Europas førende søgning efter kliniske forsøg

HLX43

Clinical trials are studying HLX43 in people with advanced non-small cell lung cancer (NSCLC). The main goal is to see how well it works and how safe it is. The current study is in Phase 2 and includes adults with advanced NSCLC.

Table of contents

Trial overview

The available trial is a clinical study of HLX43 in people with advanced non-small cell lung cancer (NSCLC).[1] The study is designed to look at both safety and effectiveness in this cancer setting.[1]

Who is being studied

The trial targets people with advanced NSCLC, which is a later stage of lung cancer.[1] The source does not list more detailed entry rules, so the full participation criteria are not available here.[1]

What the study measures

The main result being measured is objective response rate (ORR).[1] ORR shows how many patients have a clear tumor response during the study, and the response is checked by Blinded Independent Central Review (BICR) using RECIST v1.1 rules.[1]

Study phase and design

The study is a Phase 2 trial.[1] Phase 2 studies usually focus on learning more about whether a treatment helps patients while continuing to watch safety.[1] This trial is also described as interventional, which means participants receive the study treatment and outcomes are then measured.[1]

HLX43 is given as a drug for injection by intravenous administration, meaning it is delivered through a vein.[1]

Trial status and size

The study status is Authorised, so it has been approved to run.[1] The planned enrollment is 243 people.[1]

What the results will mean

If the study shows a meaningful response rate, it may support further research on HLX43 in advanced NSCLC.[1] The trial data provided here do not include final results, so the current focus is on testing how well the treatment performs in this patient group.[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 in the trials? HLX43 is being studied for 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 study is for people with advanced NSCLC. The trial data do not give more detailed entry rules in the source provided.
  • What phase is the HLX43 study in? The listed trial is in Phase 2. This means the study is focused on learning more about how well the treatment works and continuing to assess safety.
  • What is the main result the trial is measuring? The main result is objective response rate, or ORR. This means the researchers check how many patients have a clear reduction in their cancer on scans, using standard review rules.
  • How many people are planned for the HLX43 study? The trial plans to include 243 people. This number helps researchers collect enough data to understand the treatment better.

Igangværende kliniske forsøg for HLX43

  • Undersøgelse af effekten og sikkerheden af HLX43 til behandling af patienter med fremskreden ikke-småcellet lungekræft

    Rekrutterer

    1 1
    Undersøgte lægemidler:
    Frankrig Italien Polen Rumænien Spanien

Ordliste

  • 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 a medical treatment to see how well it works and how safe it is.
  • Interventional study: A study where researchers give a treatment or action to participants and then measure the results.
  • Phase 2: A stage of clinical research that looks more closely at whether a treatment works and continues safety checks.
  • Objective response rate (ORR): The share of patients whose cancer shrinks or disappears in a measurable way during the study.
  • Blinded Independent Central Review (BICR): An outside review by experts who assess scan results without knowing which treatment a patient received.
  • RECIST v1.1: A standard set of rules used to measure changes in tumors on scans in cancer studies.
  • Enrollment: The number of people planned to join a study.
  • Authorised: The study has been approved to run.
  • Intravenous administration: Giving a treatment through a vein, usually with a needle or line placed in the arm.

Referencer

  1. https://kliniske-forsoeg.dk/forsog/undersogelse-af-effekten-og-sikkerheden-af-hlx43-til-behandling-af-patienter-med-fremskreden-ikke-smacellet-lungekraeft/