E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Non small cell lung cancer |
|
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 |
|
E.2.2 | Secondary objectives of the trial |
Time to Progression Overall Survival Safety |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Signed written informed consent Male or female ≥18 years of age Cito-histological diagnosis of NSCLC, stage IV Performance Status = 0 or 1 Measurable disease on CT scan - RECIST criteria White blood count ≥ 3 x 109/L, Neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, and hemoglobin ≥ 9 g/dL Bilirubin level either normal or ≤1.5 x ULN ASAT and ALAT ≤ 2.5 x ULN (or 5 x ULN in case of liver metastases) Alkaline phosphatase ≤ 2,5 x ULN or ≤ 5 x ULN in case of bone metastases Creatinine clearance ≥ 50 ml/min Negative pregnancy test within one week before treatment start, if applicable Life expectancy of ≥ 3 months Availability of tumor sample (or able and willing to provide tumor sample) for EGFR assessment Effective contraception for both male and female patients if the risk of conception exists |
|
E.4 | Principal exclusion criteria |
Documented or symptomatic brain metastases Previous chemotherapy for NSCLC including adjuvant chemotherapy Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol Any investigational agent(s) within 4 weeks prior to entry Major surgery within 4 weeks prior to study entry Prior chest irradiation within 12 weeks prior to study entry (palliative radiation of bone lesions is allowed) Superior vena cava syndrome contra-indicating hydratation Previous exposure to EGF, monoclonal antibodies, signal transduction inhibitors or EGFR targeting therapy Myocardial infraction within 6 months prior to study entry, uncontrolled congestive heart failure; or any current grade 3 or 4 cardio-vascular disorder despite treatment Known allergic / hypersensitivity reaction to any of the components of study treatments Known drug abuse/ alcohol abuse Legal incapacity or limited legal capacity Symptomatic peripheral neuropathy (NCI-CTC) ≥ 2 and/or ototoxicity grade ≥ 2 , except if due to trauma or mechanical impairment due to tumor mass Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent Pregnancy or breastfeeding Any previous or concurrent malignancy other than nonmelanoma skin cancer, or carcinoma in situ of the cervix. (Patients with a previous malignancy but without evidence of disease for > 5 years will be allowed to enter the trial) |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Response of the tumor to the therapy assessed based on diagnostic imaging and classified according to the RECIST criteria |
|
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 | No |
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 | Information not present in EudraCT |
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) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
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 | No |
E.8.1.1 | Randomised | No |
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 | No |
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 | No |
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.8.5 | 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 | Information not present in EudraCT |
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
| |
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 | 7 |
E.8.9.1 | In the Member State concerned days | |