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

Sponsor
Shanghai Henlius Biotech (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05354700
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
14
Anticipated Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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)
Anticipated Study Start Date :
Mar 29, 2023
Anticipated Primary Completion Date :
Mar 29, 2024
Anticipated Study Completion Date :
May 29, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: HLX07+HLX10+Chemotherapy

HLX07+HLX 10+Chemotherapy (Carboplatin-Etoposide)

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.

Drug: carboplatin and etoposide
chemotherapeutics

Outcome Measures

Primary Outcome Measures

  1. ORR [up to 2 years]

    Objective response rate by investigator assessment per RECIST 1.1

  2. PFS [Up to 2 years]

    Progression-free survival by investigator assessment per RECIST v1.1

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jilin Cancer Hospital Changchun Jilin China 130000

Sponsors and Collaborators

  • Shanghai Henlius Biotech

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shanghai Henlius Biotech
ClinicalTrials.gov Identifier:
NCT05354700
Other Study ID Numbers:
  • HLX07-SCLC201
First Posted:
Apr 29, 2022
Last Update Posted:
May 4, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Carboplatin
Etoposide

Study Results

No Results Posted as of May 4, 2022