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

• Status: Not yet recruiting
• Trial end date: 2025-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Collaborator: Jazz Pharmaceuticals
• Treatments: Atezolizumab; Carboplatin; Etoposide

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

Exclusion Criteria for the Induction Phase:

• 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:

• 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