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Calderasib and Durvalumab for KRAS G12C Non-Small Cell Lung Cancer

Researchers are studying a new way to treat locally advanced non-small cell lung cancer (NSCLC) that has a specific gene change called KRAS G12C. This study is testing if a drug called calderasib, given as a tablet, can be used with durvalumab, an immunotherapy given through an IV, after you've had chemotherapy and radiation. The goal is to see if this combination helps people live longer without their cancer growing or spreading, compared to receiving a placebo (an inactive substance) and durvalumab. You may be able to join if you have unresected Stage II or III NSCLC with a KRAS G12C mutation.

Study design
This interventional study plans to enroll 310 participants. It compares a group receiving calderasib and durvalumab to a group receiving a placebo and durvalumab.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to approximately 6 years to measure how long they live without their cancer growing or spreading.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07554339

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Merck Sharp & Dohme LLC
~310 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:CalderasibDurvalumabPlacebo to MK-1084

At a glance

Recruiting sites
59 of 59 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-Free Survival (PFS)
Measured over Up to approximately 6 years

Conditions

Non-small Cell Lung Cancer

Explore related trials

Lung Non-Small Cell CarcinomaGTPase KRasProgrammed Cell Death 1 Ligand 1

Where it's being run

59 sites across 43 states
Spain4
Taiwan4
Buenos Aires3
Attica3
Fujian2
Hubei2
Kyonggi-do2
South Korea2

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

Toll Free Number
[email protected]
1-888-577-8839
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Progression-Free Survival (PFS)Up to approximately 6 years

    PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first.