Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05091567 | 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 | PHASE3 | ACTIVE NOT_RECRUITING | 660 | — | — | Nov 18, 2021 | Aug 13, 2026 | Mar 10, 2026 | 96 | United States, Belgium +11 |
PFS was defined as the time from randomization to the date of first documented PD as determined by the IRF according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or death, whichever occurs first. PD was defined as appearance of a new lesion(s), unequivocal progression in non-target lesion(s) or at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimetres (mm).
OS was defined as the time from randomization to the date of death from any cause.
| Arm | Type | Description |
|---|---|---|
| Arm A: Atezolizumab+Lurbinectedin | EXPERIMENTAL | 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. |
| Arm B: Atezolizumab | ACTIVE_COMPARATOR | 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. |
| Name | Type | Description |
|---|---|---|
| Atezolizumab | DRUG | 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. |
| Lurbinectedin | DRUG | Lurbinectedin 3.2 mg/m² will be administered intravenously on Day 1 of each 21-day cycle in the maintenance phase. |
| Carboplatin | DRUG | Carboplatin will be administered according to the standard of care treatment for 4 cycles in the induction phase. |
| Etoposide | DRUG | Etoposide will be administered according to the standard of care treatment for 4 cycles in the induction phase. |
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 cytologic...