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UnknownPhase 3NCT04033354
Official study 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

Study 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).

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedHLX10 and carboplatin and nab paclitaxel

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · PD-L1 · Locally advanced

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 8, 2023 · Source: ClinicalTrials.gov

Is enrollment open?Unknown

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 3

Interventional

Where is it offered?92 U.S. locations

Locations may change over time.

Who runs it?Shanghai Henlius Biotech

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
Shanghai Henlius Biotech
Interventions being studied
Drug: HLX10; Drug: carboplatin and nab paclitaxel; Drug: Placebo
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Locally advanced→Metastatic or stage IV→
Biomarkers
PD-L1→
Treatment approach
Chemotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Oncology and Hematology Associates of Southwest VirginiaRoanoke, Virginia
  • Anhui Medical University - The Second HospitalHefei, Anhui
  • Anhui Provincial HospitalHefei, Anhui
  • The First Affiliated Hospital Of Anhui Medical UniversityHefei, Anhui
  • The Second Affiliated Hospital of Anhui Medical UniversityHefei, Anhui
  • Beijing Chaoyang HospitalBeijing, Beijing Municipality
  • Beijing Friendship HospitalBeijing, Beijing Municipality
  • Peking University First HospitalBeijing, Beijing Municipality
  • Daping HospitalChongqing, Chongqing Municipality
  • The Second Affiliated Hospital of Army Medical University,PLAChongqing, Chongqing Municipality
  • Fujian Medical University Union HospitalFuzhou, Fujian
  • Fujian Provincial Cancer HospitalFuzhou, Fujian

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 8, 2023. Always confirm current availability with the study team.

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