RecruitingPhase 3NCT07554339
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedCalderasib and Durvalumab

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · KRAS · Locally advanced

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 26, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 3

Interventional

Where is it offered?103 U.S. locations

Locations may change over time.

Who runs it?Merck Sharp & Dohme LLC

Study sponsor

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

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.
Reasons someone may not be able to joinExclusion criteria

The main

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

  • Low Country Cancer Care ( Site 0155)Savannah, Georgia
  • Duly Healthcare ( Site 0158)Lisle, Illinois
  • NHO Revive Research Institute LLC ( Site 0118)Lincoln, Nebraska
  • New York Oncology Hematology P.C ( Site 9000)Albany, New York
  • WakeMed Raleigh Campus ( Site 0144)Raleigh, North Carolina
  • Virginia Cancer Specialists ( Site 0114)Fairfax, Virginia
  • Instituto Alexander Fleming ( Site 0301)Ciudad Autonoma de Buenos Aires., Buenos Aires
  • Hospital Italiano de Buenos Aires. ( Site 0300)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

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 26, 2026. Always confirm current availability with the study team.

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