NCT06062823

Study of EGFR TKI in Patients With Advanced NSCLC Harbouring EGFR Mutations

An Open-label Phase II Study of EGFR TKI in Patients With Advanced NSCLC Harbouring EGFR Mutations Categorized According to Structural Based Classification

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: National University Hospital, Singapore · Academic / Other
• Sex: All
• Age: 21 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to explore the efficacy of afatinib in NSCLC harbouring EGFR PACC mutation subtype. The main question it aims to answer is: Afatinib is active in patients with advanced NSCLC harbouring EGFR PACC mutation subtype. Participants will undergo screening, follow by treatment if eligible for study participation and then enter follow up phase after study medication has stopped. Patients will take afatinib 40mg daily continuously, until the development of progressive disease or meeting discontinuation criteria. A treatment cycle is defined as 28 days.

Detailed description

This is a multi-center, open-label, phase II study of patients with stage IIIb-IV NSCLC harbouring EGFR PACC mutations. Before taking the study drug, patients will need to undergo baseline assessments to ensure that they are eligible for the study. Then they will enter treatment period, where afatinib 40mg will be administered daily continuously, until the development of progressive disease or meeting discontinuation criteria. A discontinuation visit will be performed if patients stopped study drug for any reason. Thereafter, patients will be placed on Follow Up visit. Clinical assessment, routine blood tests and routine imaging: Physical examinations, imaging, and blood tests will be performed during baseline assessment, on the first day of each treatment cycle, after patients have completed the study and when clinically required by the treating physician. Patients will need to visit the doctor's office approximately 1-2 times every 4 weeks when they are receiving active treatment during the course of the study. More frequent visits may be needed as clinically indicated by the treating physician. Treatment procedure: Afatinib will be taken once a day at approximately the same time each day initially starting at a dose of 40mg. Afatinib must be taken on an empty stomach (at least one hour before or at least two hours after a meal). Research Blood samples: Blood samples for research will be taken at baseline, before starting cycle 3 and at the time of cancer progression. The estimated total volume of research blood that will be drawn is 10mL (2-3 teaspoons) each time for a total of 30mL.

Conditions

• NSCLC

Interventions

Type	Name	Description
DRUG	Afatinib 40 MG	Afatinib 40mg administered orally daily.

Timeline

• Start date: 2024-03-25
• Primary completion: 2026-10-01
• Completion: 2026-12-01
• First posted: 2023-10-02
• Last updated: 2025-07-24

Locations

1 site across 1 country: Singapore