Status:
UNKNOWN
A Randomized, Double-blind, Placebo Controlled Phase III Study to Investigate Efficacy and Safety of First-Line Treatment With HLX10 + Chemotherapy (Carboplatin-Nanoparticle Albumin Bound (Nab) Paclitaxel) in Patients With Stage IIIB/IIIC or IV NSCLC
Lead Sponsor:
Shanghai Henlius Biotech
Conditions:
Squamous Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study is a randomized, double-blind, multicenter, phase III clinical study to compare the clinical efficacy and safety of HLX10 + chemotherapy vs chemotherapy in subjects with locally advanced or...
Eligibility Criteria
Inclusion
- Patients with histologically or cytologically confirmed stage IIIB/IIIC and stage IV (AJCC Edition 8) squamous NSCLC where surgery or radiotherapy cannot be performed.
- No known sensitizing EGFR mutations or ALK, ROS1 gene rearrangements.
- Major organs are functioning well
- Participant must keep contraception
- Patients with prior denosumab use who can agree to switch to bisphosphonate therapy for bone metastases in the study.
Exclusion
- Patients with histologically non-squamous NSCLC. Mixed tumors will be classified according to the primary cell type. Patients do not meet the requirements for enrollment if small cell components and neuroendocrine carcinoma components are present. For non-small cell histology, patients meet the requirements for enrollment if squamous components (e.g., adenosquamous) are present.
- Patients with known history of severe hypersensitivity to any monoclonal antibody.
- Patients with known hypersensitivity to any compositions of carboplatin or nab-paclitaxel.
- Pregnant or breastfeeding females.
- Patients with a known history of psychotropic drug abuse or drug addiction; or a history of alcohol abuse.
- 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 :
August 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2023
Estimated Enrollment :
537 Patients enrolled
Trial Details
Trial ID
NCT04033354
Start Date
August 14 2019
End Date
December 30 2023
Last Update
August 8 2023
Active Locations (92)
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1
Oncology and Hematology Associates of Southwest Virginia
Roanoke, Virginia, United States, 24014
2
Anhui Medical University - The Second Hospital
Hefei, Anhui, China
3
Anhui Provincial Hospital
Hefei, Anhui, China
4
The First Affiliated Hospital Of Anhui Medical University
Hefei, Anhui, China