NCT07431827
Recruiting
Phase 3
A Phase 3, Randomized, Double-blind Study of Adjuvant MK-1084 Plus Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) Versus Adjuvant Placebo Plus MK-3475A in Participants With Completely Resected Stage IIA-IIIB (N2), KRAS G12C-mutant Non-small Cell Lung Cancer Following Receipt of Either Neoadjuvant Pembrolizumab Plus Chemotherapy or Adjuvant Chemotherapy (KANDLELIT-013)
Merck Sharp & Dohme LLC17 sites in 3 countries400 target enrollmentStarted: March 18, 2026Last updated:
DrugsCalderasib
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 400
- Locations
- 17
- Primary Endpoint
- Disease-free Survival (DFS)
Overview
Brief Summary
This is a phase 3, randomized, double-blind study of adjuvant calderasib plus subcutaneous pembrolizumab and berahyaluronidase alfa (MK-3475A) versus adjuvant placebo plus MK-3475a in participants with completely resected stage IIA-IIIB (N2), KRAS G12C-mutant non-small cell lung cancer following receipt of either neoadjuvant pembrolizumab plus chemotherapy or adjuvant chemotherapy. The primary goal of the study is to compare adjuvant calderasib plus MK-3475A to adjuvant placebo plus MK-3475A with respect to disease-free survival (DFS) as assessed by the investigator.
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
- •Has a histological/cytological diagnosis of non-small cell lung cancer (NSCLC) with predominantly nonsquamous histology and meets one of the following criteria:
- •Has newly diagnosed, treatment-naïve, resectable, clinical Stage IIA-IIIB (N2) NSCLC
- •Has completely resected, pathological Stage IIA-IIIB (N2) NSCLC, including those previously treated outside the study with neoadjuvant platinum-doublet chemotherapy plus pembrolizumab or MK-3475A, or those who received adjuvant platinum-doublet chemotherapy.
- •Tumor tissue shows the presence of Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation
- •No more than 12 weeks have elapsed between either the surgery following neoadjuvant treatment or last dose of adjuvant platinum-based chemotherapy and the first dose of investigational adjuvant study intervention.
- •Has no evidence of disease based on postsurgical radiological assessment as documented by contrast-enhanced chest/abdomen computed tomography (or magnetic resonance imaging) within 28 days before randomization
- •Has an Eastern Cooperative Oncology Group performance status of 0 or 1 within 10 days before the first dose of the study intervention
- •Human immunodeficiency virus-infected participants must have well controlled HIV on antiretroviral therapy
- •Participants who are Hepatitis B surface antigen positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load
- •Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
Exclusion Criteria
- •Has a diagnosis of any 1 of the following tumor types/locations: small cell lung cancer or, for mixed tumors, presence of small cell elements, neuroendocrine tumor with large cell components, sarcomatoid carcinoma, or NSCLC involving the superior sulcus
- •HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- •Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, chronic diarrhea)
- •Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within the 6 months preceding study intervention
- •Is unable to swallow orally administered medication, or has a gastrointestinal disorder affecting absorption (e.g. gastrectomy, partial bowel obstruction, or malabsorption)
- •Has 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 except replacement therapy
- •Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- •Has active infection requiring systemic therapy
- •Has not adequately recovered from major surgery or has ongoing surgical complications
Arms & Interventions
Placebo + MK-3475A
Active Comparator
Participants receive placebo qd and MK-3475A q6w for up to 9 doses.
Intervention: Placebo (Drug)
Placebo + MK-3475A
Active Comparator
Participants receive placebo qd and MK-3475A q6w for up to 9 doses.
Intervention: MK-3475A (Biological)
Calderasib + MK-3475A
Experimental
Participants receive calderasib daily (qd) and MK-3475A every 6 weeks (q6w) for up to 9 doses.
Intervention: Calderasib (Drug)
Calderasib + MK-3475A
Experimental
Participants receive calderasib daily (qd) and MK-3475A every 6 weeks (q6w) for up to 9 doses.
Intervention: MK-3475A (Biological)
Outcomes
Primary Outcomes
Disease-free Survival (DFS)
Time Frame: Up to ~11 years
DFS is the time from randomization to any recurrence (local, locoregional, regional, or distant), occurrence of new primary NSCLC, or death due to any cause, whichever occurs first.
Secondary Outcomes
- Overall Survival (OS)(Up to ~11 years)
- Distant Metastasis-Free Survival (DMFS)(Up to ~11 years)
- Lung Cancer Specific Survival (LCSS)(Up to ~11 years)
- Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score(Up to ~11 years)
- Change from Baseline in the EORTC-QLQ-C30 Physical Functioning (Items 1-5) Combined Score(Up to ~11 years)
- Change from Baseline in the EORTC-QLQ-C30 Role Functioning (Items 6 and 7) Combined Score(Up to ~11 years)
- Change from Baseline in the EORTC-QLQ-C30 Dyspnea (Item 8) Score(Up to ~11 years)
- Change from Baseline in the EORTC-Quality of Life Questionnaire-Lung Cancer 24 (QLQ-LC24) Coughing (Items 31 and 52) Combined Score(Up to ~11 years)
- Change from Baseline in the EORTC-QLQ-LC24 Chest Pain (Item 40) Score(Up to ~11 years)
- Number of Participants Who Experience an Adverse Event (AE)(Up to ~13.5 years)
- Number of Participants Who Discontinue Study Treatment Due to an AE(Up to ~13.5 years)
Investigators
Study Sites (17)
Loading locations...
Similar Trials
Recruiting
Phase 2
Neo-adjuvant pembroliuzmab as an alternative treatment for MMRd uterine cancer2024-516736-10-00Universitair Medisch Centrum Groningen12
Active, not recruiting
Phase 2
Phase II, multi‑cohort trial of neoadjuvant and post‑surgery IO102‑IO103 and pembrolizumab in patients with selected resectable tumors2022-502787-20-00IO Biotech ApS65
Recruiting
Phase 2
Neoadjuvant Pembrolizumab in Patients With Stage IIb/c MelanomaNCT07349303Vastra Gotaland Region30
Not yet recruiting
Not Applicable
Adebrelimab Neoadjuvant Treatment for Resectable ESCCNCT07388095Tianjin Medical University Cancer Institute and Hospital22
Active, not recruiting
Phase 3
Adjuvant Therapy with Pembrolizumab versus Placebo in Resected High-risk Stage II Melanoma2022-501966-23-00Merck Sharp & Dohme LLC530