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

  • STATUS
    Recruiting
  • End date
    Jan 3, 2022
  • participants needed
    516
  • sponsor
    Shanghai Henlius Biotech
Updated on 3 February 2021

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%>TPS1%, TPS<1%), Asian population (yes or no), NSCLC stage (stage IIIB/IIIC or stage IV), and carboplatin AUC (5 or 6).

Details
Condition Squamous Non Small Cell Lung Cancer
Treatment Placebo, HLX10, carboplatin and nab paclitaxel
Clinical Study IdentifierNCT04033354
SponsorShanghai Henlius Biotech
Last Modified on3 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Squamous Non Small Cell Lung Cancer?
Do you have any of these conditions: Do you have Squamous Non Small Cell Lung Cancer??
Do you have any of these conditions: Do you have Squamous Non Small Cell Lung Cancer??
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
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
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