A Study of YL201 in Combination With Serplulimab in Participants With Treatment-naïve Extensive-stage Small Cell Lung Cancer

Lead sponsor

MediLink Therapeutics (Suzhou) Co., Ltd. is the lead sponsor of 23 studies on the registry; 18 are open to participants now.

Study arms

• Experimental
  YL201 in combination with serplulimab

  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.

  Drug: YL201 · Drug: Serplulimab

• Active comparator
  Carboplatin and etoposide in combination with serplulimab

  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.

  Drug: Serplulimab · Drug: Carboplatin · Drug: Etoposide

Interventions

• DrugYL201

  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,

  Also known as: Tam-Peli, Tambotatug Pelitecan

• DrugSerplulimab

  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.

• DrugCarboplatin

  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.

• DrugEtoposide

  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.

Primary outcomes

1. Overall survival (OS)

   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.

   Time frame: Up to approximately 5 years

2. Progression-free survival (PFS) as assessed by BIRC

   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.

   Time frame: Up to approximately 30 months

Secondary outcomes

1. Progression-free survival (PFS) as assessed by investigator

   PFS assessed by investigator is defined as the time from randomization to the first documented PD based on investigator assessment, or death from any cause, whichever occurs first.

   Time frame: Up to approximately 30 months

2. Objective response rate (ORR)

   ORR is defined as the percentage of participants with (confirmed) complete response or partial response as assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

   Time frame: Up to approximately 30 months

3. Disease control rate (DCR)

   DCR is defined as the percentage of participants with (confirmed) complete response, partial response, or stable disease as assessed according to RECIST v1.1

   Time frame: Up to approximately 30 months

4. Duration of response (DOR)

   DOR is defined as the time from the first documented objective response to the first documented disease progression or death from any cause, whichever occurs first.

   Time frame: Up to approximately 30 months

5. Time to response (TTR)

   TTR is defined as the time from randomization to the first documented objective response.

   Time frame: Up to approximately 30 months

6. Treatment Emergent Adverse Event (TEAE)

   Treatment-emergent adverse events (TEAEs) are defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new onset or worsening) that occurs after initiation of YL201, or any worsening of a pre-existing condition during YL201 treatment. TEAEs will be graded and summarized by type, frequency, and severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 6.0.

   Time frame: Up to approximately 30 months

7. Pharmacokinetic (PK) characteristics

   PK parameters of YL201 and serplulimab will be evaluated.

   Time frame: Up to approximately 30 months

8. Anti-drug antibody (ADA)

   Frequency of anti-YL201 antibody (ADA) will be investigated.

   Time frame: Up to approximately 30 months