ClinicaliQ Trial Snapshot
- A Clinical Trial of Calderasib (MK-1084) and Durvalumab in People With Non-Small Cell Lung Cancer (MK-1084-015/KANDLELIT-015) — Recruiting • Phase III • Oncology • NCT07554339.
- What is being tested: The combination of calderasib (MK-1084), a KRAS G12C inhibitor, with durvalumab (an immunotherapy) in patients with locally advanced, unresected non-small cell lung cancer harbouring KRAS G12C mutations.
- Patient eligibility overview: The trial recruits patients with locally advanced NSCLC that has not undergone surgical resection and who have confirmed KRAS G12C gene mutations; specific performance status and organ function criteria apply as per standard trial protocols.
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- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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 Snapshot
- : 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. * Tumor tissue sample has a demonstrated presence of KRAS G12C mutation and an evaluable PD-L1 status result. * If human immunodeficiency virus (HIV)-infected, has well-controlled HIV on antiretroviral therapy (ART). * If hepatitis B surface antigen (HBsAg)-positive, has undetectable hepatitis B virus (HBV) viral load and has received HBV antiviral therapy. * If has a history of hepatitis C virus (HCV) infection, has undetectable HCV viral load. * Has a body weight ≥35 kg.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.