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)
Launched by SHANGHAI HENLIUS BIOTECH · Aug 19, 2019
Trial Information
Current as of April 27, 2025
Unknown status
Keywords
ClinConnect Summary
No description provided
Gender
ALL
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.
About Shanghai Henlius Biotech
Shanghai Henlius Biotech, Inc. is a leading biopharmaceutical company based in Shanghai, China, specializing in the research, development, and commercialization of innovative monoclonal antibodies and biosimilars. With a strong focus on oncology and autoimmune diseases, Henlius leverages advanced biotechnological platforms to create effective therapeutic solutions that enhance patient outcomes. The company is committed to high standards of quality and compliance in clinical trials, driven by a mission to improve global healthcare through accessible and affordable biologic therapies. Henlius operates with a robust pipeline of products in various stages of development, aiming to make significant contributions to the evolving landscape of biopharmaceuticals.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Arkhangelsk, , Russian Federation
Istanbul, , Turkey
Shanghai, , China
Tbilisi, , Georgia
Lodz, , Poland
Dnipropetrovsk, , Ukraine
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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