| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Locally advanced or metastatic NSCLC with non squamous histological type |
|
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 12.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10061873 |
| E.1.2 | Term | Non-small cell lung cancer |
|
| 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 |
| To evaluate the efficacy of both regimens in terms of Disease Control rate. |
|
| E.2.2 | Secondary objectives of the trial |
- To evaluate the response rate in both arms.
- To evaluate the duration of the disease control, the duration of response, the time to treatment failure (TTF) in both arms.
- To evaluate the progression free survival and overall survival in both arms.
- To evaluate the tolerance in both arms.
- To assess QOL using LCSS in both arms.
- To assess Satisfaction Questionnaire in both arms.
- To assess Pharmaco-economical aspect in both arms. |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
- Chemo-naive patients from 18 years to 75 years.
- Performance status KPS > 80.
- Non-squamous histologically or cytologically (fine needle aspiration is acceptable) proven non-small cell lung cancer.
- Stage IIIB (with supra-clavicular nodal metastases or pleural effusion), stage IV or relapsing (locally or distant) after a local treatment. Patients not suitable for loco-regional treatment.
- Life expectancy more than 12 weeks.
 Adequate bone marrow, hepatic and renal functions:
o Neutrophils > 2.0x109/l , platelets > 100x109/l, Haemoglobin > 11 g/dl or 6.8 mmol/l.
o Total bilirubin  1.5xULN, Transaminases < 2.5xULN, Alkaline Phosphatases < 5xULN.
o Creatinine < ULN (if limit value, creatinine clearance > 60 ml/min).
 Prior therapy:
o Surgery: patients may have had previous surgery for NSCLC.
o Chemotherapy: patients must not have had systemic chemotherapy or immunotherapy.
o Radiation therapy: patient is eligible if presence of target lesions outside the irradiated area.
 Presence of at least one measurable indicator lesion (RECIST criteria. Version 1.1) which has not been previously irradiated. Measurable lesions (measured in at least one dimension) (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan.
Physical examination and ultrasound will not be considered as objective tumour assessments.
- The patient must give written (personally signed and dated) informed consent before completing any study-related procedure.
- Absence of any psychological, familial, sociological or geographical conditions potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before registration in the trial.
- Women of childbearing potential must be using a medically accepted method of contraception (i.e. oral contraceptives, intrauterine devices) to avoid pregnancy during the 2 months preceding the start of study treatment, throughout the study period and for up to 3 months after the last dose of study treatment in such a manner that the risk of pregnancy is minimised. Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the start of study treatment.
 Fertile men must be using an effective method of birth control if their partners are women of childbearing potential during study period and up to 3 months following the last dose of treatment.
 The patient must have access to social insurance according to local regulations. |
|
| E.4 | Principal exclusion criteria |
Patients with at least one of the following criteria will not be included:
 A female is not eligible to enter the study if:
 Pregnant or lactating.
 With positive pregnancy test at inclusion.
 Known hypersensitivity to the study drug(s) or to drugs with similar chemical structures.
 Treatment with any investigational drug within the 30 days prior to randomisation.
 Any important factor likely to modify drug absorption, e.g. surgery of GIT significant malabsorption syndrome or disease affecting the gastro-intestinal tract function.
 Patients with a local relapse, which is liable to be treated by radiation therapy.
 Previous radiotherapy in the only site used to assess response.
 Radiotherapy within the previous 4 weeks.
 Clinically relevant cardiovascular, hepatic, neurological or other systemic disease making implementation of the protocol difficult.
o Active central nervous system disorder, brain metastasis or leptomeningeal involvement.
o Symptomatic neuropathy (sensory) > grade 1 according to the NCI Common Toxicity Criteria (NCI CTC version 2).
o Concomitant/uncontrolled medical disorder (cardiac failure or myocardial infarction within the previous 3 months, uncontrolled hypertension or arrhythmia, uncontrolled hypercalcaemia, active infection requiring i.v. antibiotics within 2 weeks before the beginning of treatment).
o Weight loss > 10% within the previous 3 months.
o Superior vena cava syndrome.
o Long term oxygen therapy.
o Pre-existing symptomatic pleural effusion requiring tapping.
o Ascites or pericardial effusion.
 History of another malignancy within the past five years except basal cell carcinoma of the skin or carcinoma in situ of the cervix. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| The main endpoint of this study is the disease control rate defined as the sum of complete response, partial response and stable disease rates. |
|
| 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 | 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) | 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 | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | Yes |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | Yes |
| 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) | Yes |
| 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.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 28 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
| 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
|
| La conclusione dello studio sara` 30 giorni dopo l`osservazione dell`ultima progressione di malattia. Le informazioni relative alla sopravvivenza saranno raccolte con cadenza trimestrale fino al decesso del paziente. |
|
| 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 | 9 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial years | 2 |
| E.8.9.2 | In all countries concerned by the trial months | 9 |
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