEs)
Time frame: Up to approximately 9 years
Number of Participants Who Discontinue Study Treatment Due to an AE
Time frame: Up to approximately 9 years
Objective Response Rate (ORR)
Time frame: Up to approximately 9 years
Duration of Response (DOR)
Time frame: Up to approximately 9 years
Distant Metastasis-Free Survival (DMFS)
Time frame: Up to approximately 9 years
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS)/Quality of Life (QoL) (Items 29 & 30) Combined Score
Time frame: Baseline and up to approximately 9 years
Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score
Time frame: Baseline and up to approximately 9 years
Change from Baseline in Role Functioning (EORTC QLQ-C30 Items 6 & 7) Combined Score
Time frame: Baseline and up to approximately 9 years
Eligibility criteria
Study locations (1)
NHO Revive Research Institute LLC ( Site 0118)
Lincoln, Nebraska, 68506