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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

NCT04033354

Description:

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).

Related Conditions:
  • Adenosquamous Lung Carcinoma
  • Squamous Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

URL:

https://clinicaltrials.gov/show/NCT04033354

Trial Eligibility

Document

Title

  • Brief Title: 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
  • Official Title: A Randomized, Double-Blind, Multicenter, Phase III Clinical Study of HLX10 (Recombinant Anti-PD-1 Humanized Monoclonal Antibody Injection) + Chemotherapy (Carboplatin Nanoparticle Albumin Bound (Nab)-Paclitaxel) vs Chemotherapy (Carboplatin Nab-Paclitaxel) as First-Line Therapy for Locally Advanced or Metastatic Squamous Non Small Cell Lung Cancer (NSCLC)

Clinical Trial IDs

  • ORG STUDY ID: HLX10-004-NSCLC303
  • NCT ID: NCT04033354

Conditions

  • Squamous Non Small Cell Lung Cancer

Interventions

DrugSynonymsArms
HLX10A
carboplatin and nab paclitaxelA
PlaceboB

Purpose

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).

Trial Arms

NameTypeDescriptionInterventions
AExperimentalHLX10 + chemotherapy (carboplatin nab paclitaxel)
  • HLX10
  • carboplatin and nab paclitaxel
BPlacebo ComparatorPlacebo + chemotherapy (carboplatin nab paclitaxel), After 1st PD, the subject will be unblinded by the investigator and be continued with HLX10 monotherapy
  • carboplatin and nab paclitaxel
  • Placebo

Eligibility Criteria

        Inclusion Criteria:

          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.

        Exclusion Criteria:

          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.
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:tumor assessment
Time Frame:Baseline until disease progression or death, whichever occurs first (up to approximately 24months)
Safety Issue:
Description:Progression-free survival (PFS) (assessed by the independent radiology review committee [IRRC] based on Response Evaluation Criteria in Solid Tumors [RECIST] 1.1)

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Shanghai Henlius Biotech

Trial Keywords

  • Locally Advanced or Metastatic
  • Squamous Non Small Cell Lung Cancer

Last Updated

January 29, 2021