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

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.

Trial Details

NCT ID
NCT07554339
Phase
PHASE3
Sponsor
Merck Sharp & Dohme LLC
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • Calderasib
  • Durvalumab
  • Placebo to MK-1084
Locations (sample)
  • Lincoln, Nebraska, United States|40.8,-96.66696
  • Daegu, Taegu-Kwangyokshi, South Korea|35.87028,128.59111
  • Tainan, Taiwan|22.99083,120.21333
  • Odesa, Odesa Oblast, Ukraine|46.48572,30.74383
  • Vinnytsia, Vinnytsia Oblast, Ukraine|49.2322,28.46871

Key Eligibility 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…
  • 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 (P…

For full eligibility, visit ClinicalTrials.gov.

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