2023-504038-23-00CompletedPhase 1/2
A Study to Evaluate Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients with Metastatic Non-Small Cell Lung Cancer (Morpheus-Lung)
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)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 14 Feb 2025
Brief summary (registry, in English)
Stage 1 To evaluate the efficacy of immunotherapy-based treatment combinations based on objective response (ORR)
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 149 (actual)
- First submitted
- 3 Jun 2024
- Start date
- 10 May 2018
- Lead sponsor
- F. Hoffmann-La Roche AG
- Diseases
- Lung cancer
- EU CT number
- 2023-504038-23-00
- EudraCT number
- 2017-001267-21
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 149
- 13 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Lab values
- Activating mutation in the epidermal growth factor receptor (EGFR) gene or anaplastic lymphoma kinase (ALK) gene rearrangement
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitari Vall d'Hebron | Barcelona | Spain | Completed |
| Hospital Universitario La Paz | Madrid | Spain | Completed |
| Hospital Universitario HM Sanchinarro | Madrid | Spain | Completed |
| Hospital Universitario Fundación Jiménez Díaz | Madrid | Spain | Completed |
| Hospital Universitario Regional de Málaga | Málaga | Spain | Completed |
| Clínica Universidad de navarra | Pamplona | Spain | Completed |
| Hospital Clinico Universitario de Valencia | Valencia | Spain | Completed |
| Centre hospitalier Universitaire de Bordeaux | Bordeaux | France | Completed |
| Centr Georges Francois Leclerc | Dijon | France | Completed |
| Centre Hospitalier Regional De Marseille | Marseille | France | Completed |
| Institut Regional Du Cancer De Montpellier | Montpellier Cedex 5 | France | Completed |
| Institut De Cancerologie De L Ouest | Saint-Herblain Cedex | France | Completed |
| Institut Universitaire Du Cancer Toulouse-Oncopole | Toulouse Cedex 9 | France | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.