A Phase III Study to Investigate Efficacy and Safety of HLX10 + Chemotherapy in Patients With ES-SCLC

Henlius Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Extensive Stage Small Cell Lung Cancer

Treatments: Drug: carboplatin and etoposide; Drug: placebo; Drug: HLX10

Study type: Interventional

Funder types: Industry

Identifiers

NCT04063163

HLX10-005-SCLC301

Details and patient eligibility

About

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)

Full description

After screening, subjects meeting the inclusion criteria and none of the exclusion criteria will be enrolled. Included subjects will be treated with HLX10 or placebo in combination with chemotherapy once every 3 weeks, until disease progression, death, intolerable toxicity, withdrawal of informed consent, or occurrence of other reasons specified in the protocol (whichever occurs first).

Enrollment: 585 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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585 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

HLX 10+chemotherapy (Carboplatin-Etoposide)

Treatment:

Drug: HLX10

Drug: carboplatin and etoposide

B

Placebo Comparator group

Description:

Placebo+chemotherapy (Carboplatin-Etoposide)

Treatment:

Drug: placebo

Drug: carboplatin and etoposide