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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05671510 | ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors | PHASE3 | RECRUITING | 630 | — | — | Jun 28, 2023 | Aug 31, 2028 | Apr 29, 2026 | 152 | United States, Australia +10 |
OS is defined as the time from randomization to the date of death by any cause. Kaplan-Meier estimates of median OS time will be presented by treatment arm with two sided 95% CIs.
| Arm | Type | Description |
|---|---|---|
| Arm 1: Gotistobart 6 mg/kg with 2 loading doses of 10 mg/kg, Q3W | EXPERIMENTAL | Gotistobart will be administrated by IV infusion in 60 minutes on day 1 of each cycle. A cycle is 21 days. |
| Arm 2: Docetaxel 75 mg/m2, Q3W | ACTIVE_COMPARATOR | Docetaxel will be administrated by IV infusion in 60 minutes on day 1 of each cycle. A cycle is 21 days. |
| Name | Type | Description |
|---|---|---|
| Gotistobart | DRUG | Gotistobart will be administrated through IV infusion over 60 minutes, once every 21 days in assigned dose. |
| Docetaxel | DRUG | Docetaxel will be administrated through IV infusion over 60 minutes, once every 21 days in 75mg/m2 dose. |
Inclusion Criteria (Major criteria): 1. Adult (≥ 18 years), all genders, capable of signing informed consent. 2. Histologically- or cytologically- confirmed diagnosis of metastatic squamous NSCLC, metastasis can be regional lymph nodes or distant organs. 3. Radiographic progression after treatment ...