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)

  • days left to enroll
  • participants needed
  • sponsor
    Shanghai Henlius Biotech
Updated on 17 February 2022
brain metastases


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 Extensive Stage Small Cell Lung Cancer
Treatment Placebo, HLX10, carboplatin and etoposide
Clinical Study IdentifierNCT04063163
SponsorShanghai Henlius Biotech
Last Modified on17 February 2022


Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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