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Recruiting Phase 3 2024-517337-41-00

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)

Phase 3 – large-scale trial before approval
Conditions: Completely resected Stage IIA-IIIB (N2) KRAS G12C mutated NSCLC

Sponsor: Merck Sharp & Dohme LLC

trial.available_in: БГ
Overview
Trial status: Authorised Overall Survival (OS), Distant Metastasis-Free Survival (DMFS), Lung Cancer Specific Survival (LCSS), 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, Change from Baseline in the EORTC-QLQ-C30 Physical Functioning (Items 1-5) Combined Score, Change from Baseline in the EORTC-QLQ-C30 Role Functioning (Items 6 and 7) Combined Score, Change from Baseline in the EORTC-QLQ-C30 Dyspnea (Item 8) Score, Change from Baseline in the EORTC-Quality of Life Questionnaire-Lung Cancer 24 (QLQ-LC24) Coughing (Items 31 and 52) Combined Score, Change from Baseline in the EORTC-QLQ-LC24 Chest Pain (Item 40) Score, Number of Participants Who Experience an Adverse Event (AE), Number of Participants Who Discontinue Study Treatment Due to an AE Disease-Free Survival (DFS)
Description
Overall Survival (OS), Distant Metastasis-Free Survival (DMFS), Lung Cancer Specific Survival (LCSS), 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, Change from Baseline in the EORTC-QLQ-C30 Physical Functioning (Items 1-5) Combined Score, Change from Baseline in the EORTC-QLQ-C30 Role Functioning (Items 6 and 7) Combined Score, Change from Baseline in the EORTC-QLQ-C30 Dyspnea (Item 8) Score, Change from Baseline in the EORTC-Quality of Life Questionnaire-Lung Cancer 24 (QLQ-LC24) Coughing (Items 31 and 52) Combined Score, Change from Baseline in the EORTC-QLQ-LC24 Chest Pain (Item 40) Score, Number of Participants Who Experience an Adverse Event (AE), Number of Participants Who Discontinue Study Treatment Due to an AE
Who can participate
Age group: 18-64 years, 65+ years Gender: Female, Male Target enrollment: 79 participants
Interventions
MK-1084
Drug
MK-3475A
Drug
CARBOPLATIN
Drug
PEMETREXED
Drug
MK-1084
Drug
CISPLATIN
Drug
Placebo for MK-1084
Drug
Locations 4
France (1)
Germany (1)
Greece (1)
Spain (1)
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
20.04.2026
Registry ID
2024-517337-41-00
Source
euclinicaltrials.eu
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