Phase III Study of Maintenance Treatment with Lurbinectedin and Atezolizumab vs. Atezolizumab Alone for Extensive-Stage Small-Cell Lung Cancer

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