NCT04063163

A Phase III Study to Investigate Efficacy and Safety of HLX10 + Chemotherapy in Patients With ES-SCLC

A Randomized, Double-Blind, Multicenter, Phase III Study to Compare Efficacy and Safety of HLX10 in Combination With Chemotherapy in Previously Untreated Patients With ES-SCLC

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 585 (actual)
• Sponsor: Shanghai Henlius Biotech · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, multicenter, phase III clinical study to compare the clinical efficacy and safety of HLX10+ Chemotherapy vs placebo+Chemotherapy in Previously Untreated Patients with Extensive Stage Small Cell Lung Cancer. Eligible subjects in this study will be randomized to Arm A or Arm B at 2:1 ratio as follows: Arm A (HLX10 arm): HLX10 + chemotherapy (Carboplatin-Etoposide) ; Arm B (placebo arm): Placebo + chemotherapy (Carboplatin-Etoposide); The three stratification factors for randomization include: PD-L1 expression level (negative, positive, not available), Brain metastasis (yes versus no), Age (≥ 65 years versus \< 65 years)

Detailed description

After screening, subjects meeting the inclusion criteria and none of the exclusion criteria will be enrolled. Included subjects will be treated with HLX10 or placebo in combination with chemotherapy once every 3 weeks, until disease progression, death, intolerable toxicity, withdrawal of informed consent, or occurrence of other reasons specified in the protocol (whichever occurs first).

Conditions

• Extensive Stage Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	HLX10	HLX10 is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc.
DRUG	carboplatin and etoposide	chemotherapeutics
DRUG	placebo	placebo

Timeline

• Start date: 2019-09-12
• Primary completion: 2024-05-07
• Completion: 2024-05-07
• First posted: 2019-08-21
• Last updated: 2025-12-09
• Results posted: 2025-12-09

Locations

5 sites across 5 countries: Georgia, Poland, Russia, Turkey (Türkiye), Ukraine