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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)

Primary Purpose

Extensive Stage Small Cell Lung Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
HLX10
carboplatin and etoposide
placebo
Sponsored by
Shanghai Henlius Biotech
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extensive Stage Small Cell Lung Cancer focused on measuring Extensive Stage, Small Cell Lung Cancer, Anti-PD-1 Monoclonal Antibody

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • ShanghaiHenliusBiotech
  • Institute for Personalized Medicine
  • Wojew. Wielospecjalistyczne Centrum Onkologii i Traumatologi
  • Arkhangelsk Clinical Oncology Dispensary
  • Medipol Mega Hospital
  • Komunalnyi zaklad Miska bahato

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A

B

Arm Description

HLX 10+chemotherapy (Carboplatin-Etoposide)

Placebo+chemotherapy (Carboplatin-Etoposide)

Outcomes

Primary Outcome Measures

OS
Overall survival (OS)

Secondary Outcome Measures

Full Information

First Posted
August 17, 2019
Last Updated
September 28, 2022
Sponsor
Shanghai Henlius Biotech
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1. Study Identification

Unique Protocol Identification Number
NCT04063163
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 12, 2019 (Actual)
Primary Completion Date
October 22, 2021 (Actual)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Henlius Biotech

4. Oversight

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

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extensive Stage Small Cell Lung Cancer
Keywords
Extensive Stage, Small Cell Lung Cancer, Anti-PD-1 Monoclonal Antibody

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
585 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
HLX 10+chemotherapy (Carboplatin-Etoposide)
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Placebo+chemotherapy (Carboplatin-Etoposide)
Intervention Type
Drug
Intervention Name(s)
HLX10
Intervention Description
HLX10 is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc.
Intervention Type
Drug
Intervention Name(s)
carboplatin and etoposide
Intervention Description
chemotherapeutics
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
OS
Description
Overall survival (OS)
Time Frame
A period from randomization through death regardless of causality (approximately up to 24 months).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
ShanghaiHenliusBiotech
City
Shanghai
Country
China
Facility Name
Institute for Personalized Medicine
City
Tbilisi
Country
Georgia
Facility Name
Wojew. Wielospecjalistyczne Centrum Onkologii i Traumatologi
City
Lodz
Country
Poland
Facility Name
Arkhangelsk Clinical Oncology Dispensary
City
Arkhangelsk
Country
Russian Federation
Facility Name
Medipol Mega Hospital
City
Istanbul
Country
Turkey
Facility Name
Komunalnyi zaklad Miska bahato
City
Dnipropetrovsk
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36166026
Citation
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.
Results Reference
derived
Links:
URL
https://jamanetwork.com/journals/jama/article-abstract/2796691?resultClick=1
Description
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.

Learn more about this trial

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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