Trial purpose
Cancer treatment
Tumor type
Lung cancer
Age
18+
Trial acronym
KANDLELIT-013
Clinical summary
Summary
This trial is for people with non-small cell lung cancer (NSCLC) that has a KRAS G12C mutation. The cancer must have been removed with surgery and be stages IIA to IIIB.
All participants should already have had treatment, such as chemotherapy and/or immunotherapy, either before or after surgery.
The study is testing whether adding a targeted medicine caled calderasib to standard immunotherapy (pembrolizumab) helps stop the cancer from coming back.
Participants will be randomly assigned (by chance) to receive either:
- calderasib plus pembrolizumab, or
- a placebo plus pembrolizumab
Pembrolizumab is given as an injection under the skin using a combined formulation called MK‑3475A.
Neither the participants nor the doctors will know which treatment is given during the study.
The main goal of the trial is to see if adding calderasib can lengthen the time people live without the cancer returning.
Conditions
This trial is treating people with non-small cell lung cancer that has been completely resected
Eligibility
Exclusion
- 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 active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, chronic diarrhea)
- 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
- Has not adequately recovered from major surgery or has ongoing surgical complications
Inclusion
- Your cancer has not spread to other parts of the body (localised).
- You are currently receiving treatment for your cancer.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:
- NCT07431827 *
- 2024-517337-41-00 *
- 1084-013; U1111-1312-0627; MK1084-013
Trial sponsor
Merck Sharp & Dohme LLC
Scientific Title
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)
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