A Clinical Study to Evaluate the Efficacy and Safety of HLX07 Combination Therapy in Patients With Extensive Small Cell Lung Cancer
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)
1 other identifier
interventional
20
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2023
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2022
CompletedFirst Posted
Study publicly available on registry
April 29, 2022
CompletedStudy Start
First participant enrolled
March 29, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 29, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 29, 2024
CompletedMay 4, 2022
April 1, 2022
1 year
April 26, 2022
May 3, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
ORR
Objective response rate by investigator assessment per RECIST 1.1
up to 2 years
PFS
Progression-free survival by investigator assessment per RECIST v1.1
Up to 2 years
Study Arms (1)
HLX07+HLX10+Chemotherapy
EXPERIMENTALHLX07+HLX 10+Chemotherapy (Carboplatin-Etoposide)
Interventions
HLX07 is a recombinant humanized anti-EGFR monoclonal antibody injection, developed by Shanghai Henlius Biotech, Inc.
HLX10 is a recombinant humanized anti-PD-1 monoclonal antibody injection, developed by Shanghai Henlius Biotech, Inc.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jilin Cancer Hospital
Changchun, Jilin, 130000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2022
First Posted
April 29, 2022
Study Start
March 29, 2023
Primary Completion
March 29, 2024
Study Completion
May 29, 2024
Last Updated
May 4, 2022
Record last verified: 2022-04