This trial is a registrational Phase III, randomized, open-label, multicenter study to compare the efficacy and safety of YL201 in combination with serplulimab versus standard-of-care carboplatin and etoposide in combination with serplulimab as first-line treatment in patients with extensive-stage small cell lung cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
442
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 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 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.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGLiaoning Cancer Hospital & Institute
Shenyang, Liaoning, China
RECRUITINGOverall 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
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
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
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
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
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.
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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.
Time frame: Up to approximately 30 months
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
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
Pharmacokinetic (PK) characteristics
PK parameters of YL201 and serplulimab will be evaluated.
Time frame: Up to approximately 30 months
Anti-drug antibody (ADA)
Frequency of anti-YL201 antibody (ADA) will be investigated.
Time frame: Up to approximately 30 months