E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
advanced non-small cell lung cancer NSCLC after failure of standard first line chemoterapy |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10061873 |
E.1.2 | Term | Non-small cell lung cancer |
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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 compare the efficacy in terms of OS of erlotinib vs docetaxel given as second line therapy in patients with advanced NSCLC |
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E.2.2 | Secondary objectives of the trial |
To compare: - PFS - RR - Quality of life |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
 Age 18 years or older  Histological or cytological confirmation of NSCLC (may be from initial diagnosis of NSCLC or subsequent biopsy). Only patients with available tissue samples may be included in the study.  Absence of EGFR mutations  Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy  One prior chemotherapy regimens, at least one of which must have been platinum-based and taxanes free. Patients who initially presented with early stage disease but subsequently progressed or recurred are eligible if they received full dose platinum-based taxanes free adjuvant chemotherapy at full cytotoxic doses of platinum therapy as part of a chemotherapy/radiotherapy regimen. They will not be eligible if they have only received platinum at a radiosensitizing dosage (prior surgery and/or localized irradiation are allowed)  Measurable (uni-dimensional) disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria in a lesion not previously irradiated or non-measurable disease  World Health Organization performance status (WHO-PS) 0-2  Absolute Neutrophil Count (ANC) greater than 1.5 x 109/liter (L) and platelets greater than 100 x 109/L  Bilirubin level either normal or < 1.5 x ULN  AST (SGOT) and ALT (SGPT) £ 2.5 x ULN (£ 5 x ULN if liver metastasis are present)  Serum creatinine < 1.5 x ULN  Effective contraception for both, male and female patients if the risk of conception exists  Recovery from all acute toxicities of prior therapies  Provision of written informed consent to the to the analysis of biological markers  Provision of written informed consent to enter the appropriate part of the study |
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E.4 | Principal exclusion criteria |
 Prior therapy with an experimental agent whose primary mechanism of action is inhibition of EGFR or its associated tyrosine kinase  Prior docetaxel treatment for NSCLC  Newly diagnosed central nervous system (CNS) metastases that have not yet been treated with surgery and/or radiation. Pts with previously diagnosed and treated CNS metastases or spinal cord compression may be considered if they have evidence of clinically stable disease (SD) (no steroid therapy or steroid dose being tapered) for at least 28 days  Less than 14 days since completion of prior radiotherapy or persistence of any radiotherapy related toxicity  Any unresolved chronic toxicity from previous anticancer therapy that, in the opinion of the investigator, makes it inappropriate for the patient to be enrolled in the study  Known severe hypersensitivity to erlotinib or any of the excipients of this product  Known hypersensitivity to docetaxel, polysorbate 80 or other drugs formulated with polysorbate 80, or any of the excipients of docetaxel  Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ  Unable to swallow tablets  Any evidence of clinically active interstitial lung disease (ILD) (patients with chronic, stable, radiographic changes who are asymptomatic or patients with uncomplicated progressive lymphangitic carcinomatosis need not be excluded)  As judged by the investigator, any evidence of severe or uncontrolled systemic disease (eg, unstable or uncompensated respiratory, cardiac, hepatic or renal disease)  Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study |
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E.5 End points |
E.5.1 | Primary end point(s) |
 PFS is defined as the time from the date of randomisation up to the date of first progression, second primary malignancy or death from any cause, whichever comes first. Subjects who have not progressed or died while on study will be censored at the last disease assessment date. 
OS is defined as the time from the date of randomisation to the date of death from any cause. Subjects who were not reported as having died at the time of the analysis will be censored at the date they were last known to be alive. 
Toxicity, graded according to the NCI-CTAE version 3.0 
Frequency and nature of serious adverse reactions 
Premature withdrawals |
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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 | No |
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 | Information not present in EudraCT |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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.8.5 | 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
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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 | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |