A Randomized, Double-blind, Placebo Controlled Phase III Study to Investigate Efficacy and Safety of HLX10 + Chemotherapy (Carboplatin- Etoposide) in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC)

• Status: Recruiting
• Trial end date: 2022-12-23
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, double-blind, multicenter, phase III clinical study to compare the clinical efficacy and safety of HLX10+ Chemotherapy vs placebo+Chemotherapy in Previously Untreated Patients with Extensive Stage Small Cell Lung Cancer.

Eligible subjects in this study will be randomized to Arm A or Arm B at 2:1 ratio as follows:

Arm A (HLX10 arm): HLX10 + chemotherapy (Carboplatin-Etoposide) ; Arm B (placebo arm):

Placebo + chemotherapy (Carboplatin-Etoposide); The three stratification factors for randomization include: PD-L1 expression level (negative, positive, not available), Brain metastasis (yes versus no), Age (≥ 65 years versus < 65 years)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Henlius Biotech
• Treatments: Antibodies; Antibodies, Monoclonal; Antineoplastic Agents, Immunological; Carboplatin; Etoposide; Etoposide phosphate

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.