M7824 With cCRT in Unresectable Stage III Non-small Cell Lung Cancer (NSCLC)

Authors
Category Primary study
Registry of TrialsJapan Registry of Clinical Trials (JRCT)
Year 2019
INTERVENTION: Intervention name : M7824 INN of the intervention : Bintrafusp alfa Dosage And administration of the intervention : Participants will receive intravenous infusion of 1200 milligram (mg) M7824 over 1 hour every 2 weeks (q2w) during cCRT and up to 1 year after cCRT until unacceptable toxicity, confirmed disease progression assessed by investigator. Intervention name : Etoposide INN of the intervention : Etoposide Dosage And administration of the intervention : Participants will receive etoposide 50 mg/m^2 intravenously over a minimum of 30 minutes up to 60 minutes daily on Day 1 to 5 and Day 29 to 33 during cCRT. Intervention name : Pemetrexed INN of the intervention : Pemetrexed Dosage And administration of the intervention : Participants will receive pemetrexed at a dose of 500 mg/m^2 intravenously over 10 minutes or according to local standards on Days 1, 22, and 43 during cCRT. Intervention name : Carboplatin INN of the intervention : Carboplatin Dosage And administration of the intervention : Participants will receive carboplatin intravenously based on area under curve (AUC) 2 over 30 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 during cCRT. Intervention name : Paclitaxel INN of the intervention : Paclitaxel Dosage And administration of the intervention : Participants will receive paclitaxel intravenously at a dose of 45 mg/m^2 over 60 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 during cCRT. Intervention name : Cisplatin INN of the intervention : Cisplatin Dosage And administration of the intervention : In combination with etoposide, participants will receive cisplatin 50 mg/m^2 intravenously over 60 minutes on Days 1, 8, 29, and 36 during cCRT. In combination with pemetrexed, participants will receive cisplatin 75 mg/m2 intravenously over 60 minutes on Days 1, 22, and 43 during cCRT. Control intervention name : Placebo INN of the control intervention : ‐ Dosage And administration of the control intervention : Pa CONDITION: Non‐small Cell Lung Cancer PRIMARY OUTCOME: efficacy; Progression‐free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) Assessed by Independent Review Committee (IRC) [ Time Frame: Time from first dose up to 59 Months ] SECONDARY OUTCOME: safety, efficacy, pharmacokinetics, pharmacodynamics; 1.Occurrence of Treatment Emergent Adverse Events (TEAEs) and Treatment‐related AEs [ Time Frame: Baseline up to 8.8 years ]; 2.Overall Survival [ Time Frame: Baseline up to 8.8 years ]; 3.Changes from Baseline in Diffusing Capacity of Lung for Carbon Monoxide (DLCO) [ Time Frame: Baseline up to 14 months ]; 4.Programmed death‐ligand 1 (PD‐L1) Expression in Tumors Assessed with Immunohistochemistry (IHC) and Association with Efficacy [ Time Frame: Baseline up to 8.8 years ]; 5.Objective Response According to RECIST 1.1 Assessed by IRC [ Time Frame: Baseline up to 8.8 years ]; 6.Duration of Response According to RECIST 1.1 [ Time Frame: Baseline up to 8.8 years ]; 7.Immunogenicity of M7824 as Measured by Antidrug Antibody (ADA) Assays [ Time Frame: Baseline up to 8.8 years ]; 8.Concentration Immediately Before Next Dosing (Ctrough) [ Time Frame: Baseline up to 14 months ]; 9.Concentration Immediately at End of Infusion (Ceoi) [ Time Frame: Baseline up to 14 months ]; 10.Changes from Baseline in High‐resolution Computed Tomography (HRCT) [ Time Frame: Baseline up to 14 months ]; 11.Changes from Baseline in Forced Expiratory Volume in one Second (FEV1) [ Time Frame: Baseline up to 14 months ]; 12.Changes from Baseline in Forced Vital Capacity (FVC) [ Time Frame: Baseline up to 14 months ]; 13.Changes from Baseline in 6‐minutes Walking Test [ Time Frame: Baseline up to 14 months ] INCLUSION CRITERIA: ‐Participants must have histologically documented NSCLC who present with Stage III locally advanced, unresectable disease (International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology ‐Participants with tumor harboring an Epidermal growth factor receptor (EGFR) sensitizing (activating) mutation, Anaplastic lymphoma kinase (ALK) translocation, ROS‐1 rearrangement are eligible. ‐Participants must have adequate pulmonary function defined as a forced expiratory volume in 1 second (FEV1) greater than equals to (>=) 1.2 liters or 50 percent or more of predicted normal volume measured within 3 weeks prior to randomization. ‐Adequate hematological, hepatic and renal function as defined in the protocol ‐Contraceptive use by males or females will be consistent with local regulations on contraception methods for those participating in clinical studies
Epistemonikos ID: 616f7c7773f8a573cb5dca90ea69f8e7bdfcf5bb
First added on: Aug 24, 2024