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

NCT04063163 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 585

Last updated 2025-12-09

Study results available
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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)

Conditions

Interventions

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-12
Primary Completion
2024-05-07
Completion
2024-05-07

Countries

  • Georgia
  • Poland
  • Russia
  • Turkey (Türkiye)
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04063163 on ClinicalTrials.gov