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)

• ClinicalTrials.gov Identifier: NCT04063163
• Recruitment Status: Unknown
• First Posted: August 21, 2019
• Last Update Posted: September 30, 2022
• Sponsor: Shanghai Henlius Biotech
• Information provided by (Responsible Party): Shanghai Henlius Biotech

Tracking Information

• First Submitted Date: August 17, 2019
• First Posted Date: August 21, 2019
• Last Update Posted Date: September 30, 2022
• Actual Study Start Date: September 12, 2019
• Actual Primary Completion Date: October 22, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 14, 2020)

OS [ Time Frame: A period from randomization through death regardless of causality (approximately up to 24 months). ]

Overall survival (OS)

Original Primary Outcome Measures (submitted: August 19, 2019)

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)

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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)
• 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)

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)

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Extensive Stage Small Cell Lung Cancer

Intervention

• 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

Study Arms

• Experimental: A
  HLX 10+chemotherapy (Carboplatin-Etoposide)
  Interventions:

  • Drug: HLX10
  • Drug: carboplatin and etoposide
• Placebo Comparator: B
  Placebo+chemotherapy (Carboplatin-Etoposide)
  Interventions:

  • Drug: carboplatin and etoposide
  • Drug: placebo

• Publications *: Cheng Y, Han L, Wu L, Chen J, Sun H, Wen G, Ji Y, Dvorkin M, Shi J, Pan Z, Shi J, Wang X, Bai Y, Melkadze T, Pan Y, Min X, Viguro M, Li X, Zhao Y, Yang J, Makharadze T, Arkania E, Kang W, Wang Q, Zhu J; ASTRUM-005 Study Group. Effect of First-Line Serplulimab vs Placebo Added to Chemotherapy on Survival in Patients With Extensive-Stage Small Cell Lung Cancer: The ASTRUM-005 Randomized Clinical Trial. JAMA. 2022 Sep 27;328(12):1223-1232. doi: 10.1001/jama.2022.16464.

Recruitment Information

• Recruitment Status: Unknown status
• Actual Enrollment (submitted: September 28, 2022): 585
• Original Estimated Enrollment (submitted: August 19, 2019): 489
• Estimated Study Completion Date: December 2022
• Actual Primary Completion Date: October 22, 2021 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China, Georgia, Poland, Russian Federation, Turkey, Ukraine

Administrative Information

• NCT Number: NCT04063163
• Other Study ID Numbers: HLX10-005-SCLC301
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Shanghai Henlius Biotech
• Original Responsible Party: Same as current
• Current Study Sponsor: Shanghai Henlius Biotech
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Shanghai Henlius Biotech
• Verification Date: March 2022