Calderasib with durvalumab for KRAS G12C-mutant lung cancer after chemotherapy and radiation
Tests calderasib plus durvalumab in adults with KRAS G12C-mutant non-small cell lung cancer.
Plain-language title generated from the registry record
Registry title: A Clinical Trial of Calderasib (MK-1084) and Durvalumab in People With Non-Small Cell Lung Cancer (MK-1084-015/KANDLELIT-015)
Key facts
- Where
- Alexandroupoli, Athens, Maroussi, and Pireas, GreeceSee the 5 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with locally advanced non-small cell lung cancer (Stage II to III) that cannot be removed by surgery and has a KRAS G12C mutation. They must have finished platinum-based chemotherapy with radiation without the cancer getting worse.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Locally advanced, unresected Stage II (node-positive) to III non-small cell lung cancer, mostly nonsquamous type.
- Earlier treatment
- Must have finished definitive platinum-based chemotherapy with radiation together, without the disease getting worse. No other earlier treatment for this lung cancer.
- Biomarker or test result
- Tumor sample must show the KRAS G12C mutation and have a PD-L1 result that can be read. Body weight must be at least 35 kg (77 lb).
Main reasons for not taking part
- Small cell lung cancer or mixed tumors with small cell parts
- Trouble swallowing pills or a gut problem that affects absorption
- Active autoimmune disease treated in the past 2 years
- Past or current pneumonitis or interstitial lung disease needing steroids
- Past stem cell or solid organ transplant
Read by machine on 11 November 2026.
Where in Greece
- University General Hospital of AlexandroupoliAlexandroupoli, GreeceTaking people
- General Hospital of Athens - AlexandraAthens, GreeceTaking people
- Thoracic General Hospital of Athens "I Sotiria"Athens, GreeceTaking people
- Athens Medical Center S.A.Maroussi, GreeceTaking people
- Metaxa Cancer Center Hospital Of PiraeusPireas, GreeceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Merck Sharp & Dohme LLC
- Trial code
- NCT07554339EU 2025-522038-29-00
- Record updated
- 10 November 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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.
Exclusion: Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease; Has received prior treatment (other than definitive CCRT) for NSCLC; Has not adequately recovered from major surgery or has ongoing surgical complications; 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 uncontrolled, significant cardiovascular disease or cerebrovascular disease; Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease; Has a known additional malignancy that is progressing or has required active treatment within the past 3 years; Has an active autoimmune disease that has required systemic treatment in the past 2 years; Has a history of, or has current, (noninfectious) pneumonitis/interstitial lung disease that required/requires steroids; Has an active infection requiring systemic therapy; Has a history of stem cell/solid organ transplant; The main exclusion criteria include but are not limited to the following:.