E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Non small cell lung cancer |
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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 | 10001183 |
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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 | 10025038 |
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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 assess response rate (RR) obtained with cetuximab-cisplatin-docetaxel in previously untreated patients with locally advanced or metastatic NSCLC with favorable vs unfavorable FcgammaR genotypes. |
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E.2.2 | Secondary objectives of the trial |
-To assess time to progression (TTP) obtained with cetuximab-cisplatin-docetaxel in untreated patients with locally advanced or metastatic NSCLC with favorable vs unfavorable FcgammaR genotypes and EGFR Intron-1 genotypes. - To assess toxicity obtained with cetuximab-cisplatin-docetaxel in patients with locally advanced or metastatic NSCLC with favorable vs unfavorable FcgammaR genotypes and EGFR Intron-1 genotypes. - To assess overall survival (OS) obtained with cetuximab-cisplatin-docetaxel in previously untreated patients with locally advanced or metastatic NSCLC with favorable vs unfavorable FcgammaR genotypes and EGFR Intron-1 genotypes. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
FARMACOGENETICA: Versione:1 Data:2008/11/10 Titolo:Valutazione dello status di EGFR e K-ras e della correlazione tra polimorfismi di EGFR-Intron-1 e la risposta al cetuximab. Obiettivi:Valutazione dello status di EGFR (espressione proteica e mutazioni geniche) e delle mutazioni del gene K-ras. Valutazione della correlazione tra polimorfismi di EGFR-Intron-1 e la risposta al cetuximab
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E.3 | Principal inclusion criteria |
The patient must give written (personally signed and dated) informed consent before completing any study related procedure. Males or females >= 18 years and < 70years. Histologically/citologically confirmed non-small-cell lung cancer (NSCLC). Unresectable stage IIIB-IV NSCLC. ECOG performance status <= 1. Life expectancy >= 12 weeks. Adequate hematological, hepatic and renal functions. Prior radiotherapy allowed, only in case of presence of at least one measurable lesion outside an irradiated area. Radiotherapy must have been completed at least 2 weeks before registration. At baseline, presence of at least one measurable target lesion according to RECIST criteria Absence of any psychological, familial, sociological or geographical conditions potentially hampering compliance with the study protocol and follow-up schedule. |
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E.4 | Principal exclusion criteria |
Any prior systemic anticancer therapy including cytotoxic therapy, targeted agents and experimental therapy for advanced disease; The administration of neoadjuvant or adjuvant chemotherapy is allowed as long as it has finalized within 6 months before entering the study. Patients who are: pregnant or lactating;at risk of pregnancy during the study. This must be checked by pregnancy test at study entry. The patient must be receiving a medically accepted contraceptive regimen. Patients with any underlying medical condition that might be aggravated by treatment or which cannot be controlled i.e. patients with active serious infection, diabetes mellitus, patients with concurrent heart failure [New York Heart Association (NYHA) class II-III-IV], or with progressive or unstable angina, patients who have had myocardial infarction within 6 months, and/or poorly controlled hypertension, or pericardial effusion. Documented brain metastases unless the patient has completed local therapy for central nervous system metastases and has been off corticosteroids for at least two weeks before enrollment. History of another malignancy within the past five years except basal cell carcinoma of the skin or carcinoma in situ of the cervix. Treatment with any investigational drug within the 30 days prior to registration. Concomitant treatment with any other anticancer drug. Known hypersensitivity to the study drugs or to drugs with similar chemical structures. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Response rate (RR) obtained with cetuximab-cisplatin-docetaxel in previously untreated patients with locally advanced or metastatic NSCLC with favorable vs unfavorable FcgammaR genotypes. |
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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) | 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 | No |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 30 |
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 | 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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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 | 0 |
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 | 0 |