Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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.
  • Drug: Atezolizumab
    Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on Day 1 of each 21-day cycle for 4 cycles in the induction phase. Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on Day 1 of each 21-day cycle in the maintenance phase.
    Other names:
    • Tecentriq, RO5541267
  • Drug: Lurbinectedin
    Lurbinectedin 3.2 mg/m² will be administered intravenously on Day 1 of each 21-day cycle in the maintenance phase.
    Other names:
    • PM01183/JZP712
  • Drug: Carboplatin
    Carboplatin will be administered according to the standard of care treatment for 4 cycles in the induction phase.
  • Drug: Etoposide
    Etoposide will be administered according to the standard of care treatment for 4 cycles in the induction phase.
Active Comparator
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.
  • Drug: Atezolizumab
    Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on Day 1 of each 21-day cycle for 4 cycles in the induction phase. Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on Day 1 of each 21-day cycle in the maintenance phase.
    Other names:
    • Tecentriq, RO5541267
  • Drug: Carboplatin
    Carboplatin will be administered according to the standard of care treatment for 4 cycles in the induction phase.
  • Drug: Etoposide
    Etoposide will be administered according to the standard of care treatment for 4 cycles in the induction phase.

More Details

Status
Active, not recruiting
Sponsor
Hoffmann-La Roche

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.