NCT07554339
Not yet recruiting
Phase 3
A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator-Controlled Study of MK-1084 Plus Durvalumab Versus Placebo Plus Durvalumab in Participants With Locally Advanced, Unresected KRAS G12C-Mutant Non-Small Cell Lung Cancer Without Disease Progression Following Definitive Platinum-Based Chemoradiotherapy (KANDLELIT-015)
ConditionsNon-small Cell Lung Cancer
DrugsCalderasib
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 310
- Primary Endpoint
- Progression-Free Survival (PFS)
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Placebo + Durvalumab
Active Comparator
Participants will receive placebo to calderasib and durvalumab.
Intervention: Placebo to MK-1084 (Other)
Calderasib + Durvalumab
Experimental
Participants will receive calderasib and durvalumab.
Intervention: Calderasib (Drug)
Calderasib + Durvalumab
Experimental
Participants will receive calderasib and durvalumab.
Intervention: Durvalumab (Biological)
Placebo + Durvalumab
Active Comparator
Participants will receive placebo to calderasib and durvalumab.
Intervention: Durvalumab (Biological)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Overall Survival (OS)(Up to approximately 9 years)
- Number of Participants Who Experience an Adverse Events (AEs)(Up to approximately 9 years)
- Number of Participants Who Discontinue Study Treatment Due to an AE(Up to approximately 9 years)
- Objective Response Rate (ORR)(Up to approximately 9 years)
- Duration of Response (DOR)(Up to approximately 9 years)
- Distant Metastasis-Free Survival (DMFS)(Up to approximately 9 years)
- Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS)/Quality of Life (QoL) (Items 29 & 30) Combined Score(Baseline and up to approximately 9 years)
- Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score(Baseline and up to approximately 9 years)
- Change from Baseline in Role Functioning (EORTC QLQ-C30 Items 6 & 7) Combined Score(Baseline and up to approximately 9 years)
Investigators
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