E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Advanced Non Small Cell Lung Carcinoma |
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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 demonstrate in a prospective way a benefit in terms of overall survival and progression-free survival of Gefitinib (ZD1839, IressaTM) compared to placebo in patients with advanced non small cell lung cancer (NSCLC), who are not progressing on first line palliative induction chemotherapy. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
♦ Histologically and/or cytologically proven NSCLC. ♦ Patients with clinical stage IV or IIIB (with pleural fluid and/or supraclavicular nodes – provided not eligible for consolidation radiotherapy). ♦ Patients with brain metastases are eligible, provided the latter are asymptomatic after cranial irradiation. The latter should be ended for at least 4 weeks. ♦ WHO performance status 0-2 (cf. Appendix B) ♦ Age ≥ 18 years ♦ Absence of progression after a minimum of 2 and a maximum of 6 cycles of platinum containing palliative first line chemotherapy; confirmation of objective response is not mandatory. Last response evaluation should be not older than 3 weeks before randomisation. The criteria of response evaluation (WHO or RECIST) are left at the investigator’s discretion. ♦ Absence of grade 3/4 toxicity caused by prior chemotherapy (except alopecia) ♦ Absence of other malignant disease, unless in remission for at least 5 years. Patients with basal cell carcinoma of the skin or adequately treated superficial carcinoma of the cervix are eligible regardless of this interval. ♦ Patients of reproductive potential must agree to practice an effective contraceptive method. Women of childbearing potential must not be pregnant or lactating. ♦ Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before randomization in the trial ♦ Before patient randomization, written informed consent must be given according to ICH/GCP, and national/local regulations. Patients can only be randomized in this trial once. |
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E.4 | Principal exclusion criteria |
♦ Prior treatment with EGFR inhibitors ♦ History, signs or symptoms of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded). ♦ Concomitant use of the following drugs: phenytoin, carbamazepine, rifampicin, phenobarbital or St John's Wort |
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E.5 End points |
E.5.1 | Primary end point(s) |
To compare overall survival between adjuvant Gefitinib and placebo in patients not progressing on first line palliative chemotherapy for their advanced non-small cell lung cancer (NSCLC). |
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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 | 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) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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 | Yes |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 18 |
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 | Yes |
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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End of study occurs when all of the following criteria have been satisfied: 1. Thirty days after all patients have stopped protocol treatment 2. The trial is mature for the analysis of the primary endpoint as defined in the protocol 3. The database has been fully cleaned and frozen for this analysis
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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 | 6 |
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 | 10 |