An Open Label Compassionate Use Programme of afatinib in Advanced Non-Small Cell Lung Cancer Patients Pre-treated with Erlotinib or Gefitinib (LUX-lung CUP Belgium/Luxembourg)

Study Objective

To provide early access to and evaluate the safety and tolerability of BIBW 2992 in the treatment of patients with non-small cell lung cancer (adenocarcinoma) who have failed erlotinib or gefitinib treatment.
The aim of this Compassionate Use Program is to make, on an individual patient basis, Tomtovok® (afatinib) available to patients who suffer from advanced Non-Small Cell Lung Cancer and, in the opinion and the clinical judgment of the treating physician, would benefit from a treatment with the product that does not have a marketing authorization yet.
The disease for which the drug is requested is a chronic disease or severely affects patient’s health or is life-threatening and cannot be satisfactorily treated by the drugs currently marketed and approved for the treatment in this indication.

Participation conditions

The patients who will be eligible to participate in the Compassionate Use Program are the following:

1. Male and female patients age ≥18 years
2. Patients with pathologic confirmation of adenocarcinoma of the lung, Stage IIIB Stage IV1 (7th edition of the “TNM classification”)
3. Patients who have failed at least one line of cytotoxic chemotherapy and
4. Patients who have failed at least 12 weeks of treatment with erlotinib (Tarceva®) or gefitinib (Iressa®)
5. Patients who are ineligible to participate in another phase III trial with Tomtovok® (afatinib)
6. Patients with no other treatment options available

Patients should have been clearly and completely informed by the requesting physician and provided written consent, before the start of the treatment.
 

Centre Hospitalier de Luxembourg  (CHL) – Oncology