Unresectable Stage III Non-small Cell Lung Cancer MedDRA version: 20.0 Level: PT Classification code 10029519 Term: Non-small cell lung cancer stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: M7824
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: bintrafusp alfa (proposed INN)
Current Sponsor code: MSB0011359C
Other descriptive name: M7824
Conce
Sponsors
Merck KGaA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Investigator 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 [IASLC Staging Manual in Thoracic Oncology], v8). 2. Participants with tumor harboring an EGFR sensitizing (activating) mutation, ALK translocation, ROS-1 rearrangement are eligible. These tests are not required for enrollment in the study. 3. Participants must have adequate pulmonary function defined as a forced expiratory volume in 1 second (FEV1) = 1.2 liters or = 50% of predicted normal volume measured within 3 weeks prior to randomization. If participants do not meet the above criteria, treatment with inhaled steroids and bronchodilators can be initiated if clinically indicated and eligibility can be reassessed after 1-2 weeks. 4. 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 5. Other protocol defined inclusion criteria could apply Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 175 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 175
Exclusion criteria
Exclusion criteria: 1. Participants with Mixed small cell with non-small cell lung cancer histology 2. Recent major surgery within 4 weeks prior to entry into the study 3. Significant acute or chronic infections 4. Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization 5. Active autoimmune disease that has required systemic treatment in past 1 year (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) Other protocol defined exclusion criteria could apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate PFS in participants treated with cCRT plus M7824 followed by M7824 or cCRT plus placebo followed by durvalumab;Secondary Objective: To evaluate the safety in participants treated with cCRT plus M7824 followed by M7824 or cCRT plus placebo followed by durvalumab To evaluate OS in participants treated with cCRT plus M7824 followed by M7824 or cCRT plus placebo followed by durvalumab To evaluate changes in lung function in participants treated with cCRT plus M7824 followed by M7824 or cCRT plus placebo followed by durvalumab To evaluate the association of PD-L1 expression at Baseline with efficacy in participants treated with cCRT plus M7824 followed by M7824 or cCRT plus placebo followed by durvalumab To evaluate objective tumor response in participants treated with cCRT plus M7824 followed by M7824 or cCRT plus placebo followed by durvalumab To evaluate duration of response in participants treated with cCRT plus M7824 followed by M7824 or cCRT plus placebo followed by durvalumab To characterize PK profile of M7824 plus cCRT and after cCRT To characterize the immunogenicity of M7824 plus cCRT and after cCRT;Primary end point(s): Progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) assessed by Independent Review Committee (IRC);Timepoint(s) of evaluation of this end point: Time from randomization to final assessment at 8 years and 10 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Occurrence of Treatment-emergent Adverse Events (TEAEs) and treatment-related Adverse Events (AEs) 2. Overall Survival 3. Changes from Baseline in pulmonary function 4. Programmed death-ligand 1 (PD-L1) expression in tumors at Baseline 5. Objective response according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) 6. Duration of response 7. Pharmacokinetics profile of M7824 in terms of Ceoi and Ctrough 8. Immunogenicity of M7824 ;Timepoint(s) of evaluation of this end point: 1. Time from randomization to final assessment at 8 years and 10 months 2. Time from randomization to final assessment at 8 years and 10 months 3. Time from randomization to final assessment at 14 months 4. Randomization 5. Time from randomization to final assessment at 8 years and 10 months 6. Time from randomization to final assessment at 8 years and 10 months 7. Time from randomization to final assessment at 17 months 8. Time from randomization to final assessment at 17 months | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, China, European Union, France, Germany, Hungary, Japan, Korea, Republic of, Netherlands, Norway, Russian Federation, Spain, Taiwan, Turkey, United States
Contacts
Public ContactCommunication Center Merck KGaA
Merck KGaA
Outcome results
None listed