RecruitingPhase 2NCT06192849

To Assess the Efficacy and Safety of Furmonertinib in Patients With Epidermal Growth Factor Receptor 20ins Mutation Positive Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy

A Phase II, Prospective, Multi-centre, Study to Assess the Efficacy and Safety of Furmonertinib in Patients With Epidermal Growth Factor Receptor 20ins Mutation Positive Stage IB-IIIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection With or Without Adjuvant Chemotherapy


Sponsor

Juan LI, MD

Enrollment

20 participants

Start Date

Dec 31, 2023

Study Type

INTERVENTIONAL

Summary

This is a phase II, prospective, multi-centre study. To assess the efficacy and safety of furmonertinib in patients with epidermal growth factor receptor 20ins mutation positive stage IB-IIIA Non-small Cell Lung Carcinoma, following complete tumour resection with or without adjuvant chemotherapy. The study plans to enroll 20 subjects, treating with furmonertinib 160mg/d, until disease recurrence, death or intolerability. The maximum duration of treatment is three years. The primary endpoint is DFS. The secondary endpoint include DFS rate , OS and the change of HRQoL. In addition, the peripheral blood ctDNA will be collected and analyzed in this study


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing furmonertinib, a targeted oral drug, as a treatment after surgery for early-to-intermediate stage non-small cell lung cancer in patients whose tumor has a specific genetic change (EGFR exon 20 insertion mutation). **You may be eligible if...** - You are 18 or older - You had complete surgical removal of your lung cancer (all cancer removed, clear margins) - Your tumor is confirmed to have an EGFR exon 20 insertion mutation - Your cancer was classified after surgery as stage IB, II, or IIIA - You have fully recovered from surgery and any adjuvant chemotherapy - Your general health is good (ECOG 0–1) **You may NOT be eligible if...** - You only had a small partial lung removal (wedge or segmentectomy — a full lobe must have been removed) - You received any prior cancer treatment other than adjuvant platinum-based chemotherapy - You are taking medications that strongly affect a liver enzyme called CYP3A4 - 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

This arm plans to enroll 20 subjects, treating with furmonertinib 160mg/d, until disease recurrence, death or intolerability. The maximum duration of treatment is three years.


Locations(1)

Sichuan cancer hospital

Chengdu, Sichuan, China

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NCT06192849