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

Phase 2

• Conditions: Small-cell Lung Cancer
• Interventions: Drug: HLX07; Drug: HLX10; Drug: carboplatin and etoposide

• Registration Number: NCT05354700
• Lead Sponsor: Shanghai Henlius Biotech

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-04
• Study First Submitted: 2022-04-26
• Study First Submitted QC: 2022-04-26
• Study First Posted: 2022-04-29
• Last Update Submitted: 2022-05-03
• Last Update Posted: 2022-05-04
• Study Start: 2023-03-29
• Primary Completion: 2024-03-29
• Study Completion: 2024-05-29

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HLX07+HLX10+Chemotherapy	carboplatin and etoposide	HLX07+HLX 10+Chemotherapy (Carboplatin-Etoposide)
HLX07+HLX10+Chemotherapy	HLX07	HLX07+HLX 10+Chemotherapy (Carboplatin-Etoposide)
HLX07+HLX10+Chemotherapy	HLX10	HLX07+HLX 10+Chemotherapy (Carboplatin-Etoposide)

Primary Outcome Measures

Name	Time	Method
PFS	Up to 2 years	Progression-free survival by investigator assessment per RECIST v1.1
ORR	up to 2 years	Objective response rate by investigator assessment per RECIST 1.1

Trial Locations

Locations (1)

Jilin Cancer Hospital; 🇨🇳 Changchun, Jilin, China