A Study to Evaluate Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients with Metastatic Non-Small Cell Lung Cancer (Morpheus-Lung)
Key facts
- Where
- Barcelona, Madrid, Málaga, Pamplona és Valencia, SpanyolországSee the 7 sites
- Phase
- 1/2. fázis
Where in Spanyolország
- Hospital Universitari Vall d'HebronBarcelona, SpanyolországNo longer taking part
- Hospital Universitario Fundación Jiménez DíazMadrid, SpanyolországNo longer taking part
- Hospital Universitario HM SanchinarroMadrid, SpanyolországNo longer taking part
- Hospital Universitario La PazMadrid, SpanyolországNo longer taking part
- Hospital Universitario Regional de MálagaMálaga, SpanyolországNo longer taking part
- Clínica Universidad de navarraPamplona, SpanyolországNo longer taking part
- Hospital Clinico Universitario de ValenciaValencia, SpanyolországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- F. Hoffmann-La Roche AG
- Trial code
- EU 2023-504038-23-00
- Record updated
- 2025. február 14.
- Original description
Stage 1 To evaluate the efficacy of immunotherapy-based treatment combinations based on objective response (ORR)Read full original descriptionShow less
A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients with Metastatic Non-Small Cell Lung Cancer (Morpheus-Lung)
Stage 1 To evaluate the efficacy of immunotherapy-based treatment combinations based on objective response (ORR)
Inclusion: 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.
Exclusion: 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; Severe infection within 4 weeks prior to initiation of study treatment; 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; Activating mutation in the epidermal growth factor receptor (EGFR) gene or anaplastic lymphoma kinase (ALK) gene rearrangement.