Actively Recruiting
Study of EGFR TKI in Patients With Advanced NSCLC Harbouring EGFR Mutations
Led by National University Hospital, Singapore · Updated on 2025-07-24
35
Participants Needed
1
Research Sites
140 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of EGFR TKI in Patients With Advanced NSCLC Harbouring EGFR Mutations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histological or cytological confirmation of NSCLC
- No prior systemic therapy for advanced stage disease
- Presence of a PACC mutation detected in blood or tumor
- Measurable disease per RECIST 1.1 criteria
- Estimated life expectancy of at least 3 months
- ECOG performance status of 0 or 1
- Age 21 years or older
- Adequate organ and blood function meeting specific laboratory criteria
- Negative pregnancy test for females of childbearing potential within 14 days before starting study medication
- Agreement to use effective contraception during treatment and for 4 months after
- Signed informed consent
You will not qualify if you...
- Prior treatment with EGFR tyrosine kinase inhibitors
- Previous chemotherapy for stage IIIB/IV lung adenocarcinoma except if completed more than 12 months before progression
- Diagnosis of another primary cancer except certain treated cancers or relapse-free for at least 3 years
- Known leptomeningeal carcinomatosis
- Unstable spinal cord compression or brain metastases unless asymptomatic and off steroids for at least 2 weeks
- Symptomatic untreated spinal cord compression
- Significant uncontrolled cardiovascular disease within 6 months prior to enrollment
- Recent cerebrovascular accident or transient ischemic attack within 6 months
- Major surgery within 4 weeks before starting treatment
- Extensive recent radiotherapy to bone marrow
- Inability to swallow oral medications
- Severe gastrointestinal conditions affecting drug absorption
- History or presence of pulmonary interstitial disease or pneumonitis
- Active infection requiring intravenous antibiotics
- Known HIV or active hepatitis B or C infection or active tuberculosis
- Known allergy to afatinib or its components
- Pregnancy, planning pregnancy, or breastfeeding
- Lack of effective contraception use in reproductive potential patients
- Previous allogeneic bone marrow transplant
- Any condition compromising safety or interfering with treatment as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National University Hospital
Singapore, Singapore
Actively Recruiting
Research Team
K
Kenneth Sooi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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