OncRef

Clinical Trial: NCT04063163

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

Status:

COMPLETED

Phase:

Phase 3

Lead Sponsor:Shanghai Henlius Biotech
Information Provided By:Shanghai Henlius Biotech
Last Update Posted:2025-12-09

Study Overview

Brief 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)

Official Title

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

Conditions

Extensive Stage Small Cell Lung Cancer

Intervention / Treatment

  • Drug: HLX10
  • Drug: carboplatin and etoposide
  • Drug: placebo

Other Study ID Numbers

  • HLX10-005-SCLC301

Start Date (Actual)

2019-09-12

Primary Completion Date (Actual)

2024-05-07

Study Completion Date (Actual)

2024-05-07

Enrollment (Actual)

585

Study Type

Interventional

Phase

Phase 3