RecruitingPhase 2NCT06394674

High-dose Furmonertinib in the Treatment in Patients With Advanced, Metastatic NSCLC With Progressed After First- or Second-line Treatment With Osimertinib

A Prospective, Randomized, Phase ll Clinical Trial of Single-agent Treatment With Different Doses of Sulfamethoxazole Furmonertinib in Patients With Advanced, Metastatic Lung Adenocarcinoma Who Have Progressed After First- or Second-line Treatment With EGFR-TKl Osimertinib


Sponsor

Changhai Hospital

Enrollment

84 participants

Start Date

May 1, 2024

Study Type

INTERVENTIONAL

Summary

This is a prospective, randomised, uncontrolled phase II clinical trial planned to include 84 subjects with metastatic lung adenocarcinoma that had progressed after first- or second-line treatment with Osmertinib, who were randomly assigned to trial group 1 and trial group 2, and were given Furmonertinib 160 mg and 240 mg once/day, orally, respectively, with efficacy evaluated every 6 weeks until disease progression, intolerable toxic side effects, or Subjects voluntarily withdrew informed consent.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a higher dose of furmonertinib — a targeted therapy that crosses into the brain — works better than the standard dose for people with advanced non-small cell lung cancer (NSCLC) that has an EGFR mutation and has spread to the brain. **You may be eligible if...** - You have advanced or metastatic non-small cell lung cancer - Your cancer has an EGFR mutation (a specific genetic change) - Your cancer has spread to the brain - You have not previously been treated with an EGFR inhibitor, OR you have progressed on a first or second-generation EGFR inhibitor **You may NOT be eligible if...** - You have previously received a third-generation EGFR inhibitor (like osimertinib) - Your brain metastases require immediate surgery or high-dose steroids - You have serious heart problems (QT prolongation or weak heart function) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFurmonertinib

Drug: Furmonertinib


Locations(1)

Changhai Hospital

Shanghai, China

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NCT06394674