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)

Extensive Stage Small Cell Lung Cancer Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04063163
• Other study ID #: HLX10-005-SCLC301
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: September 12, 2019
• Est. completion date: December 2022

Study information

• Verified date: March 2022
• Source: Shanghai Henlius Biotech
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 585
• Est. completion date: December 2022
• Est. primary completion date: October 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Extensive Stage Small Cell Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• HLX10
HLX10 is an innovative monoclonal antibody targeting PD-1,developed by Shanghai Henlius Biotech, Inc.
• carboplatin and etoposide
chemotherapeutics
• placebo
placebo

Locations

Country	Name	City	State
China	ShanghaiHenliusBiotech	Shanghai
Georgia	Institute for Personalized Medicine	Tbilisi
Poland	Wojew. Wielospecjalistyczne Centrum Onkologii i Traumatologi	Lodz
Russian Federation	Arkhangelsk Clinical Oncology Dispensary	Arkhangelsk
Turkey	Medipol Mega Hospital	Istanbul
Ukraine	Komunalnyi zaklad Miska bahato	Dnipropetrovsk

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Henlius Biotech

Countries where clinical trial is conducted

China,  Georgia,  Poland,  Russian Federation,  Turkey,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OS	Overall survival (OS)	A period from randomization through death regardless of causality (approximately up to 24 months).

External Links

•   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;328(12):1223-1232. doi:10.1001/jama.2022.16464.
•   Serplulimab, a novel anti-PD-1 antibody, plus chemotherapy versus chemotherapy alone as first-line treatment for extensive-stage small-cell lung cancer: An international randomized phase 3 study.