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)

Phase 3

• Conditions: Extensive Stage Small Cell Lung Cancer
• Interventions: Drug: HLX10; Drug: carboplatin and etoposide; Drug: placebo

• Registration Number: NCT04063163
• Lead Sponsor: 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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-17
• Study First Submitted QC: 2019-08-19
• Study First Posted: 2019-08-21
• Study Start: 2019-09-12
• Primary Completion: 2021-10-22
• Status Verified: 2022-03
• Last Update Submitted: 2022-09-28
• Last Update Posted: 2022-09-30
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 585

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	carboplatin and etoposide	HLX 10+chemotherapy (Carboplatin-Etoposide)
B	carboplatin and etoposide	Placebo+chemotherapy (Carboplatin-Etoposide)
A	HLX10	HLX 10+chemotherapy (Carboplatin-Etoposide)
B	placebo	Placebo+chemotherapy (Carboplatin-Etoposide)

Primary Outcome Measures

Name	Time	Method
OS	A period from randomization through death regardless of causality (approximately up to 24 months).	Overall survival (OS)

Trial Locations

Locations (6)

ShanghaiHenliusBiotech; 🇨🇳 Shanghai, China

Institute for Personalized Medicine; 🇬🇪 Tbilisi, Georgia

Wojew. Wielospecjalistyczne Centrum Onkologii i Traumatologi; 🇵🇱 Lodz, Poland

Arkhangelsk Clinical Oncology Dispensary; 🇷🇺 Arkhangelsk, Russian Federation

Medipol Mega Hospital; 🇹🇷 Istanbul, Turkey

Komunalnyi zaklad Miska bahato; 🇺🇦 Dnipropetrovsk, Ukraine