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Sponsor: Hoffmann-La Roche
Conditions: Small-Cell Lung Cancer
Interventions: Atezolizumab, Lurbinectedin, Carboplatin, Etoposide
Countries: United States, Belgium, Germany, Greece, Hungary, Italy, Mexico, Poland
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.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
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 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 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 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
- Marietta, Georgia, United States
- Peoria, Illinois, United States
- Scarborough, Maine, United States
- Boston, Massachusetts, United States
- Grand Rapids, Michigan, United States
- St Louis, Missouri, United States
- Westbury, New York, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Providence, Rhode Island, United States
- Charleston, South Carolina, United States
- Chattanooga, Tennessee, United States
- Germantown, Tennessee, United States
- Nashville, Tennessee, United States
- Anderlecht, Belgium
- Hasselt, Belgium
- Leuven, Belgium
- Mechelen, Belgium
- Mont-godinne, Belgium
- Sint-Niklaas, Belgium
- Bad Berka, Germany
- Berlin, Germany
- Berlin, Germany
- Chemnitz, Germany
- Essen, Germany
- Georgsmarienhütte, Germany
- Großhansdorf, Germany
- Halle, Germany
- Immenhausen, Germany
- Lübeck, Germany
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