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NCT Number: NCT04063163

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

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)

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Key information

Conditions

Extensive Stage Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Institute for Personalized Medicine, Tbilisi, Georgia

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically or cytologically diagnosed with ES-SCLC (according to the Veterans Administration Lung Study Group staging system).
  • No prior systemic therapy for ES-SCLC
  • Major organs are functioning well
  • Participant must keep contraception

Exclusion criteria

  • Histologically or cytologically confirmed mixed SCLC.
  • Known history of severe allergy to any monoclonal antibody.
  • Known hypersensitivity to carboplatin or etoposide.
  • Pregnant or breastfeeding females.
  • Patients with a known history of psychotropic drug abuse or drug addiction.
  • Patients who have other factors that could lead to the early termination of this study based on the investigator's judgment.

Treatment and study plan

HLX10

Drug

HLX10 is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc.

carboplatin and etoposide

Drug

chemotherapeutics

Placebo

Drug

placebo

Primary outcomes

  1. OS

    Time frame: The period from randomization through death regardless of causality (up to approximately 56 months)

    Overall survival (OS)

Secondary outcomes

  1. Progression Free Survival (PFS) Assessed by IRRC According to RECIST 1.1

    Time frame: From randomization initiation to the first documentation of PD or death regardless of causality, whichever occurs first (up to approximately 56 months).

    PFS is defined as a period from randomization initiation to the first documentation of PD or death regardless of causality (whichever occurs first).

  2. Objective Response Rate

    Time frame: From baseline until PR or CR, whichever occurs first (up to approximately 56 months)

    The ORR is defined as the proportion of subjects with a best overall response of CR or PR, according to RECIST 1.1. The best overall response will be defined as the best response across all time points in the order of CR, PR, SD, PD, and not NE.

  3. Duration of Response

    Time frame: From the first documentation of response (CR or PR) through the first documentation of PD or death, whichever occurs first (up to approximately 56 months).

    DOR is defined as a period from the first documentation of response (CR or PR) through the first documentation of PD or death (whichever occurs first).

Sponsors and collaborators

Lead sponsor

Shanghai Henlius Biotech

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Aug 21, 2019
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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