A Clinical Study to Evaluate the Efficacy and Safety of HLX07 Combination Therapy in Patients With Extensive Small Cell Lung Cancer

May 3, 2022 updated by: Shanghai Henlius Biotech

An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) + HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) + Chemotherapy in Patients With Extensive Small Cell Lung Cancer (ES-SCLC)

This study is conducted in patients with advanced metastatic small cell lung cancer (SCLC). This study includes a single arm: the patients will receive HLX07 combination therapy with HLX10 and chemotherapy (carboplatin+etoposide) as first-line treatment. All of eligible patients will receive study drug treatment until loss of clinical benefit, unacceptable toxicity, death, withdrawal of informed consent (whichever occurs first, HLX10 treatment up to 2 years).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

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
    • Jilin
      • Changchun, Jilin, China, 130000
        • Jilin Cancer Hospital
        • Contact:

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HLX07+HLX10+Chemotherapy
HLX07+HLX 10+Chemotherapy (Carboplatin-Etoposide)
Drug: carboplatin and etoposide
chemotherapeutics
Drug: HLX07
HLX07 is a recombinant humanized anti-EGFR monoclonal antibody injection, developed by Shanghai Henlius Biotech, Inc.
Drug: HLX10
HLX10 is a recombinant humanized anti-PD-1 monoclonal antibody injection, developed by Shanghai Henlius Biotech, Inc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: up to 2 years
Objective response rate by investigator assessment per RECIST 1.1
up to 2 years
PFS
Time Frame: Up to 2 years
Progression-free survival by investigator assessment per RECIST v1.1
Up to 2 years

Collaborators and Investigators

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

Sponsor

Shanghai Henlius Biotech

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 (Anticipated)

March 29, 2023

Primary Completion (Anticipated)

March 29, 2024

Study Completion (Anticipated)

May 29, 2024

Study Registration Dates

First Submitted

April 26, 2022

First Submitted That Met QC Criteria

April 26, 2022

First Posted (Actual)

April 29, 2022

Study Record Updates

Last Update Posted (Actual)

May 4, 2022

Last Update Submitted That Met QC Criteria

May 3, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HLX07-SCLC201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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.

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