A Randomized, Double-Blind, Multicenter, Phase III Study to Compare Efficacy and Safety of HLX10 in Combination With Chemotherapy in Previously Untreated Patients With ES-SCLC
Overview
- Phase
- Phase 3
- Intervention
- HLX10
- Conditions
- Extensive Stage Small Cell Lung Cancer
- Sponsor
- Shanghai Henlius Biotech
- Enrollment
- 585
- Locations
- 5
- Primary Endpoint
- OS
- Status
- Completed
- Last Updated
- 4 months ago
Overview
Brief 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)
Detailed 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).
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
A
HLX 10+chemotherapy (Carboplatin-Etoposide)
Intervention: HLX10
A
HLX 10+chemotherapy (Carboplatin-Etoposide)
Intervention: carboplatin and etoposide
B
Placebo+chemotherapy (Carboplatin-Etoposide)
Intervention: carboplatin and etoposide
B
Placebo+chemotherapy (Carboplatin-Etoposide)
Intervention: placebo
Outcomes
Primary Outcomes
OS
Time Frame: The period from randomization through death regardless of causality (up to approximately 56 months)
Overall survival (OS)
Secondary Outcomes
- Progression Free Survival (PFS) Assessed by IRRC According to RECIST 1.1(From randomization initiation to the first documentation of PD or death regardless of causality, whichever occurs first (up to approximately 56 months).)
- Objective Response Rate(From baseline until PR or CR, whichever occurs first (up to approximately 56 months))
- Duration of Response(From the first documentation of response (CR or PR) through the first documentation of PD or death, whichever occurs first (up to approximately 56 months).)