E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
unresectable, advanced and/or metastatic non-small cell lung cancer |
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E.1.1.1 | Medical condition in easily understood language |
unresectable, advanced and/or metastatic non-small cell lung cancer |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
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 |
To evaluate time to disease progression (TTP) and pathological response rate (CR, PR) according to RECIST criteria
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E.2.2 | Secondary objectives of the trial |
- To evaluate median and overall survival (OS) - To evaluate safety profile in first line setting of Tarceva (erlotinib) 150mg po daily plus Gemcitabine 1000mg/m² iv D1, D8, D15 until disease progresion (PD), unacceptable toxicity, withdrawal due to any reason or death.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Histological or cytological documented diagnosis of advanced and/or metastatic (stage IIIB/ IV) chemotherapy-naive, unresectable, non-small cell lung cancer (NSCLC) • Patients must have evidence of disease with at least one measurable disease evaluate on RECIST criteria • 18 years of age or older • ECOG performance status >/= 2 • Life expectancy of at least 12 weeks. • Patients with advanced stage IIIB /IV NSCLC who did not received any course of standard systemic chemotherapy or radiation therapy or immunotherapy. • Patients who, in the opinion of the investigator, are not suitable for surgery.Patients must have recovered (CTC < 1) from acute toxicities of any previous therapy. • Patients must have prescription for Gemcitabine 1000mg/m² iv D1, D8, D15 (q28) at the time of study enrollment. • Granulocyte count > 1.5 x 109/L and platelet count > 100 x 109/L • Serum bilirubin must be < 1.5 upper limit of normal (ULN). • AST and/or ALT < 2 x ULN (or < 5 x ULN if clearly attributable to liver metastasis • Serum creatinine < 1.5 ULN or creatinine clearance > 60 ml/min • Able to comply with study and follow-up procedures • For all females of childbearing potential a negative pregnancy test must be obtained within 72 hours before starting therapy. • Patients with reproductive potential must use effective contraception • Written (signed) Informed Consent to participate in the study
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E.4 | Principal exclusion criteria |
• Any active, non-controlled systemic disease (including infection, grade 4 hypertension, unstable angina, congestive heart failure, hepatic, renal or metabolic disease). • Prior therapy with systemic anti-tumour therapy with HER1/EGFR inhibitors (as small molecule or monoclonal antibody therapy). • Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer). • Patients are excluded if they have brain metastasis or spinal cord compression that is newly diagnosed and/or has not yet been definitively treated with surgery and/or radiation; previously diagnosed and treated CNS metastases or spinal cord compression with evidence of stable disease (clinically stable imaging) for at least 2 months is permitted. • Any significant ophthalmologic abnormality, especially severe dry eye syndrome, keratoconjunctivitis sicca, Sjögren syndrome, severe exposure keratitis or any other disorder likely to increase the risk of corneal epithelial lesions. The use of contact lenses is not recommended during the study. The decision to continue to wear contact lenses should be discussed with the patient’s treating Oncologist and the ophthalmologist. • Patients who cannot take oral medication, who require intravenous alimentation, have had prior surgical procedures affecting absorption, or have active peptic ulcer disease. • Nursing mothers.
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E.5 End points |
E.5.1 | Primary end point(s) |
• To evaluate time to disease progression (TTP) and • Response rate (CR, PR) according to RECIST criteria
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
• To evaluate median overall survival (OS) • To evaluate safety profile in first line setting of Tarceva (erlotinib) 150 mg po daily plus Gemcitabine 1000mg/m² iv D1, D8, D15 for 6 cycles or until disease progression (PD), unacceptable toxicity, withdrawal due to any reason or death.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | 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 | No |
E.8.1.1 | Randomised | No |
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 | 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.8.2.4 | Number of treatment arms in the trial | 1 |
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.8.5 | 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 | No |
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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Treatment will continue until disease progression (PD), unacceptable toxicity , withdrawal due to any reason or death. The study will be terminated after every living patient has been followed for at least 12 months or has withdrawn their consent to continue in the study. The analysis will take place at this time. |
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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 | |
E.8.9.1 | In the Member State concerned months | 20 |
E.8.9.1 | In the Member State concerned days | |