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Closed (no longer recruiting)Last updated: 30 January 2024

Morpheus Lung: This phase I/II trial is evaluating combinations of different immunotherapy-based treatments in patients with metastatic non-small cell (NSC) lung cancerA 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

Clinical summary

Summary

This study will evaluate the efficacy, safety, and pharmacokinetics of immunotherapy-based treatment combinations in patients with metastatic non-small cell lung cancer (NSCLC). Two cohorts will be enrolled in parallel in this study: the first-line cohort will consist of patients who have not received any systemic therapy for their disease and the second-line cohort will consist of patients who progressed after receiving a platinum-containing chemotherapy regimen and a checkpoint-inhibitor treatment. In each cohort, eligible patients will be assigned to one of several treatment arms.

Conditions

This trial is treating patients with Non-Small Cell (NSC) Lung Cancer.

Cancer

Lung Cancers Lung cancer

Age

People18+

Phase

I/II

Trial Acronym

Morpheus Lung

More information

Trial Identifiers

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Trial sponsor

Hoffmann-La Roche

Scientific Title

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

Eligibility

Inclusion

  • Eastern Cooperative Oncology Group (ECOG) performance Status of 0 or 1
  • Life expectancy greater than or equal to 3 months
  • Histologically or cytologically confirmed metastatic, non-squamous or squamous Non-Small Cell Lung Cancer (NSCLC)
  • Measurable disease (at least one target lesion)
  • Adequate hematologic and end-organ function
  • Tumor accessible for biopsy
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating eggs as outlined for each specific treatment arm
  • For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as outlined for each specific treatment arm

Inclusion Criteria for Cohort 1

  • No prior systemic therapy for metastatic NSCLC
  • High tumor PD-L1 expression, defined as Tumor Proportion Score (TPS) or TCs >= 50% or TC3

Inclusion Criteria for Cohort 2

- Disease progression during or following treatment for metastatic or locally advanced, inoperable NSCLC

Exclusion

  • Prior allogeneic stem cell or solid organ transplantation
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
  • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
  • History of leptomeningeal disease
  • Active or history of autoimmune disease or immune deficiency
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan
  • History of malignancy other than NSCLC within 2 years prior to screening
  • Active tuberculosis
  • Severe infection within 4 weeks prior to initiation of study treatment

Inclusion

  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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