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
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.
- Small-Cell Lung Cancer
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
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
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
- Phase 3
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- None (Open Label)
Arm A: Atezolizumab+Lurbinectedin
|Induction phase: participants will receive standard of care atezolizumab on Day 1 of each 21-day cycle in combination with carboplatin on Day 1 and etoposide on Days 1, 2, and 3 of each 21-day cycle for 4 cycles. Maintenance phase: participants will receive atezolizumab on Day 1 of each 21-day cycle in combination with lurbinectedin on Day 1 of each 21-day cycle.
Arm B: Atezolizumab
|Induction phase: participants will receive standard of care atezolizumab on Day 1 of each 21-day cycle in combination with carboplatin on Day 1 and etoposide on Days 1, 2, and 3 of each 21-day cycle for 4 cycles. Maintenance phase: participants will receive atezolizumab on Day 1 of each 21-day cycle.
- Active, not recruiting
- Hoffmann-La Roche