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HLX43

Clinical trials are investigating HLX43 in people with advanced non-small cell lung cancer (NSCLC). These studies aim to evaluate how well it works and how safe it is, especially in adults with advanced disease. The main trial listed is a Phase 2 study.

Table of Contents

Trial overview

The listed study is a clinical trial of HLX43 in people with advanced non-small cell lung cancer (NSCLC).[1] It is an interventional study, which means researchers give the study treatment and then measure what happens.[1]

The trial title says it is a global safety and effectiveness study, and the brief summary says it aims to evaluate the clinical efficacy of HLX43 in advanced NSCLC.[1]

Who the study is for

This trial is for people with advanced non-small cell lung cancer (NSCLC).[1] The source data does not list more detailed entry rules, such as age limits or prior treatments, so those details are not available here.[1]

The study plans to enroll 243 participants, which means up to 243 people are expected to join if they meet the study rules.[1]

What the study measures

The main outcome is objective response rate (ORR).[1] ORR shows how many people have a measurable cancer response, such as the tumor getting smaller, based on scan review.[1]

The study uses Blinded Independent Central Review (BICR) and RECIST v1.1 to assess the response.[1] BICR means independent reviewers look at the scans without knowing which treatment was given, and RECIST v1.1 is a standard system for measuring tumor changes.[1]

Trial phase and design

The study is in Phase 2.[1] Phase 2 trials usually focus on whether a treatment may work in a specific disease while continuing to collect safety information.[1]

The trial status is listed as Authorised.[1] This means the study has been approved to proceed according to the source data.[1]

The intervention is listed as HLX43 for Injection given by intravenous administration, which means it is given through a vein.[1]

What the results may mean

This trial is designed to show whether HLX43 can produce a measurable cancer response in advanced NSCLC.[1] Because the study is still in Phase 2, it is part of the process of learning more about the treatment in a defined patient group.[1]

The available data does not report study results yet, so the article can only describe the trial plan, not the outcome.[1]

Trial ID Phase Condition studied Status Enrollment
NCT06907615 Phase 2 Advanced non-small cell lung cancer (NSCLC) Authorised 243

FAQ

  • What is HLX43 being studied for? HLX43 is being studied in advanced non-small cell lung cancer (NSCLC). The trial is looking at whether it can help people with this advanced cancer.
  • Who may take part in the HLX43 trial? The trial is for people with advanced NSCLC. The source data does not give more detailed entry rules, so exact eligibility would depend on the study screening process.
  • What phase is the HLX43 trial? The listed study is a Phase 2 trial. Phase 2 studies usually look more closely at whether a treatment works and continue to collect safety information.
  • What is the main result the trial is measuring? The main result is objective response rate, often called ORR. This means the study checks how many people have a measurable improvement in their cancer on scans, using standard review rules.
  • How many people are planned for the HLX43 study? The trial plans to enroll 243 people. This gives the study enough participants to better assess the treatment effect in advanced NSCLC.

Ongoing Clinical Trials on HLX43

  • A study to evaluate the safety and effectiveness of HLX43 in patients with advanced non-small cell lung cancer

    Recruiting

    2 1 1
    Investigated drugs:
    France Italy Poland Romania Spain

Glossary

  • Advanced non-small cell lung cancer (NSCLC): A type of lung cancer that has spread or is at a later stage. It is the condition being studied in the HLX43 trial.
  • Clinical trial: A research study in people that tests whether a treatment is safe and effective.
  • Interventional study: A study where participants receive a treatment or procedure so researchers can measure its effects.
  • Phase 2: A middle stage of clinical testing that looks more closely at whether a treatment works and continues to monitor safety.
  • Objective response rate (ORR): The percentage of people whose cancer gets smaller or disappears for a time during treatment.
  • Blinded Independent Central Review (BICR): A review of scan results done by independent experts who do not know which treatment a person received, to make the results more fair.
  • RECIST v1.1: A standard set of rules used to measure changes in tumor size on scans.
  • Authorised: The study has been approved to start or continue by the relevant authority.
  • Enrollment: The number of people planned to join the study.
  • Interventional: A type of study where the researchers give a treatment and then observe what happens.

References