E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Non-small cell lung cancer locally advanced |
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MedDRA Classification |
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 |
Phase 1: To assess the safety of Cetuximab added to concurrent CRT
Phase 2: To assess the activity of combined regimen of Cetuximab with concurrent CRT
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E.2.2 | Secondary objectives of the trial |
Phase 1: Chronic toxicity
Phase 2: To assess the efficacy of combined treatment of low-dose Cisplatin and Cetuximab with radiotherapy in locally advanced NSCLC
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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 |
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E.3 | Principal inclusion criteria |
1. ≥18 years of age 2. Histologically or cytologically confirmed diagnosis of NSCLC 3. Stage II/III non-operable disease , without malignant pleural effusion 4. Presence of at least one measurable target lesion 5. Acceptable pulmonary function as defined by a Fev1 of ≥30% and a DLCO of ≥40% of predicted 6. Life expectancy of at least 6 months 7. WHO performance 0-1 8. Adequate hematological, renal and hepatic functions a. absolute neutrophil count > 2 x 109/l b. platelet count > 100 x 109/l c. total bilirubin < 2 x UNL d. ASAT/ALAT < ≤ 3 x UNL e. alkaline phosphatase < 5 x UNL f. creatinine < 130mol/l or creatinine clearance > 50ml/min; measured or calculated g. Urine dipstick for proteinuria < 1+. If urine dipstick is ≥ 1, 24 hour urine must demonstrate < 500 mg of protein in 24 hours. 9. No pre-existing sensory neurotoxicity grade 2 (CTC) 10. Patients of reproductive potential must agree to practice an effective medically approved contraceptive method during the trial and 3 months afterwards 11. Expected risk of radiation-induced pulmonary toxicity is not high: a. V20 ≤ 36% / MLD ≤ 20Gy (<20% radiation pneumonitis) 12. Signed written informed consent
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E.4 | Principal exclusion criteria |
1. Concurrent active malignancy other than localized, nonmelanoma skin cancer or carcinoma-in-situ of the cervix (unless definitive treatment was completed 3 years or more before study entry and the patient had remained disease free); 2. Prior: a. Ipsilateral radiotherapy to the chest; b. Chemotherapy within the last 5 years; c. Immunotherapy or treatment with murine monoclonal antibodies, Cetuximab, or other EGFR inhibitors. 3. Pregnant or breast-feeding patients 4. WHO performance score > 2 5. Other serious diseases, such as heart failure, angina pectoris, myocardial infarction within the last 6 months, uncontrolled hypertension 6. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before registration in the trial. 7. Participation in other trial with investigational drug or treatment modality.
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E.5 End points |
E.5.1 | Primary end point(s) |
Phase I: Adverse events (dose-limiting toxicities defined in Paragraph 9.4) Phase 2: Objective tumour response (According to RECIST)
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
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 | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
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E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
fase I open and fase II randomised |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
chemoradiation without cetuximab |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |