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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

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ClinicalTrials.gov Identifier: NCT04033354
Recruitment Status : Active, not recruiting
First Posted : July 26, 2019
Last Update Posted : August 8, 2023
Sponsor:
Information provided by (Responsible Party):
Shanghai Henlius Biotech

Study Description
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Brief 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).


Condition or disease Intervention/treatment Phase
Squamous Non Small Cell Lung Cancer Drug: HLX10 Drug: carboplatin and nab paclitaxel Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 537 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : August 14, 2019
Estimated Primary Completion Date : December 30, 2023
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: A
HLX10 + chemotherapy (carboplatin nab paclitaxel)
 Drug: HLX10
HLX10 is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc.

Drug: carboplatin and nab paclitaxel
chemotherapeutics
Placebo Comparator: B
Placebo + chemotherapy (carboplatin nab paclitaxel), After 1st PD, the subject will be unblinded by the investigator and be continued with HLX10 monotherapy
 Drug: carboplatin and nab paclitaxel
chemotherapeutics

Drug: Placebo
Placebo


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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04033354


Locations
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Sponsors and Collaborators
Shanghai Henlius Biotech
More Information
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Responsible Party: Shanghai Henlius Biotech
ClinicalTrials.gov Identifier: NCT04033354    
Other Study ID Numbers: HLX10-004-NSCLC303
First Posted: July 26, 2019    Key Record Dates
Last Update Posted: August 8, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai Henlius Biotech:
Locally Advanced or Metastatic
Squamous Non Small Cell Lung Cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
 Bronchial Neoplasms
Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action