| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Advanced (stage III or IV) non-small cell lung cancer (NSCLC) previously treated with a platinum based chemotherapy |
| NSCLC avanzato (stadio III o IV) precedentemente trattato con chemioterapia a base di platino. |
|
| E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 14.1 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10061873 |
| E.1.2 | Term | Non-small cell lung cancer |
| E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| 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 determine if the administration of Tarceva after disease progression on standard platinum-based chemotherapy in the treatment of NSCLC results in improved overall survival when compared to Alimta (pemetrexed) or Taxotere (docetaxel). |
| Determinare se la somministrazione di TarcevaTM dopo la progressione della malattia in seguito a chemioterapia standard a base di platino nel trattamento del NSCLC risulta in un miglioramento della sopravvivenza rispetto ad Alimta (pemetrexed) o Taxotere (docetaxel). |
|
| E.2.2 | Secondary objectives of the trial |
| 1.To compare overall survival between the treatment arms in patients with:EGFR protein expression(IHC)positive,EGFR protein expression(IHC)negative.2.To compare progression free survival(PFS)between the treatment arms for all patients and in patients with:EGFR protein expression(IHC)positive,EGFR protein expression(IHC)negative.3.To compare the response rate between the treatment arms.4.To perform exploratory evaluations of available tumourtissue for biological or genomic determinants of outcome, including but not limited to EGFR and K-ras mutational status and EGFR and HER2 expression status and other downstream targets.5.To compare time to symptom progression between the treatment arms.6.To evaluate the safety profile of administering Tarceva£ª after disease progression on a standard platinum based chemotherapy in the treatment of NSCLC and compared with Alimta and Taxotere.7.To investigate by a population analysis approach the pharmacokine |
| 1Confr.la sopravv generale tra i gruppi di tratt nei paz con:Espressione positiva(IHC)della proteina EGFR Espressione negativa(IHC)della proteina EGFR 2Confr.la PFS nei gruppi di tratt per tutti i paz e per i paz con:IHC della proteina EGFR IHC della proteina EGFR 3Confr.il tasso di risp nei gruppi di tratt 4Eseguire valut esplorative del tessuto tumorale disponibile per i determinanti biologici o genomici che possono influenzare l esito,inclusi ma non limitati allo stato mutazionale di EGFR e K-ras e lo stato di espressione di EGFR e HER2 e altri target a valle 5Confr.il T diprogr sintomi tra i gruppi di tratt 6Valut profilo di sicur.della sommin di TarcevaTM dopo laprogr della malattia in seguito a chemioter standard a base di platino nel tratt del NSCLC confront con quello di Alimta e Taxotere7 Valut la PK di TarcevaTM nella pop target,inclusa l influenza delle covar e fornire stime posthoc di esposizione.Verrà valutata la relazione tra esposizione a erlotinib e param di sicur.e eff |
|
| 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 |
PHARMACOGENETIC:
Vers:A-RG
Date:2005/07/13
Title:
Objectives:
|
FARMACOGENETICA:
Vers:A-RG
Data:2005/07/13
Titolo:Roche Sample Repository Research Project in association with protocol BO18602
Obiettivi:To obtain a single blood sample from consenting patients enrolled in associated study BO18602 for pharmacogenetic and genetic research analysis.
|
|
| E.3 | Principal inclusion criteria |
| 1. Patients with histologically documented, locally advanced or recurrent (stage IIIB and not amenable for combined modality treatment) or metastatic (Stage IV) non-small cell lung cancer. Formalin-fixed, paraffin-embedded tumour tissue samples representative of the tumour will be provided to the sponsor within 3 weeks of the patient starting platinum-based chemotherapy`ˆ—. This Is A Mandatory Requirement For Study Entry. 2. Patients must have measurable disease according to the RECIST criteria. 3. Previous adjuvant or neo-adjuvant treatment is permitted if completed `‰¥ 6 months before start of chemotherapy. 4. ECOG performance status of 0 - 1 |
| 1. Pazienti con NSCLC istologicamente documentato, localmente avanzato o ricorrente (stadio III e non suscettibile al trattamento in modalita' combinata) o metastatico (stadio IV) e che soddisfano i criteri di selezione. 2. Malattia misurabile secondo i criteri RECIST. 3. Precedente terapia adiuvante o neo-adiuvante terminata almeno 6 mesi prima della sperimentazione. 4. ECOG performance status di 0-1. 5. Consenso informato scritto (firmato) per l'utilizzo di campioni di neoplasia. |
|
| E.4 | Principal exclusion criteria |
| 1. Prior exposure to agents directed at the HER axis (e.g. gefitinib, cetuximab, trastuzamab). 2. Prior agents directed at Alimta molecular targets (i.e., TS or DHFR inhibitors). 3. Prior chemotherapy or therapy with systemic anti-neoplastic therapy (e.g., monoclonal antibody therapy or any experimental therapy) for advanced disease other than the permitted platinum-based chemotherapies. Prior surgery and/or localised irradiation is permitted. 4. Any unstable systemic disease (including active infections, significant cardiovascular disease, [including myocardial infarction within the previous year], any significant hepatic, renal or metabolic disease) metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of study medication(s) or that might affect the interpretation of the results or render the patient at high risk from treatment complications. 5. Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer). 6. Patients are excluded if they have brain metastasis or spinal cord compression that 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 (clinically stable imaging) for at least 2 months will also cause patients to be excluded. 7. Patients who are at risk (in the investigator s opinion) of transmitting human immunodeficiency virus (HIV) through blood or other body fluids are excluded. 8. Any inflammatory changes of the surface of the eye. 9. Patients who cannot take oral medication, who require intravenous alimentation, have had prior surgical procedures affecting absorption, or have active peptic ulcer disease. 10. Patients who are unable to interrupt acetylic salicylic acid therapy (where aspirin dose is `‰¥ 1.3 g/day). 11. Nursing mothers. 12. Severe hypersensitivity to Tarceva or to any of the excipients. (see the Tarceva SPC) or to the excipients in Alimta or Taxotere (see respective SPCs). 13. History of severe hypersensitivity reactions to Taxotere or to other drugs formulated with polysorbate 80. |
| 1. Precedenti trattamenti con farmaci HER-specifici. 2. Precedenti trattamenti con inibitori TS o DHFR. 3.Precedente chemioterapia o terapia con farmaci antineoplastici sistemici (i.e.: terapia con anticorpi monoclonali o terapie sperimentali). Sono consentiti precedenti interventi chirurgici e/o radioterapia localizzata. 4. Presenza di malattie sistemiche (infezioni in atto, malattie cardiovascolari, epatiche, renali o metaboliche significative), disfunzioni metaboliche, controindicazioni al trattamento in studio sulla base della valutazione clinica e dei parametri di laboratorio che possano alterare l`interpretazione dei risultati o causare elevato rischio di complicanze. 5. Diagnosi di altre neoplasie nei 5 anni precedenti (escluso carcinoma della cervice in istu e carcinoma cutaneo basale o squamoso adeguatamente trattato) 6. Evidenza di metastasi cerebrali o compressione spinale non trattata chirurgicamente e/o con radioterapia in via definitiva; la precedente diagnosi e trattamento di metastasi al CNS o compressione spinale senza evidenza di stabilizzazione della malattia per almeno 2 mesi portera` all`esclusione dallo studio. 7. Pazienti a rischio di trasmissione di HIV. 8. Alterazioni di tipo infiammatorio alla superficie dell`occhio. 9. Pazienti non in grado di assumere terapie per via orale, che necessitino di alimentazione per via endovenosa, con precedenti interventi chirurgici che abbiano alterato l`assorbimento o con ulcera peptica in atto. 10. Pazienti non in grado di interrompere la terapia con acido acetilsalicilico (dosi di aspirina > 1.3 g/die). 11. Donne che allattino. 12. Ipersensibilita` severa a Tarceva o agli eccipienti presenti nei farmaci in uso. 13. Precedente storia di ipersensibilita` a Taxotere o a farmaci contenenti polisorbato 80. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| Overall survival (OS). |
| Sopravvivenza totale (OS). |
|
| 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 | Yes |
| 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) | 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.8.2.4 | Number of treatment arms in the trial | 2 |
| 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 | 3 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 15 |
| 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 | No |
| 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
|
| La fine dello studio coincide con l`ultima visita dell`ultimo soggetto inserito nella sperimentazione. |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 0 |
| E.8.9.1 | In the Member State concerned months | 68 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 0 |
| E.8.9.2 | In all countries concerned by the trial months | 68 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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