Gilotrif (Afatinib) in Advanced Non-Small Cell Lung Cancer Patients Pre-treated With Erlotinib or Gefitinib

An Open Label Compassionate Use Programme of Gilotrif (Afatinib) in Advanced Non-Small Cell Lung Cancer Patients Pre-treated With Erlotinib or Gefitinib

The program will provide early access to the investigational drug gilotrif in patients with advanced non-small cell lung cancer who have failed at least 6 months on erlotinib or gefitinib.

The Compassionate Use Programme will also provide additional safety information on gilotrif use.

Study Overview

• Status: Completed
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Gilotrif

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients with pathologically confirmed diagnosis of adenocarcinoma of the lung Stage IV with progressive disease following at least one line of platinum-based cytotoxic chemotherapy
2. Patients progressing after clinical benefit on erlotinib or gefitinib: clinical benefit is defined as stable disease for at least 6 months, or a complete or partial response, or the presence of an activating mutation of the epidermal growth factor (EGF) receptor family.
3. No further treatment option is available.
4. Male and female patients age ≥18 years.
5. Written informed consent that is consistent with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) guidelines and local law.

Exclusion Criteria:

1. Significant or recent acute gastrointestinal disorders with diarrhoea as a major symptom.
2. Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator, would compromise patient safety.
3. History of cardiac disease that is clinically significant, as judged by the investigator or uncontrolled cardiac disease (including congestive heart failure, angina, myocardial infarction, arrhythmia, including New York Heart Association (NYHA) functional classification of 3).
4. Aspartate amino transferase (AST) or alanine amino transferase (ALT) ≥ three times the upper limit of normal (if related to liver metastases ≥ five times the upper limit of normal).
5. Bilirubin ≥1.5 mg/dl
6. Serum creatinine ≥ 1.5 times of the upper normal limit or calculated/measured creatine clearance ≤ 45ml/min
7. Women of child-bearing potential or men who are able to father a child unwilling to use a medically acceptable method of contraception during the treatment.
8. Pregnancy or breast feeding.
9. Pre-existing Interstitial Lung Disease (ILD).
10. Patients suitable to be included into afatinib clinical trials

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: afatinib	Drug: Gilotrif; 50 mg with an option to reduce the dose to 40mg or 30 mg once a day Continuous daily dosing, one course consists of 28 days. Patients are eligible for repeated treatment courses in the absence of disease progression and undue toxicity.; Other Names: Afatinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
response rate	6 months

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: October 22, 2013
• First Submitted That Met QC Criteria: April 19, 2016
• First Posted (Estimate): April 22, 2016

Study Record Updates

• Last Update Posted (Actual): March 19, 2021
• Last Update Submitted That Met QC Criteria: March 18, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Afatinib
• Other Study ID Numbers: 2011-09-011