Calderasib added to pembrolizumab after surgery for KRAS G12C lung cancer
Tests calderasib plus pembrolizumab after surgery in adults with KRAS G12C non-small cell lung cancer.
Plain-language title generated from the registry record
Registry title: MK-3475A±Calderasib (MK-1084) in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013)
Key facts
- Where
- Athens, Maroussi, Pireas, and Thessaloniki, GreeceSee the 6 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 non-small cell lung cancer (mainly nonsquamous) with a KRAS G12C mutation, whose stage IIA-IIIB (N2) tumor has been completely removed by surgery.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Completely resected stage IIA-IIIB (N2) non-small cell lung cancer, mainly nonsquamous, with no sign of disease on scans after surgery
- Earlier treatment
- People must have had surgery after pembrolizumab or MK-3475A plus platinum chemotherapy, or have had platinum chemotherapy after surgery. No more than 12 weeks may pass between surgery or the last chemotherapy dose and the first study dose.
- Biomarker or test result
- The tumor tissue must show a KRAS G12C mutation
Main reasons for not taking part
- Small cell lung cancer, mixed tumors with small cell parts, large cell neuroendocrine tumor, sarcomatoid carcinoma, or a tumor in the superior sulcus
- Active inflammatory bowel disease, or a clear past history of it
- Uncontrolled serious heart or brain blood vessel disease in the past 6 months
- Current or past pneumonitis or interstitial lung disease that needed steroids
- Another cancer that is getting worse or needed treatment in the past 3 years
Read by machine on 11 November 2026.
Where in Greece
- Evangelismos S AAthens, GreeceTaking people
- Henry Dunant Hospital CenterAthens, 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
- Geniko Nosokomeio Thessalonikis George PapanikolaouThessaloniki, 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
- NCT07431827EU 2024-517337-41-00
- Record updated
- 10 November 2026
- Original description
This is a phase 3, randomized, double-blind study of adjuvant calderasib plus subcutaneous pembrolizumab and berahyaluronidase alfa (MK-3475A) versus adjuvant placebo plus MK-3475a in participants with completely resected stage IIA-IIIB (N2), KRAS G12C-mutant non-small cell lung cancer following receipt of either neoadjuvant pembrolizumab plus chemotherapy or adjuvant chemotherapy. The primary goal of the study is to compare adjuvant calderasib plus MK-3475A to adjuvant placebo plus MK-3475A with respect to disease-free survival (DFS) as assessed by the investigator.Read full original descriptionShow less
A Phase 3, Randomized, Double-blind Study of Adjuvant MK-1084 Plus Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) Versus Adjuvant Placebo Plus MK-3475A in Participants With Completely Resected Stage IIA-IIIB (N2), KRAS G12C-mutant Non-small Cell Lung Cancer Following Receipt of Either Neoadjuvant Pembrolizumab Plus Chemotherapy or Adjuvant Chemotherapy (KANDLELIT-013)
This is a phase 3, randomized, double-blind study of adjuvant calderasib plus subcutaneous pembrolizumab and berahyaluronidase alfa (MK-3475A) versus adjuvant placebo plus MK-3475a in participants with completely resected stage IIA-IIIB (N2), KRAS G12C-mutant non-small cell lung cancer following receipt of either neoadjuvant pembrolizumab plus chemotherapy or adjuvant chemotherapy. The primary goal of the study is to compare adjuvant calderasib plus MK-3475A to adjuvant placebo plus MK-3475A with respect to disease-free survival (DFS) as assessed by the investigator.
Inclusion: Has a histological/cytological diagnosis of non-small cell lung cancer (NSCLC) with predominantly nonsquamous histology and meets one of the following criteria:; Has newly diagnosed, treatment-naïve, resectable, clinical Stage IIA-IIIB (N2) NSCLC; Has completely resected, pathological Stage IIA-IIIB (N2) NSCLC, including those previously treated outside the study with neoadjuvant platinum-doublet chemotherapy plus pembrolizumab or MK-3475A, or those who received adjuvant platinum-doublet chemotherapy; Tumor tissue shows the presence of Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation; No more than 12 weeks have elapsed between either the surgery following neoadjuvant treatment or last dose of adjuvant platinum-based chemotherapy and the first dose of investigational adjuvant study intervention; Has no evidence of disease based on postsurgical radiological assessment as documented by contrast-enhanced chest/abdomen computed tomography (or magnetic resonance imaging) within 28 days before randomization; Has an Eastern Cooperative Oncology Group performance status of 0 or 1 within 10 days before the first dose of the study intervention; Human immunodeficiency virus-infected participants must have well controlled HIV on antiretroviral therapy; Participants who are Hepatitis B surface antigen positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load; Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable.
Exclusion: Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, chronic diarrhea); Has not adequately recovered from major surgery or has ongoing surgical complications; Has a diagnosis of any 1 of the following tumor types/locations: small cell lung cancer or, for mixed tumors, presence of small cell elements, neuroendocrine tumor with large cell components, sarcomatoid carcinoma, or NSCLC involving the superior sulcus; HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease; Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within the 6 months preceding study intervention; Is unable to swallow orally administered medication, or has a gastrointestinal disorder affecting absorption (e.g. gastrectomy, partial bowel obstruction, or malabsorption); Has 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 except replacement therapy; Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease; Has active infection requiring systemic therapy.