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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05089734 | Study of Sacituzumab Govitecan (SG) Versus Docetaxel in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) | PHASE3 | ACTIVE NOT_RECRUITING | 603 | — | — | Nov 17, 2021 | Jan 1, 2027 | May 7, 2026 | 227 | United States, Australia +18 |
| NCT05186974 | Study of Sacituzumab Govitecan Combinations in First-line Treatment of Participants With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) | PHASE2 | ACTIVE NOT_RECRUITING | 193 | — | — | May 30, 2022 | Sep 1, 2026 | Feb 11, 2026 | 101 | United States, Australia +10 |
OS is defined as the time from the date of randomization until the date of death from any cause. OS was estimated using Kaplan-Meier estimate. Participants without documentation of death were censored on the date they were last known to be alive.
| Arm | Type | Description |
|---|---|---|
| Sacituzumab Govitecan-hziy (SG) | EXPERIMENTAL | Participants will receive SG 10 mg/kg on Days 1 and 8 of a 21-day cycle (ie, 2 weekly doses plus 1 week without treatment) until progressive disease (PD), death, unacceptable toxicity, or another treatment discontinuation criterion is met. |
| Docetaxel | ACTIVE_COMPARATOR | Participants will receive docetaxel 75 mg/m\^2 on Day 1 of a 21-day cycle (ie, once every 3 weeks) until PD, death, unacceptable toxicity, or another treatment discontinuation criterion is met. |
| Sacituzumab Govitecan-hziy (SG) + Pembrolizumab (Cohort A) | EXPERIMENTAL | Participants assigned to Cohorts A according to tumor proportion score (TPS) status will receive SG 10 mg/kg on Days 1 and 8 of a 21-day cycle + pembrolizumab 200 mg on Day 1 of a 21-day cycle. |
| SG + Pembrolizumab (Cohort B) | EXPERIMENTAL | Participants assigned to Cohorts B according to TPS status will receive SG 10 mg/kg on Days 1 and 8 of a 21-day cycle + pembrolizumab 200 mg on Day 1 of a 21-day cycle. |
| SG + Pembrolizumab + Carboplatin Safety Run-in | EXPERIMENTAL | Participants will receive SG (de-escalating dose levels: 10.0 mg/kg, 7.5 mg/kg, or 5.0 mg/kg) on Days 1 and 8 of a 21-day cycle + pembrolizumab 200 mg on Day 1 of a 21-day cycle + carboplatin area under the concentration versus time curve (AUC)5 on Day 1 of a 21-day cycle. |
| SG + Pembrolizumab + Cisplatin Safety Run-in (Optional) | EXPERIMENTAL | Participants will receive SG (either 10 mg/kg or 7.5 mg/kg) on Days 1 and 8 of a 21-day cycle + pembrolizumab 200 mg on Day 1 of a 21-day cycle + cisplatin 75 mg/m\^2 on Day 1 of a 21-day cycle. |
| SG + Pembrolizumab + Carboplatin or Cisplatin (Cohort C) | EXPERIMENTAL | Participants assigned to Cohort C according to disease status will receive SG RP2D as determined during the safety run-in cohorts on Days 1 and 8 of a 21-day cycle + pembrolizumab 200 mg on Day 1 of a 21-day cycle + carboplatin AUC5 or cisplatin 75 mg/m\^2 as determined during the safety run-in cohorts on Day 1 of a 21-day cycle. |
| SG + Pembrolizumab + Carboplatin or Cisplatin (Cohort D) | EXPERIMENTAL | Participants assigned to Cohort D according to disease status will receive SG RP2D as determined during the safety run-in cohorts on Days 1 and 8 of a 21-day cycle + pembrolizumab 200 mg on Day 1 of a 21-day cycle + carboplatin AUC5 or cisplatin 75 mg/m\^2 as determined during the safety run-in cohorts on Day 1 of a 21-day cycle. |
| SG + Pembrolizumab + Cisplatin (Cohort E) | EXPERIMENTAL | Participants assigned to Cohort E will receive SG RP2D, as determined following safety review of Cohorts C and D, on Days 1 and 8 of a 21-day cycle + pembrolizumab 200 mg on Day 1 of a 21-day cycle + cisplatin 75 mg/ m\^2 on Day 1 of a 21-day cycle. |
| Name | Type | Description |
|---|---|---|
| Sacituzumab Govitecan-hziy (SG) | BIOLOGICAL | Administered intravenously |
| Docetaxel | DRUG | Administered intravenously |
| Pembrolizumab | DRUG | Administered intravenously |
| Carboplatin | DRUG | Administered intravenously |
| Cisplatin | DRUG | Administered intravenously |
Key Inclusion Criteria: * Pathologically documented non-small cell lung cancer (NSCLC) with documented evidence of Stage 4 NSCLC disease at the time of enrollment (based on the American Joint Committee on Cancer, Eighth Edition). * Epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase...