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).
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
Drug | Synonyms | Arms |
---|
HLX10 | | A |
carboplatin and nab paclitaxel | | A |
Placebo | | B |
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
Name | Type | Description | Interventions |
---|
A | Experimental | HLX10 + chemotherapy (carboplatin nab paclitaxel) | - HLX10
- carboplatin and nab paclitaxel
|
B | Placebo Comparator | Placebo + 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