Back to resultsA Clinical Study to Evaluate the Efficacy and Safety of HLX07 Combination Therapy in Patients With Extensive Small Cell Lung Cancer
Primary Purpose
Small-cell Lung Cancer
Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
HLX07
HLX10
carboplatin and etoposide
Sponsored by
About this trial
This is an interventional treatment trial for Small-cell Lung Cancer
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
Sites / Locations
- Jilin Cancer Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HLX07+HLX10+Chemotherapy
Arm Description
HLX07+HLX 10+Chemotherapy (Carboplatin-Etoposide)
Outcomes
Primary Outcome Measures
ORR
Objective response rate by investigator assessment per RECIST 1.1
PFS
Progression-free survival by investigator assessment per RECIST v1.1
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05354700
Brief Title
A Clinical Study to Evaluate the Efficacy and Safety of HLX07 Combination Therapy in Patients With Extensive Small Cell Lung Cancer
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)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 29, 2023 (Anticipated)
Primary Completion Date
March 29, 2024 (Anticipated)
Study Completion Date
May 29, 2024 (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
Data Monitoring Committee
No
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small-cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HLX07+HLX10+Chemotherapy
Arm Type
Experimental
Arm Description
HLX07+HLX 10+Chemotherapy (Carboplatin-Etoposide)
Intervention Type
Drug
Intervention Name(s)
HLX07
Intervention Description
HLX07 is a recombinant humanized anti-EGFR monoclonal antibody injection, developed by Shanghai Henlius Biotech, Inc.
Intervention Type
Drug
Intervention Name(s)
HLX10
Intervention Description
HLX10 is a recombinant humanized anti-PD-1 monoclonal antibody injection, developed by Shanghai Henlius Biotech, Inc.
Intervention Type
Drug
Intervention Name(s)
carboplatin and etoposide
Intervention Description
chemotherapeutics
Primary Outcome Measure Information:
Title
ORR
Description
Objective response rate by investigator assessment per RECIST 1.1
Time Frame
up to 2 years
Title
PFS
Description
Progression-free survival by investigator assessment per RECIST v1.1
Time Frame
Up to 2 years
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xuhui Hu, MD
Phone
18618313742
Email
Xuhui_Hu@henlius.com
Facility Information:
Facility Name
Jilin Cancer Hospital
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Cheng, MD
Phone
0431-85872600
Email
jl.cheng@163.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Clinical Study to Evaluate the Efficacy and Safety of HLX07 Combination Therapy in Patients With Extensive Small Cell Lung Cancer
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