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Trial record 1 of 1 for:    hlx10-005
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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)

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ClinicalTrials.gov Identifier: NCT04063163
Recruitment Status : Recruiting
First Posted : August 21, 2019
Last Update Posted : November 12, 2019
Sponsor:
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 : 489 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 : September 17, 2021
Estimated Study Completion Date : December 17, 2021


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
chemotherapeutics

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

Drug: placebo
placebo




Primary Outcome Measures :
  1. tumor assessment [ Time Frame: Baseline until disease progression or death, whichever occurs first(up to approximately 24months) ]
    Progression-free survival (PFS) (assessed by the independent radiology review committee [IRRC] based on Response Evaluation Criteria in Solid Tumors [RECIST] 1.1)



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT04063163


Contacts
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Contact: Wei Sun, PhD 1(713)4103224 dsun@henlius.com
Contact: Qiong Wang, Master +8618627113916 Qiong_Wang@henlius.com.cn

Locations
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China
Sun Wei Recruiting
Shanghai, China
Contact: Wei Sun    1(713)4103224      
Sponsors and Collaborators
Shanghai Henlius Biotech
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Responsible Party: Shanghai Henlius Biotech
ClinicalTrials.gov Identifier: NCT04063163    
Other Study ID Numbers: HLX10-005-SCLC301
First Posted: August 21, 2019    Key Record Dates
Last Update Posted: November 12, 2019
Last Verified: August 2019
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
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Carboplatin
Etoposide
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action