SCLC, Extensive Stage
Conditions
Brief summary
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.
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,
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.
Sponsors
MediLink Therapeutics (Suzhou) Co., Ltd.
Shanghai Henlius Biotech
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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-SCLC). 5. No prior systemic treatment for ES-SCLC. 6. At least one extracranial measurable lesion according to RECIST v1.1. 7. Adequate organ function. 8. Life expectancy ≥3 months.
Exclusion criteria
1. Any histological types of transformed SCLC or combined SCLC. 2. History of immune-related adverse events (irAEs) of CTCAE Grade ≥3 during prior immunotherapy, or unresolved adverse events from previous antitumor therapy. 3. Major surgery (excluding diagnostic procedures) or severe trauma within 4 weeks prior to randomization or planned major surgery during the study period. 4. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. 5. Presence of active brain metastases, brainstem metastases, or leptomeningeal metastases. 6. Presence of severe and uncontrolled cardiovascular or cerebrovascular disease. 7. History of interstitial lung disease (ILD) /pneumonitis requiring steroid treatment, or current diagnosis of ILD/pneumonitis, or concurrent pulmonary disease leading to clinically severe impairment of respiratory function. 8. Active autoimmune or inflammatory diseases within 2 years prior to randomization. 9. Severe infection within 4 weeks prior to randomization, or active infection requiring intravenous anti-infective therapy within 2 weeks or oral anti-infective therapy within 1 week prior to randomization. 10. Known active tuberculosis or active syphilis infection. 11. History of immunodeficiency or positive for human immunodeficiency virus (HIV) antibodies test. 12. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Participants with inactive HBV infection must receive antiviral therapy throughout the study. 13. History of other primary malignancies within 5 years prior to randomization. 14. Known hypersensitivity to any component of the investigational product. 15. Females who are pregnant or breastfeeding, or who plan to become pregnant or breastfeed during the study period. 16. Any condition that, in the opinion of the investigator, would make the participant unsuitable for study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) as assessed by BIRC | Up to approximately 30 months | 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. |
| Overall survival (OS) | Up to approximately 5 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | Up to approximately 30 months | 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. |
| Disease control rate (DCR) | Up to approximately 30 months | DCR is defined as the percentage of participants with (confirmed) complete response, partial response, or stable disease as assessed according to RECIST v1.1 |
| Duration of response (DOR) | Up to approximately 30 months | 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 to response (TTR) | Up to approximately 30 months | TTR is defined as the time from randomization to the first documented objective response. |
| Treatment Emergent Adverse Event (TEAE) | Up to approximately 30 months | 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. |
| Pharmacokinetic (PK) characteristics | Up to approximately 30 months | PK parameters of YL201 and serplulimab will be evaluated. |
| Anti-drug antibody (ADA) | Up to approximately 30 months | Frequency of anti-YL201 antibody (ADA) will be investigated. |
| Progression-free survival (PFS) as assessed by investigator | Up to approximately 30 months | 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. |
Countries
China
Contacts
CONTACTMediLink Study Team
Outcome results
None listed