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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMerck Sharp & Dohme LLC

About this trial

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 criteria

Qualifiers

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.

Tumor tissue sample has a demonstrated presence of KRAS G12C mutation and an evaluable PD-L1 status result.

Disqualifiers

Has a diagnosis of small cell lung cancer or mixed tumors with small cell elements.

Has a gastrointestinal disorder affecting absorption or is unable to swallow orally administered medication.

Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease.

Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.

Trial design

Treatments tested in this trial

  • Calderasib
  • Durvalumab
  • Placebo to MK-1084

Treatment groups

310 Participants
are divided into 2 treatment groups

Sponsors and collaborators