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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06616532 | PM8002 in Combination With Paclitaxel Compared With Chemotherapy as Second-line Treatment in Small Cell Lung Cancer | PHASE3 | RECRUITING | 404 | — | — | Nov 13, 2024 | Dec 25, 2028 | Dec 19, 2024 | 45 | China |
| NCT05844150 | A Study of PM8002 (Anti-PD-L1/VEGF) in Combination With Chemotherapy in Patients With ES-SCLC | PHASE2 | ACTIVE NOT_RECRUITING | 50 | — | — | Jun 1, 2023 | Dec 1, 2025 | Mar 12, 2025 | 17 | China |
| NCT05879068 | A Study of PM8002 in Combination With Chemotherapy in Patients With SCLC | PHASE2 | ACTIVE NOT_RECRUITING | 99 | — | — | May 27, 2022 | Apr 30, 2026 | Dec 18, 2024 | 11 | China |
Overall survival is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis are censored at the date of the last follow-up.
ORR is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1.
Objective response rate (ORR) is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1.
The incidence and severity of TRAEs graded according to NCI-CTCAE v5.0
| Arm | Type | Description |
|---|---|---|
| PM8002+Paclitaxel | EXPERIMENTAL | Subjects will be administered with PM8002 in combination with Paclitaxel via intravenously (IV) infusion. |
| Chemotherapy | ACTIVE_COMPARATOR | Subjects will be administered with Investigator's Choice(Topotecan or Paclitaxel) via intravenously (IV) infusion Q3W. |
| PM8002+Etoposide＋platinum | EXPERIMENTAL | Subjects will be administered with PM8002 plus Etoposide and platinum via intravenously (IV) Q3W for 4 cycles, followed by PM8002 until progression or for a maximum of 2 years. |
| Name | Type | Description |
|---|---|---|
| PM8002 | DRUG | Following a predefined dose and date. |
| Paclitaxel | DRUG | 175mg/m2 via IV infusion on Day 1 Q3W |
| Topotecan | DRUG | 1.25mg/m2/day via IV infusion on Days 1-5 Q3W |
| Platinum | DRUG | IV infusion |
| Etoposide | DRUG | IV infusion |
Inclusion Criteria: 1. Voluntary participation in this clinical study; full understanding of the study and voluntary signing the informed consent form; willing to follow and abling to complete all trial procedures; 2. Age ≥18 years but ≤75 years; 3. Histologically or cytologically confirmed SCLC; 4...