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)
Overview
- Phase
- Phase 2
- Intervention
- HLX07
- Conditions
- Small-cell Lung Cancer
- Sponsor
- Shanghai Henlius Biotech
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- PFS
- Last Updated
- 3 years ago
Overview
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).
Investigators
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
Arms & Interventions
HLX07+HLX10+Chemotherapy
HLX07+HLX 10+Chemotherapy (Carboplatin-Etoposide)
Intervention: HLX07
HLX07+HLX10+Chemotherapy
HLX07+HLX 10+Chemotherapy (Carboplatin-Etoposide)
Intervention: HLX10
HLX07+HLX10+Chemotherapy
HLX07+HLX 10+Chemotherapy (Carboplatin-Etoposide)
Intervention: carboplatin and etoposide
Outcomes
Primary Outcomes
PFS
Time Frame: Up to 2 years
Progression-free survival by investigator assessment per RECIST v1.1
ORR
Time Frame: up to 2 years
Objective response rate by investigator assessment per RECIST 1.1