Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
YL201 · 1 trial · 1 indication
OS duration is defined as the difference in time from the date of randomization to the date of death due to any cause. OS was estimated using KM methodology.
PFS, as assessed by Blinded Independent Review Committee (BIRC), is defined as the time from randomization to the first documented progressive disease (PD) based on BIRC imaging assessment, or death from any cause, whichever occurs first.
| Arm | Type | Description |
|---|---|---|
| YL201 in combination with serplulimab | EXPERIMENTAL | Participants will receive YL201 in combination with serplulimab until disease progression or unacceptable toxicity, whichever occurs first. The total number of treatment cycles of YL201 in this study is not fixed, and the maximum duration of serplulimab treatment is 2 years. |
| Carboplatin and etoposide in combination with serplulimab | ACTIVE_COMPARATOR | Participants will receive 4 cycles of carboplatin plus etoposide in combination with serplulimab as induction therapy, followed by maintenance treatment with serplulimab for up to 2 years. |
| Name | Type | Description |
|---|---|---|
| YL201 | DRUG | YL201 will be administered by intravenous infusion at a dose of 2.0 mg/kg on Day 1 of each 3-week cycle. Treatment will continue until disease progression or unacceptable toxicity, whichever occurs first. The total number of treatment cycles of YL201 in this study is not fixed, |
| Serplulimab | DRUG | Serplulimab will be administered by intravenous infusion at a dose of 300mg on Day 1 of each 3-week cycle. Treatment will continue until disease progression or unacceptable toxicity. The maximum treatment duration for serplulimab will be 2 years. |
| Carboplatin | DRUG | Carboplatin will be administered by intravenous infusion at a dose of AUC 5 on Day 1 of each 3-week cycle. Carboplatin treatment will be administered for up to 4 cycles. |
| Etoposide | DRUG | Etoposide will be administered by intravenous infusion at a dose of 100 mg/m2 on Days 1 to 3 of each 3-week cycle. Etoposide treatment will be administered for up to 4 cycles. |
Inclusion Criteria: 1. Voluntarily sign the written informed consent form and comply with the protocol requirements 2. Age ≥18 years. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SC...