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

Henlius Pharmaceuticals

Status and phase

Not yet enrolling

Phase 2

Conditions

Small-cell Lung Cancer

Treatments

Drug: HLX07

Drug: carboplatin and etoposide

Drug: HLX10

Study type

Interventional

Funder types

Industry

Identifiers

NCT05354700

HLX07-SCLC201

Details and patient eligibility

About

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).

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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