Integration of Immunotherapy Into Adjuvant Therapy for Resected NSCLC: ALCHEMIST Chemo-IO
Categories (click each to see list of all clinical trials associated with that category): Thoracic (ONC)
Current Status: Open
Phase: III (Cancer Control)
Principal Investigator: Ganti, Apar
Contact Information:
Jamie Willms
+1 402-559-8649
jamie.willms@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT04267848?term=NCT04267848&rank=1
Summary
PRIMARY OBJECTIVES:
I. To compare the disease free survival (DFS) and overall survival (OS) (dual primary endpoints) between combination MK-3475 (pembrolizumab) plus standard of care (Arm C) versus (vs.) standard of care (Arm A) in patients with stage IB-IIIA non-small cell lung cancer.
II. To compare the DFS and OS (dual primary endpoints) between sequential MK-3475 (pembrolizumab) following standard of care (Arm B) vs. standard of care (Arm A) followed by observation in patients with stage IB-IIIA non-small cell lung cancer.
SECONDARY OBJECTIVES:
I. To compare the DFS and OS between combination MK-3475 (pembrolizumab) with standard of care (Arm C) vs. sequential standard of care followed by MK-3475 (pembrolizumab) (Arm B) in patients with stage IB-IIIA non-small cell lung cancer.
II. To compare the adverse event rates and drug discontinuation rates due to adverse events with the addition of MK-3475 (pembrolizumab) plus standard of care (combination and/or sequential; Arms B and C) vs. standard of care alone (Arm A) as well as Arm B versus Arm C in patients with stage IB-IIIA non-small cell lung cancer.
III. To compare the DFS and OS between MK-3475 (pembrolizumab) plus standard of care (combination and/or sequential; Arms B and C) vs. standard of care alone (Arm A) by PD-L1 expression status (>= 50% vs < 50%) in patients with stage IB-IIIA non-small cell lung cancer.
IV. To compare the DFS and OS between MK-3475 (pembrolizumab) plus standard of care (combination and/or sequential; Arms B and C) vs. standard of care alone (Arm A) in patients with stage IB-IIIA non-small cell lung cancer that receive at least 2 cycles of initial adjuvant chemotherapy.
QUALITY OF LIFE OBJECTIVES:
I. To compare patient-reported quality of life (QOL) one year after randomization as assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-Core (C)30 between patients randomized to receive adjuvant chemotherapy followed by MK-3475 (pembrolizumab) (Arm B), and those randomized to receive adjuvant chemotherapy + observation (Arm A).
II. To compare patient reported QOL one year after randomization as assessed by EORTC QLQ-C30 between patients randomized to receive adjuvant chemotherapy + MK-3475 (pembrolizumab) concomitantly (Arm C) and those randomized to receive adjuvant chemotherapy + observation (Arm A).
III. To compare patient-reported QOL at completion of chemotherapy as assessed by the EORTC QLQ-C30 between patients randomized to receive adjuvant chemotherapy + MK-3475 (pembrolizumab) concomitantly (Arm C) and those randomized to receive adjuvant chemotherapy + observation or adjuvant chemotherapy followed by MK-3475 (pembrolizumab) (Arms A and B combined).
IV. To present longitudinal trajectories by arm of patient-reported dyspnea and coughing as assessed by the EORTC QLQ-Lung Cancer (LC13).
CORRELATIVE SCIENCE OBJECTIVES:
I. To compare the DFS and OS with the addition of MK-3475 (pembrolizumab) (combination and/or sequential) to standard of care platinum-based adjuvant therapy (Arms B and C) vs standard of care (Arm A) in the PD-L1 subgroup of patients with PD-L1 expression status (>= 1% vs < 1%).
II. To compare the DFS and OS with the addition of MK-3475 (pembrolizumab) (combination and/or sequential) to standard of care platinum-based adjuvant therapy (Arms B and C) vs. standard of care (Arm A) by tumor mutational burden status (high vs. low) in patients with stage IB-IIIA non-small cell lung cancer.
III. To identify a cell-free deoxyribonucleic acid (cfDNA) marker associated with high-risk of recurrence and improved DFS and OS with the addition of MK-3475 (pembrolizumab) to standard adjuvant chemotherapy (Arms B and C).