E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
High grade dysplasia of the bronchoepithelium |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10057004 |
E.1.2 | Term | Bronchial dysplasia |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The main purpose of this study is to identify a group of patients who have a high incidence of abnormal, pre-cancerous areas in the lining of their airways which put them at high risk of developing lung cancer. |
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E.2.2 | Secondary objectives of the trial |
The study also aims to identify whether high risk patients find autofluorescence bronchoscopy to be an acceptable test for the identification and monitoring of the pre-cancerous changes in the airways, to assess the response of pre-cancerous areas to the drug Gefitinib and to collect information about the level and exact type of marker proteins which may be abnormal in pre-cancerous areas in the lungs. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Sample collection sub-study (included in main study protocol: All patients that consent to take place in the main aspects of the TIDAL study will also have the opportunity of participating in a tumour sample collection sub-study. Consent for this will be obtained on the main study consent form, and further information will be provided in the Patient Information Sheet. Refusal to consent to tumour block collection will not be a reason to exclude patients from participating in the rest of the study. We would like to collect paraffin-embedded tumour tissue blocks (or frozen tumour blocks, where available) from patients on the TIDAL study to be used in future research. These samples may be used for future biomarker discovery and validation studies, as they can be used to correlate biological markers with clinical outcomes including, response to chemotherapy. Blocks from tissue taken at initial surgery and stored in the pathology department diagnostic archives as well as excess tissue removed at staging, and during follow-up bronchoscopies will be requested retrospectively for patients who enter this sub-study. |
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E.3 | Principal 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 : o Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤2.5 x upper limit of normal (ULN) o Total serum bilirubin ≤1.5 x ULN o Absolute neutrophil count (ANC) ≥1500/μL o Platelets ≥100,000/μL o Haemoglobin ≥9.0 g/dL o Serum creatinine ≤2.0 x ULN 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 |
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E.4 | Principal 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 months. 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 evidenced by CT scan at baseline 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. 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 allowed) Previous enrolment or treatment in the present study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Incidence of high grade dysplasia within the target population |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The trial is deemed to have ended 12 months after the last patient started the study treatment. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |