RecruitingNCT07554339ClinicalTrials.gov record

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

Non-small Cell Lung Cancer

Ask WCR about this study Official registry record ↗

THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type: Interventional
Phase: Phase 3
Age range: 18 years - Not specified
Sex eligible: All sexes
Healthy volunteers: Not accepted
Participants: 310 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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.

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Random assignment
Masking: Triple masked

Calderasib + Durvalumab

Participants will receive calderasib and durvalumab.

Drug: Calderasib · Biological: Durvalumab

Placebo + Durvalumab

Participants will receive placebo to calderasib and durvalumab.

Biological: Durvalumab · Other: Placebo to MK-1084

Calderasib DRUG

Tablet for oral administration.

Durvalumab BIOLOGICAL

Solution for intravenous (IV) infusion.

Placebo to MK-1084 OTHER

Placebo to MK-1084.

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Progression-Free Survival (PFS)

Time frame: 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.