E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Locally advanced or metastatic 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 |
To compare ALIMTA plus cisplatin with GEMZAR plus cisplatin in terms of the overall survival of previously untreated patients with Stage IIIB and IV NSCLC. |
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E.2.2 | Secondary objectives of the trial |
Compare between treatment arm: Time-to-event efficacy variables, including:Progression-free survival, Time to progressive disease, Duration of response, Time to treatment failure Objective tumor response Quantitative and qualitative laboratory and nonlaboratory toxicities Risk/benefit (toxicities relative to survival) |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Histologic or cytologic diagnosis of NSCLC Stage IIIB or IV No prior systemic chemotherapy for lung cancer At least one unidimensionally measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST), longest diameter ,10 mm with spiral computed tomography (CT) scan, or ,20 mm with conventional techniques.Positron emission tomography (PET) scans and ultrasounds should not be used for lesion measurements. ECOG performance status of 0 or 1 At least 18 years of age Adequate organ function, including the following: Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) ³1.5 ´ 109/L, platelets ³100 ´ 109/L, and hemoglobin ³9 g/dL.Hepatic: bilirubin £1.5 times the upper limit of normal (´ ULN), alkaline phosphatase (AP), aspartate transaminase (AST), and alanine transaminase (ALT) £3.0 ´ ULN (AP, AST, and ALT £5 ´ ULN is acceptable if the liver has tumor involvement) Renal: calculated creatinine clearance (CrCl) ³45 mL/minute based on the standard Cockcroft and Gault formula (Cockcroft and Gault 1976). Prior radiation therapy allowed to <25% of the bone marrow. Prior radiation to the whole pelvis is not allowed.Prior radiotherapy must be completed at least 4 weeks before study enrolment. Patients must have recovered from the acute toxic effects of the treatment prior to study enrolment. Estimated life expectancy of > 12 weeks
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E.4 | Principal exclusion criteria |
Peripheral neuropathy of > CTC grade 1 Serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient’s ability to complete the study. Serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class III or IV. Second primary malignancy that is clinically detectable at the time of consideration for study enrollment. Documented brain metastatses unless the patient has completed successful local therapy for central nervous system metastases and has been off of corticosteroids for at least 4 weeks before enrollment. Brain imaging is required in symptomatic patients to rule out brain metastases, but is not required in asymptomatic patients. Presence of clinically detectable (by physical exam) third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry. Significant weight loss (that is > 10%) over the previous 6 weeks before study entry. Concurrent administration of any other antitumor therapy. Inability to interrupt aspirin or other non-steroidal anti-inflammatory agents for 5-day period (8-day period for long-actiong agents, such as piroxicam) Inability or unwillingness to take folic acid or vitamin B12. Inability to take corticosteroids |
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E.5 End points |
E.5.1 | Primary end point(s) |
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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) | 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 | 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) | 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 | 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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Final analysis will be performed after approximately 1190 deaths have occurred (that is, 30% censoring rate). After completion of the trial, data may continue to be collected on surviving patients. The post-lock data will eventually be combined with the locked database and stored in a data library separate from the locked database. |
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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 | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 6 |