M7824 with cCRT in Unresectable Stage III NSCLC

Phase 1

• Conditions: nresectable Stage III Non-small Cell Lung Cancer; MedDRA version: 21.1Level: PTClassification code 10029519Term: Non-small cell lung cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-003265-34-DE
• Lead Sponsor: Merck KGaA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-12
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

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 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified