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)
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)
Описание
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
Кой може да участва
Age group: 18-64 years, 65+ years
Gender: Female, Male
Target enrollment: 79 participants