A Clinical Trial of Calderasib (MK-1084) and Durvalumab in People With Non-Small Cell Lung Cancer (MK-1084-015/KANDLELIT-015)

Part of paid clinical trials in Lincoln, Nebraska.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT07554339
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Apr 28, 2026
Start date
Jun 18, 2026
Status verified
Aug 2026
Primary completion
Dec 15, 2032
Completion
Aug 17, 2037

Study Design

Enrollment
310 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Calderasib + Durvalumab
    Participants will receive calderasib and durvalumab.
  • Active Comparator: Placebo + Durvalumab
    Participants will receive placebo to calderasib and durvalumab.

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: Up to approximately 6 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
NHO Revive Research Institute LLC ( Site 0118)LincolnNebraska68506
Study Coordinator
402-484-4900
New York Oncology Hematology P.C ( Site 9000)AlbanyNew York12206
Study Coordinator
518-489-0044

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By research site
NHO Revive Research Institute LLC· Lincoln, NENew York Oncology Hematology P.C· Albany, NY

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