A Randomized, Double-blind, Placebo Controlled Phase III Study to Investigate Efficacy and Safety… (NCT04033354) | Clinical Trial Compass
UnknownPhase 3
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
United States, China537 participantsStarted 2019-08-14
Plain-language 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 metastatic squamous NSCLC who have not previously received systemic treatment.
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 nab paclitaxel) Arm B (placebo arm): Placebo + chemotherapy (carboplatin nab paclitaxel) The three stratification factors for randomization include: PD-L1 expression level (Tumor Proportion Scores \[TPS\]≥50%, 50%\>TPS≥1%, TPS\<1%), Asian population (yes or no), NSCLC stage (stage IIIB/IIIC or stage IV), and carboplatin AUC (5 or 6).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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.
What they're measuring
1
tumor assessment
Timeframe: Baseline until disease progression or death, whichever occurs first (up to approximately 24months)