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

Who is this study for? Patients with previously untreated extensive stage small cell lung cancer
What treatments are being studied? HLX10+Carboplatin+Etoposide
Status: Completed
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Georgia
Institute for Personalized Medicine
Tbilisi
Poland
Wojew. Wielospecjalistyczne Centrum Onkologii i Traumatologi
Lodz
Russian Federation
Arkhangelsk Clinical Oncology Dispensary
Arkhangelsk
Turkey
Medipol Mega Hospital
Istanbul
Ukraine
Komunalnyi zaklad Miska bahato
Dnipropetrovsk
Time Frame
Start Date: 2019-09-12
Completion Date: 2024-05-07
Participants
Target number of participants: 585
Treatments
Experimental: A
HLX 10+chemotherapy (Carboplatin-Etoposide)
Placebo_comparator: B
Placebo+chemotherapy (Carboplatin-Etoposide)
Sponsors
Leads: Shanghai Henlius Biotech

This content was sourced from clinicaltrials.gov

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