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Tyrosine Kinase Inhibitors in DyplAsia of Lung Epithelium

Phase 2
18 Years
80 Years
Open (Enrolling)
Lung Cancer, Head and Neck Cancer

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Trial Information

Tyrosine Kinase Inhibitors in DyplAsia of Lung Epithelium

Inclusion Criteria

- Age 18 years or above

- Resected NSCLC or Squamous cell Head & Neck cancer treated curatively

- All treatment, including any adjuvant treatment with radiotherapy and/or chemotherapy
completed at least 3 months prior to study entry

- ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1

- Suitable for flexible bronchoscopy

- Able to give signed informed consent

- Adequate haematological, kidney and liver function:

- Serum alanine transaminase (ALT) ≤2.5 x upper limit of normal (ULN)

- Total serum bilirubin ≤1.5 x ULN

- Absolute neutrophil count (ANC) ≥1500/μL

- Platelets ≥100,000/μL

- Haemoglobin ≥9.0 g/dL

- Sufficient renal function to allow administration of contrast medium (in line
with Royal College of Radiologists guidelines).

In addition, the following inclusion criteria must be met during the screening period in
order to confirm eligibility for the study treatment

- No evidence of malignant disease activity on screening

- High grade dysplasia on autofluorescence bronchoscopy analysis

- No evidence of pulmonary fibrosis or interstitial lung disease on screening CT

Exclusion Criteria:

- Diagnosis of any second malignancy within the 5 years from date of enrolment, except
basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma of the cervix
uteri that has been adequately treated with no evidence of recurrent disease for 12

- Evidence of severe or uncontrolled systemic disease or psychiatric disorder that
would interfere with the patient's safety

- Known severe hypersensitivity to Gefitinib or any of the excipients of the product

- Past medical history of interstitial lung disease, drug-induced interstitial disease,
radiation pneumonitis which required steroid treatment or any evidence of clinically
active interstitial lung disease

- Pre-existing idiopathic pulmonary fibrosis

- History of allergy to contrast medium

- Insufficient lung function as determined by either clinical examination or an
arterial oxygen tension (PaO2) of < 9.3kpa

- Inability to swallow oral medications

- Presence of active inflammatory bowel disease, partial or complete bowel obstruction
or chronic diarrhoea or any condition which would interfere with absorption of an
oral drug.

- Past medical history of keratitis

- Past medical history of Sjogren's syndrome

- Pregnant or breast-feeding

- Male and female patients (of childbearing age) not using, or not willing to use,
protocol mandated contraception

- Prior EGFR inhibitor use.

- Concurrent medication with known potent CYP3A4 inhibitors and inducers and/or dosing
within 7 days of date of enrolment (e.g.. ketoconazole, rifampin, phenytoin,
carbamazepine, barbiturates or herbal preparations containing St John's
wort/Hypericum perforatum etc.) or use of other concomitant medication incompatible
with study drug (see SmPC)

- Current treatment on another therapeutic clinical trial or previous investigational
agent in the last 12 weeks (supportive care trials or non-treatment trials are

- Previous enrolment or treatment in the present study.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of high grade dysplasia of the bronchial epithelium in patients at high risk of lung dysplasia

Outcome Description:

Patients will have white/blue light bronchoscopy with biopsy of identified lesions. The incidence of high grade lung epithelial dysplasia will be recorded.

Outcome Time Frame:

during the screening broncoscopy - carried out within the first month post consent

Safety Issue:


Principal Investigator

Tim Eisen, Professor

Investigator Role:

Study Chair

Investigator Affiliation:

Papworth Hospital NHS Trust


United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

December 2011

Completion Date:

December 2014

Related Keywords:

  • Lung Cancer
  • Head and Neck Cancer
  • Head and Neck Neoplasms
  • Lung Neoplasms