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A Randomized, Double-blind, Placebo Controlled Phase III Study to Investigate Efficacy and Safety of HLX10 + Chemotherapy (Carboplatin- Etoposide) in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04063163
Recruitment Status : Recruiting
First Posted : August 21, 2019
Last Update Posted : December 17, 2020
Information provided by (Responsible Party):
Shanghai Henlius Biotech

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)

Condition or disease Intervention/treatment Phase
Extensive Stage Small Cell Lung Cancer Drug: HLX10 Drug: carboplatin and etoposide Drug: placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 567 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Multicenter, Phase III Study to Compare Clinical Efficacy and Safety of HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) in Combination With Chemotherapy (Carboplatin-Etoposide) in Previously Untreated Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC)
Actual Study Start Date : September 12, 2019
Estimated Primary Completion Date : December 23, 2022
Estimated Study Completion Date : December 23, 2022

Arm Intervention/treatment
Experimental: A
HLX 10+chemotherapy (Carboplatin-Etoposide)
Drug: HLX10
HLX10 is an innovative monoclonal antibody targeting PD-1,developed by Shanghai Henlius Biotech, Inc.

Drug: carboplatin and etoposide

Placebo Comparator: B
Placebo+chemotherapy (Carboplatin-Etoposide)
Drug: carboplatin and etoposide

Drug: placebo

Primary Outcome Measures :
  1. OS [ Time Frame: A period from randomization through death regardless of causality (approximately up to 24 months). ]
    Overall survival (OS)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04063163

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Contact: Celine Zhang, Master +86 15922119006

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ShanghaiHenliusBiotech Recruiting
Shanghai, China
Contact: Celine Zhang, Master    +8615922119006      
Sponsors and Collaborators
Shanghai Henlius Biotech
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Responsible Party: Shanghai Henlius Biotech Identifier: NCT04063163    
Other Study ID Numbers: HLX10-005-SCLC301
First Posted: August 21, 2019    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai Henlius Biotech:
Extensive Stage
Small Cell Lung Cancer
Anti-PD-1 Monoclonal Antibody
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action