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)

September 28, 2022 updated by: Shanghai Henlius Biotech

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)

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)

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

585

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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: placebo
placebo
Drug: carboplatin and etoposide
chemotherapeutics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: A period from randomization through death regardless of causality (approximately up to 24 months).
Overall survival (OS)
A period from randomization through death regardless of causality (approximately up to 24 months).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Henlius Biotech

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2019

Primary Completion (Actual)

October 22, 2021

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

August 17, 2019

First Submitted That Met QC Criteria

August 19, 2019

First Posted (Actual)

August 21, 2019

Study Record Updates

Last Update Posted (Actual)

September 30, 2022

Last Update Submitted That Met QC Criteria

September 28, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HLX10-005-SCLC301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Extensive Stage Small Cell Lung Cancer

Clinical Trials on placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe