RecruitingPhase 3NCT07554339

A Clinical Trial of Calderasib (MK-1084) and Durvalumab in People With Non-Small Cell Lung Cancer (MK-1084-015/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.

Checked against the public recordLast updated Aug 28, 2026 · Source: ClinicalTrials.gov

StatusRecruiting
PhasePhase 3
U.S. locations63
SponsorMerck Sharp & Dohme LLC
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
Merck Sharp & Dohme LLC
Interventions being studied
Drug: Calderasib; Biological: Durvalumab; Other: Placebo to MK-1084
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • NHO Revive Research Institute LLC ( Site 0118)Lincoln, Nebraska
  • New York Oncology Hematology P.C ( Site 9000)Albany, New York
  • Instituto Alexander Fleming ( Site 0301)Ciudad Autonoma de Buenos Aires., Buenos Aires
  • Clinica Adventista Belgrano ( Site 0304)Ciudad Autonoma de Buenos Aires, Buenos Aires
  • Instituto de Investigaciones Clínicas Mar del Plata ( Site 0303)Mar del Plata, Buenos Aires
  • Hospital Britanico de Buenos Aires ( Site 0305)Buenos Aires, Buenos Aires F.D.
  • Sanatorio Parque ( Site 0302)Rosario, Santa Fe Province
  • Northern Beaches Hospital ( Site 2401)Frenchs Forest, New South Wales
  • AFECC ASSOCIACAO FEMININA EDUCACAO COMBATE CANCER ( Site 0416)Vitória, Espírito Santo
  • Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0401)Barretos, São Paulo
  • Anhui Provincial Cancer Hospital ( Site 2209)Hefei, Anhui
  • Zhongshan Hospital Affiliated to Xiamen University ( Site 2213)Xiamen, Fujian

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 28, 2026. Always confirm current availability with the study team.

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