E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Advanced (stage IIIb and IV) non small cell lung cancer |
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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 |
The primary objective is the identification of differentially expressed genes that are predictive for benefit of Tarceva treatment.
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are to assess alterations in the EGFR signalling pathways with respect to benefit from treatment.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
-Histologically / cytologically documented advanced (Stage IIIB and IV) NSCLC where tumour tissue is accessible to biopsy via bronchoscopy. -Measurable disease according to RECIST criteria. -Failure of at least one prior regimen of standard chemotherapy or patients who are deemed unsuitable for chemotherapy in the investigators opinion or who are unwilling to undergo chemotherapy. -ECOG performance status of 0 - 2. -Life expectancy of at least 12 weeks. -At least 4 weeks since any previous surgery or radiotherapy. -Granulocyte count > 1,500/mm3 and platelet count > 100,000/mm3; Haemoglobin > or = 9.0 g/dL. - SGOT (AST) and SGPT (ALT) < 2,5 x ULN in the absence of liver metastases or up to 5 x ULN in case of liver metastases. -Alkaline phosphatase (ALP) < 2,5 x ULN. If alkaline phosphatase is > or = 2.5 x ULN, SGOT (AST) and SGPT (ALT) must be < 1.5 x ULN. -If alkaline phosphatase is > or = 2.5 x ULN in the presence of liver metastases, SGOT and SGPT must be < 5 x ULN. -Serum creatinine < 1.5 ULN or creatinine clearance > 60 ml/min. -Normal serum calcium. -Patient must be willing and able to undergo a bronchoscopy with biopsies according to the institute’s own guidelines and requirements for such procedures. -Coagulation parameters (PTT, INR) must be within normal range. -Platelet aggregation inhibitors must discontinued within an appropriate time period before bronchoscopy. -Male and female patients with reproductive potential must use reliable means of contraceptive
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E.4 | Principal exclusion criteria |
-Any disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding likely to affect the evaluation of the study or place the patient at risk whilst on Tarceva treatment or puts the patient at incalculable risk during biopsy. -Any other malignancies within the last 5 years before study start (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer). -Clinical evidence of brain metastasis, or 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 without evidence of stable disease for at least 2 months will also cause patients to be excluded. -Previous treatment with any therapy which acts on the EGFR axis. -Any known significant ophthalmologic abnormalities of the surface of the eye. -Patients using coumadin or warfarin.
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E.5 End points |
E.5.1 | Primary end point(s) |
Gene expression profiles in tumour tissue and normal cells. Gene mutation analysis for EGFR and other molecules involved in EGFR signal transduction |
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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 | Information not present in EudraCT |
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) | 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 | 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) | 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 | Yes |
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 |
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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
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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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |