A clinical trial to compare atezolizumab plus lurbinectedin with atezolizumab alone after initial treatment with carboplatin, etoposide and atezolizumab in people with extensive-stage small-cell lung cancer (ES-SCLC)

A Phase III, Open-Label Study of Maintenance Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab in Participants With Extensive-Stage Small-Cell Lung Cancer

  • Krebs
  • Lungenkrebs
  • Kleinzelliger Lungenkrebs
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Status der Studie:

Aktiv, keine Rekrutierung

Diese Studie läuft in
Städte
  • Bad Berka
  • Berlin
  • Chemnitz
  • Essen
  • Gauting
  • Georgsmarienhütte
  • Großhansdorf
  • Halle (Saale)
  • Hannover
  • Immenhausen
  • Lübeck
  • Regensburg
Studien-ID:

NCT05091567 2023-503868-16-00 GO43104

      Studienzentren finden

      Die folgenden Informationen stammen aus der öffentlich zugänglichen Website ClinicalTrials.gov und werden für Laien bearbeitet.

      Die folgenden Informationen stammen aus der öffentlich zugänglichen Website ClinicalTrials.gov und werden nicht geändert.

      Results Disclaimer

      Studienzusammenfassung

      Study GO43104 is a Phase III, randomized, open-label, multicenter study of lurbinectedin in combination with atezolizumab compared with atezolizumab alone administered as maintenance therapy in participants with extensive-stage small-cell lung cancer (ES-SCLC) after first-line induction therapy with carboplatin, etoposide, and atezolizumab. The study consists of 2 phases: an induction phase and a maintenance phase. Participants need to have an ongoing response or stable disease per the Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 criteria after completion of 4 cycles of carboplatin, etoposide, and atezolizumab induction treatment in order to be considered for eligibility screening for the maintenance phase. Eligible participants will be randomized in a 1:1 ratio to receive either lurbinectedin plus atezolizumab or atezolizumab in the maintenance phase.

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT05091567, GO43104, 2023-503868-16-00 Studien-ID
      Atezolizumab, Lurbinectedin, Carboplatin, Etoposide Treatments
      Small-Cell Lung Cancer Condition
      Official Title

      A Phase III, Randomized, Open-Label, Multicenter Study of Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab as Maintenance Therapy in Participants With Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following First-Line Induction Therapy With Carboplatin, Etoposide and Atezolizumab

      Einschlusskriterien

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      Inclusion Criteria

      Inclusion Criteria for the Induction Phase:

      • ECOG PS of 0 or 1
      • No prior systemic therapy for ES-SCLC
      • Treatment-free for at least 6 months since last chemo/radiotherapy, among those treated (with curative intent) with prior chemo/radiotherapy for limited-stage SCLC
      • Histologically or cytologically confirmed ES-SCLC
      • Adequate hematologic and end-organ function to receive 4 cycles of induction treatment with carboplatin, etoposide and atezolizumab
      • Measurable disease, as defined by RECIST v1.1
      • Negative HIV test and no evidence of active Hepatitis B or Hepatitis C at screening

      Inclusion Criteria for the Maintenance Phase:

      • ECOG PS of 0 or 1
      • Ongoing response or stable disease per RECIST 1.1 after 4 cycles of induction therapy
      • Toxicities attributed to prior induction anti-cancer therapy or PCI resolved to Grade <=1
      • Adequate hematologic and end-organ function
      Exclusion Criteria

      Exclusion Criteria for the Induction Phase:

      • Presence or history of CNS metastases
      • Active or history of autoimmune disease or deficiency
      • History of malignancies other than SCLC within 5 years prior to enrollment
      • Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies, or lurbinectedin or trabectedin
      • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
      • Treatment with investigational therapy within 28 days prior to enrollment

        • Exclusion Criteria for the Maintenance Phase:

        • Presence or history of CNS metastases
        • Receiving consolidative chest radiation
        • Severe infection within 2 weeks prior to randomization into the maintenance
        • Treatment with therapeutic oral or IV antibiotics at the time of randomization

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