Status:
COMPLETED
A Phase III Study to Investigate Efficacy and Safety of HLX10 + Chemotherapy in Patients With ES-SCLC
Lead Sponsor:
Shanghai Henlius Biotech
Conditions:
Extensive Stage Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 wi...
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 o...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 7 2024
Estimated Enrollment :
585 Patients enrolled
Trial Details
Trial ID
NCT04063163
Start Date
September 12 2019
End Date
May 7 2024
Last Update
December 9 2025
Active Locations (5)
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1
Institute for Personalized Medicine
Tbilisi, Georgia
2
Wojew. Wielospecjalistyczne Centrum Onkologii i Traumatologi
Lodz, Poland
3
Arkhangelsk Clinical Oncology Dispensary
Arkhangelsk, Russia
4
Medipol Mega Hospital
Istanbul, Turkey (Türkiye)