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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

Next steps

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

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (13)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Hospital Universitari Vall d'HebronBarcelonaSpainCompleted
Hospital Universitario La PazMadridSpainCompleted
Hospital Universitario HM SanchinarroMadridSpainCompleted
Hospital Universitario Fundación Jiménez DíazMadridSpainCompleted
Hospital Universitario Regional de MálagaMálagaSpainCompleted
Clínica Universidad de navarraPamplonaSpainCompleted
Hospital Clinico Universitario de ValenciaValenciaSpainCompleted
Centre hospitalier Universitaire de BordeauxBordeauxFranceCompleted
Centr Georges Francois LeclercDijonFranceCompleted
Centre Hospitalier Regional De MarseilleMarseilleFranceCompleted
Institut Regional Du Cancer De MontpellierMontpellier Cedex 5FranceCompleted
Institut De Cancerologie De L OuestSaint-Herblain CedexFranceCompleted
Institut Universitaire Du Cancer Toulouse-OncopoleToulouse Cedex 9FranceCompleted

Are you the coordinator? Confirm the details

This page is information, not medical advice. Discuss any trial with your doctor.