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

  • Cancer
  • Lung Cancer
  • Non-Small Cell Lung Cancer (NSCLC)
  • Non Small Cell Lung Carcinoma
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Active, not 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 public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Trial Summary

      This study will evaluate the efficacy, safety, and pharmacokinetics of immunotherapy-based treatment combinations in participants with metastatic non-small cell lung cancer (NSCLC). Two cohorts will be enrolled in parallel in this study: Cohort 1 will consist of participants with tumor PD-L1 expression who have received no prior systemic therapy for metastatic NSCLC, and Cohort 2 will consist of participants who experienced disease progression during or following treatment with a platinum-containing regimen and a PD-L1/PD-1 checkpoint inhibitor, given in combination as one line of therapy or as two separate lines of therapy, regardless of PD-L1 expression. In each cohort, eligible participants will initially be assigned to one of several treatment arms (Stage 1). Participants who experience disease progression, loss of clinical benefit, or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment regimen (Stage 2).

      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
      • 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 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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