RecruitingPhase 3NCT06674343

Furmonertinib 160mg as First-line Treatment in Locally Advanced or Metastatic NSCLC With EGFR Classical Mutations

The Efficacy and Safety of Furmonertinib 160mg as First-line Treatment in Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With EGFR Classical Mutations, a Prospective, Single-arm, Multicenter Clinical Study


Sponsor

Peking Union Medical College Hospital

Enrollment

144 participants

Start Date

Jul 15, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

To evaluate the efficacy, safety, recurrence site, recurrence pattern and resistance mechanism of 160mg furmonertinib as first-line therapy in advanced or metastatic non-small cell lung cancer (NSCLC) patients with EGFR classical mutations(19Del or L858R).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing furmonertinib (at a dose of 160 mg) as the first treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has specific EGFR gene mutations (exon 19 deletion or L858R). These mutations make lung cancer cells sensitive to EGFR-blocking drugs called third-generation TKIs. **You may be eligible if...** - You are 18 or older with confirmed advanced or metastatic lung cancer (adenocarcinoma type) - Your tumor has an EGFR mutation (exon 19 deletion or L858R) confirmed by local testing - You have not previously received any systemic cancer treatment for your advanced disease - You have at least one measurable tumor lesion on imaging **You may NOT be eligible if...** - You have previously received EGFR-targeting therapy or any other cancer treatment for this advanced disease - Your cancer has spread to the brain in an active, symptomatic way - Your heart function (particularly QTc interval) or organ function does not meet the required thresholds 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

Furmonertinib 160mg, once daily, orally. Other Names: AST2818


Locations(1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

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NCT06674343


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