A Study to Evaluate Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients with Metastatic Non-Small Cell Lung Cancer (Morpheus-Lung)
- Conditions
- Metastatic non-small cell lung cancer (NSCLC)MedDRA version: 21.1Level: PTClassification code: 10059515Term: Non-small cell lung cancer metastatic Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-504038-23-00
- Lead Sponsor
- F. Hoffmann-La Roche AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 314
Histologically or cytologically confirmed metastatic, non-squamous or squamous NSCLC, Availability of a representative tumor specimen that is suitable for determination of PD-L1 and/or additional biomarker status by means of central testing, Stage 1 and 2 Measurable disease according to Response Evaluation Criteria in Solid Tumors, Version 1.1, Stage 1 and 2 Negative HIV test at screening, Stage 1 and 2 Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative hepatitis B virus DNA test at screening, Stage 1 and 2 Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening
Activating mutation in the epidermal growth factor receptor (EGFR) gene or anaplastic lymphoma kinase (ALK) gene rearrangement, Prior allogeneic stem cell or solid organ transplantation, Treatment with systemic immunostimulatory agents within 4 weeks (or 5 half-lives of the drug, whichever is longer) or systemic immunosuppressive medication within 2 weeks prior to study treatment start, History of malignancy other than NSCLC within 2 years prior to screening with the exception of malignancies with a negligible risk of metastasis or death, Active tuberculosis, Severe infection within 4 weeks prior to initiation of study treatment
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method