- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01342965
A Study of Erlotinib (Tarceva) Versus Gemcitabine/Cisplatin as First-line Treatment in Patients With Non-small Cell Lung Cancer With EGFR Mutations
5 febbraio 2015 aggiornato da: Hoffmann-La Roche
A Multicenter, Open-label, Randomized Phase III Study to Evaluate the Efficacy and Safety of Erlotinib (Tarceva®) Versus Gemcitabine/Cisplatin as the First-line Treatment for Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC) Patients With Mutations in the Tyrosine Kinase Domain of Epidermal Growth Factor Receptor (EGFR) in Their Tumors
This open-label, randomized, parallel arm study assessed the efficacy and safety of Tarceva (erlotinib) versus gemcitabine/cisplatin combination chemotherapy as first-line treatment in patients with stage IIIB/IV non-small cell lung cancer with epidermal growth factor receptor (EGFR) mutations in their tumours.
Patients were randomized to receive either Tarceva 150 mg orally daily or 3-week cycles of gemcitabine 1250 mg/m^2 intravenously (iv) on Days 1 and 8 plus cisplatin 75 mg/m^2 iv on Day 1.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
217
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Beijing, Cina, 101149
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Beijing, Cina, 100071
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Changchun, Cina, 130012
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ChongQing, Cina, 400042
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Chongqing, Cina, 400038
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Fuzhou, Cina, 350014
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Guangzhou, Cina, 510080
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Hangzhou, Cina, 310016
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Nanjing, Cina, 210002
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Shanghai, Cina, 200032
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Shanghai, Cina, 200433
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Shanghai, Cina, 200030
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Shantou, Cina, 515041
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Wuhan, Cina, 430023
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Xi'an, Cina, 710061
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Davao, Filippine, 8000
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Desmarinas City, Filippine, 4114
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Manila, Filippine, 1000
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Quezon City, Filippine, 1104
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San Juan, Filippine, 1500
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Kelantan, Malaysia, 16150
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Kuala Lumpur, Malaysia, 59100
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Kuala Lumpur, Malaysia, 50603
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Nilai, Malaysia, 71800
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Pahang, Malaysia, 25100
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Petaling Jaya, Malaysia, 46150
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Petaling Jaya, Selangor, Malaysia, 46050
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Pulau Pinang, Malaysia, 11600
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Adult participants, ≥ 18 years of age.
- Locally advanced or recurrent (stage IIIB) or metastatic (stage IV) non-small cell lung cancer.
- Presence of epidermal growth factor receptor (EGFR) mutations in tumours.
- Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 criteria.
- European Cooperative Oncology Group (ECOG) performance status ≤ 2.
Exclusion Criteria:
- Prior exposure to agents directed at the human epidermal receptor (HER) axis (eg, but not limited to erlotinib, gefitinib, cetuximab, or trastuzumab).
- Prior chemotherapy or systemic anti-neoplastic therapy for advanced disease.
- Lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or active gastroduodenal ulcer disease.
- Any inflammatory changes of the surface of the eye.
- ≥ Grade 2 peripheral neuropathy.
- History of any other malignancies within 5 years, except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer.
- Brain metastasis or spinal cord compression that has not yet been definitely treated with surgery and/or radiation, or treated but without evidence of stable disease for at least 2 months.
- Human immunodeficiency virus (HIV) infection.
- Pregnant, nursing, or lactating women.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Erlotinib
Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity.
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Erlotinib was supplied as tablets.
Altri nomi:
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Comparatore attivo: Chemotherapy
Participants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first.
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Cisplatin and gemcitabine were locally sourced with commercial products.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Investigator-assessed Duration of Progression-free Survival
Lasso di tempo: Baseline to the data cut-off date of 20 Jul 2012 (1 year, 4 months)
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The duration of progression-free survival was defined as the time from randomization to disease progression (PD) or death from any cause, whichever occurs first.
PD was defined as: (1) At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this may include the baseline sum).
The sum must also demonstrate an absolute increase of at least 5 mm.
(2) An unequivocal progression of existing non-target lesions.
When the patient has measurable disease, the overall tumor burden must have increased sufficiently to merit discontinuation of therapy.
When the patient has only non-measurable disease, the increase in overall disease burden should be comparable in magnitude to the increase that would be required to declare PD for measurable disease.
(3) The appearance of new malignant lesions.
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Baseline to the data cut-off date of 20 Jul 2012 (1 year, 4 months)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Percentage of Responders as Assessed by the Investigator
Lasso di tempo: Baseline to the data cut-off date of 19 Nov 2012 (1 year, 8 months)
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A responder was defined as a participant with either a complete response (CR) or a partial response (PR), as determined using the Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
A CR was defined as: (1) The disappearance of all target lesions.
Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to < 10 mm.
(2) The disappearance of all non-target lesions and normalization of tumor marker levels.
All lymph nodes must be non-pathological in size (< 10 mm in the short axis).
A PR was defined as: (1) At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
(2) The persistence of 1 or more non-target lesion(s) and/or maintenance of tumor marker levels above normal limits.
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Baseline to the data cut-off date of 19 Nov 2012 (1 year, 8 months)
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Percentage of Participants With Disease Control
Lasso di tempo: Baseline to the data cut-off date of 19 Nov 2012 (1 year, 8 months)
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A participant with disease control was defined as a participant with either a complete response (CR), a partial response (PR), or stable disease (SD), as determined using RECIST v1.1.
A CR was defined as the disappearance of all target lesions (TL).
A PR was defined as at least a 30% decrease in the sum of the longest diameter of TLs taking as reference the Baseline sum longest diameter (SLD).
SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest SLD since treatment started.
For non-TLs, SD was defined as the persistence of 1 or more lesions.
PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the unequivocal progression of existing non-TLs.
A SLD for all TLs will be calculated and reported as the Baseline SLD.
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Baseline to the data cut-off date of 19 Nov 2012 (1 year, 8 months)
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Duration of Response
Lasso di tempo: Baseline to the data cut-off date of 19 Nov 2012 (1 year, 8 months)
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Duration of response was defined as the time from the first documented complete response (CR) or partial response (PR) to the first documented disease progression (PD) or death, whichever occurs first.
A CR was defined as the disappearance of all target lesions (TL).
A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs taking as reference the Baseline SLD.
PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the unequivocal progression of existing non-TLs.
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Baseline to the data cut-off date of 19 Nov 2012 (1 year, 8 months)
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Overall Survival
Lasso di tempo: Baseline to the end of the study (3 years, 1 month)
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Overall survival was defined as the time from the date of randomization to the date of death from any cause.
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Baseline to the end of the study (3 years, 1 month)
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Safety: Incidence of Adverse Events
Lasso di tempo: 36 months
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36 months
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Quality of Life: Functional Assessment of Chronic Illness Therapy - Lung (FACIT-L) Questionnaire
Lasso di tempo: approximately 21 months
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approximately 21 months
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Wen F, Zheng H, Zhang P, Hutton D, Li Q. OPTIMAL and ENSURE trials-based combined cost-effectiveness analysis of erlotinib versus chemotherapy for the first-line treatment of Asian patients with non-squamous non-small-cell lung cancer. BMJ Open. 2018 Apr 13;8(4):e020128. doi: 10.1136/bmjopen-2017-020128.
- Wu YL, Zhou C, Liam CK, Wu G, Liu X, Zhong Z, Lu S, Cheng Y, Han B, Chen L, Huang C, Qin S, Zhu Y, Pan H, Liang H, Li E, Jiang G, How SH, Fernando MCL, Zhang Y, Xia F, Zuo Y. First-line erlotinib versus gemcitabine/cisplatin in patients with advanced EGFR mutation-positive non-small-cell lung cancer: analyses from the phase III, randomized, open-label, ENSURE study. Ann Oncol. 2015 Sep;26(9):1883-1889. doi: 10.1093/annonc/mdv270. Epub 2015 Jun 23.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 marzo 2011
Completamento primario (Effettivo)
1 luglio 2012
Completamento dello studio (Effettivo)
1 aprile 2014
Date di iscrizione allo studio
Primo inviato
26 aprile 2011
Primo inviato che soddisfa i criteri di controllo qualità
26 aprile 2011
Primo Inserito (Stima)
27 aprile 2011
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
24 febbraio 2015
Ultimo aggiornamento inviato che soddisfa i criteri QC
5 febbraio 2015
Ultimo verificato
1 febbraio 2015
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie delle vie respiratorie
- Neoplasie
- Malattie polmonari
- Neoplasie per sede
- Neoplasie delle vie respiratorie
- Neoplasie toraciche
- Carcinoma, broncogeno
- Neoplasie bronchiali
- Neoplasie polmonari
- Carcinoma, polmone non a piccole cellule
- Meccanismi molecolari dell'azione farmacologica
- Inibitori enzimatici
- Agenti antineoplastici
- Inibitori della chinasi proteica
- Erlotinib cloridrato
Altri numeri di identificazione dello studio
- YO25121
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Carcinoma polmonare non a piccole cellule
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National Cancer Institute (NCI)ReclutamentoKita-kyushu Lung Cancer Antigen 1, umanoStati Uniti
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National Cancer Institute (NCI)NCIC Clinical Trials Group; Southwest Oncology Group; Cancer and Leukemia Group BCompletatoCarcinoma a cellule renali a cellule chiare | Cancro a cellule renali in stadio III AJCC v7 | Cancro a cellule renali in stadio II AJCC v7 | Stadio I Renal Cell Cancer AJCC v6 e v7Stati Uniti, Canada, Porto Rico
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National Cancer Institute (NCI)TerminatoCarcinoma a cellule renali a cellule chiare | Carcinoma a cellule renali metastatico | Cancro a cellule renali in stadio III AJCC v7 | Cancro a cellule renali in stadio IV AJCC v7 | Cancro a cellule renali in stadio II AJCC v7 | Stadio I Renal Cell Cancer AJCC v6 e v7Stati Uniti
Prove cliniche su Erlotinib
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National Cancer Institute (NCI)University of Chicago; City of Hope Medical Center; University of Southern California e altri collaboratoriCompletatoCarcinoma polmonare non a piccole celluleStati Uniti
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PfizerCompletatoCarcinoma, polmone non a piccole celluleStati Uniti
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Fox Chase Cancer CenterMillennium Pharmaceuticals, Inc.TerminatoCancro del polmone non a piccole cellule metastatico | Cancro del polmone non a piccole cellule ricorrenteStati Uniti
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M.D. Anderson Cancer CenterCompletato
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New Mexico Cancer Care AllianceCompletatoTumori maligni solidi avanzatiStati Uniti
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University of ChicagoNational Cancer Institute (NCI)CompletatoMesotelioma peritoneale malignoStati Uniti
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Sidney Kimmel Cancer Center at Thomas Jefferson...Genentech, Inc.CompletatoCarcinoma, polmone non a piccole celluleStati Uniti
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Merck Sharp & Dohme LLCCompletatoCarcinoma, polmone non a piccole cellule
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PharmaMarCompletatoTumori solidi maligni avanzatiSpagna, Stati Uniti
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Tragara Pharmaceuticals, Inc.CompletatoCarcinoma polmonare non a piccole cellule ricorrenteStati Uniti