A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer)

  • Non-Small Cell Lung Cancer
Trial Status:

Recruiting

This trial runs in
Countries
  • Australia
  • France
  • Israel
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom
  • United States
Trial Identifier:

NCT03337698 2017-001267-21 BO39610

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

      Results Disclaimer

      Trial 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 (1L) cohort will consist of patients who have not received any systemic therapy for their disease and the second-line (2L) cohort will consist of patients who progressed during or after receiving a platinum-containing regimen and a PD-L1/PD-1 checkpoint inhibitor treatment. In each cohort, eligible patients will be assigned to one of several treatment arms.

      Hoffmann-La Roche Sponsor
      Phase 1/Phase 2 Phase
      NCT03337698 , BO39610 , 2017-001267-21 Trial Identifier
      Atezolizumab, Cobimetinib, RO6958688, Docetaxel, CPI-444, Pemetrexed, Carboplatin, Gemcitabine, Linagliptin, Tocilizumab, Ipatasertib, Bevacizumab, Sacituzumab Govitecan, Radiation, Evolocumab Treatments
      Carcinoma, Non-Small-Cell Lung Condition
      Official 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 (Morpheus-Lung)

      Eligibility Criteria

      All Gender
      ≥ 18 Years Age
      No Healthy Volunteers
      Inclusion Criteria

      General Inclusion Criteria

      • 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
      • Availability of peripheral blood for next-generation sequencing (NGS) circulating tumor deoxyribonucleic acid (ctDNA) testing.
      • 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) >= 50%

      Inclusion Criteria for Cohort 2

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

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