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

Phase 2

Completed

• Conditions: on-small Cell Lung Cancer

• Registration Number: JPRN-jRCT2080224688
• Lead Sponsor: Merck Biopharma Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-17
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 350

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

Exclusion Criteria

-Participants with Mixed small cell with non-small cell lung cancer histology
-Recent major surgery within 4 weeks prior to entry into the study
-Significant acute or chronic infections including human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome, Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection and active tuberculosis
-Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization
-Active autoimmune disease that has required systemic treatment in past 1 year (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs)
-Any prior systemic cytotoxic chemotherapy for their NSCLC or any antibody or drug targeting T-cell coregulatory proteins

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
efficacy<br>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 ]