Clareo Health | 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
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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Shanghai Henlius Biotech
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Patients with histologically or cytologically confirmed stage IIIB/IIIC and stage IV (AJCC Edition 8) squamous NSCLC where surgery or radiotherapy cannot be performed.
2. No known sensitizing EGFR mutations or ALK, ROS1 gene rearrangements.
3. Major organs are functioning well
4. Participant must keep contraception
5. Patients with prior denosumab use who can agree to switch to bisphosphonate therapy for bone metastases in the study.
You may not be if
1. 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.
2. Patients with known history of severe hypersensitivity to any monoclonal antibody.
3. Patients with known hypersensitivity to any compositions of carboplatin or nab-paclitaxel.
4. Pregnant or breastfeeding females.
5. Patients with a known history of psychotropic drug abuse or drug addiction; or a history of alcohol abuse.
6. Patients who have other factors that could lead to the early termination of this study based on the investigator's judgment.
