Title: A phase III, randomized, open-label, multicenter 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
Responsible Party: Hoffmann-La Roche
Description: Researchers are conducting a phase 3 study to determine if adding lurbinectedin to atezolizumab maintenance will improve outcomes in patients with extensive-stage small cell lung cancer (ES-SCLC) who have received first-line treatment with carboplatin, etoposide, and atezolizumab.
Patients will be assigned to 1 of 2 study arms. For induction, patients in both arms will receive 1200 mg of atezolizumab on day 1 of each 21-day cycle, in combination with standard carboplatin and etoposide, for 4 cycles.
For maintenance, patients in the experimental arm will receive atezolizumab (1200 mg) in combination with lurbinectedin (3.2 mg/m2 ) on day 1 of each cycle. Patients in the active control arm will receive atezolizumab (1200 mg) alone on day 1 of each cycle.
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The primary outcomes of this study are progression-free survival and overall survival. Some secondary outcomes include objective response rate, duration of response, percentage of participants with adverse events, percentage of participants with anti-drug antibodies to atezolizumab, and time to confirmed deterioration.
To be eligible for this study, patients must be 18 years of age or older and have histologically or cytologically confirmed ES-SCLC. They must not have had prior systemic therapy for ES-SCLC, or they must have been treatment-free for at least 6 months if they received chemotherapy or radiotherapy for limited-stage SCLC. For a complete list of eligibility criteria, please see the reference.
Status: Recruiting
This study is sponsored by Hoffmann-La Roche in collaboration with Jazz Pharmaceuticals.
Reference
ClinicalTrials.gov. 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 (IMforte). NCT05091567. Accessed September 5, 2023.
