A study of lurbinectedin in combination with atezolizumab compared with atezolizumab as maintenance therapy in participants with extensive-stage small-cell lung cancer (ES-SCLC) following first-line induction therapy with carboplatin, etoposide and atezolizumab
- Conditions
- Small-Cell Lung Cancer (SCLC)MedDRA version: 21.1Level: PTClassification code: 10041068Term: Small cell lung cancer extensive stage Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-503868-16-00
- Lead Sponsor
- F. Hoffmann-La Roche AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 658
Histologically or cytologically confirmed ES-SCLC (per the VALG staging system), Adequate hematologic and end-organ function, ECOG PS 0 or 1, No prior systemic treatment for ES-SCLC, Ongoing response or stable disease per RECIST v1.1 after completion of the induction therapy, Toxicities attributed to prior induction anti-cancer therapy or PCI resolved to Grade 1 or better
Presence or history of CNS metastases, Planned consolidative chest radiation, Uncontrolled pleural effusion, pericardial effusion or ascites requiring recurrent drainage procedures, 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, Disease progression following induction treatment
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method