NCT07554339 A Clinical Trial of Calderasib (MK-1084) and Durvalumab in People With Non-Small Cell Lung Cancer (MK-1084-015/KANDLELIT-015)
| NCT ID | NCT07554339 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Merck Sharp & Dohme LLC |
| Condition | Non-small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 310 participants |
| Start Date | 2026-06-18 |
| Primary Completion | 2032-12-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 310 participants in total. It began in 2026-06-18 with a primary completion date of 2032-12-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: 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 Criteria: The main exclusion criteria include but are not limited to the following: * 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. * Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease. * Has received prior treatment (other than definitive CCRT) for NSCLC. * 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. * Has not adequately recovered from major surgery or has ongoing surgical complications.
Contact & Investigator
Medical Director
STUDY DIRECTOR
Merck Sharp & Dohme LLC
Frequently Asked Questions
Who can join the NCT07554339 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non-small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07554339 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 310 participants.
Is NCT07554339 currently recruiting?
Yes, NCT07554339 is actively recruiting participants. Contact the research team at Trialsites@msd.com for enrollment information.
Where is the NCT07554339 trial being conducted?
This trial is being conducted at Lincoln, United States, Suwon, South Korea, Daegu, South Korea, Seoul, South Korea and 11 additional locations.
Who is sponsoring the NCT07554339 clinical trial?
NCT07554339 is sponsored by Merck Sharp & Dohme LLC. The principal investigator is Medical Director at Merck Sharp & Dohme LLC. The trial plans to enroll 310 participants.
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