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GIOTRIF in First Line Therapy of Advanced NSCLC With EGFR-mutations

19 dicembre 2019 aggiornato da: Boehringer Ingelheim

An Observational Study of GIOTRIF (Afatinib) for First Line Therapy in Patients With Advanced Non Small Cell Lung Cancer (NSCLC) Harboring Epidermal Growth Factor Receptor (EGFR)-Mutations.

This observational study will investigate the efficacy, safety, tolerability and symptom control of GIOTRIF (Afatinib) in daily routine first-line therapy in patients with locally advanced or metastatic NSCLC harboring EGFR-mutations. Eligible NSCLC patients, for whom the treating physician has decided to initiate treatment with GIOTRIF in first line according to the local label, will be followed up for approximately 24 months.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Study Design:

Tipo di studio

Osservativo

Iscrizione (Effettivo)

161

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

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

Metodo di campionamento

Campione di probabilità

Popolazione di studio

NSCLC-EGFR mutation positive

Descrizione

Inclusion criteria:

  • EGFR- tyrosine kinase inhibitor (TKI) naive patients with histologically confirmed locally advanced or metastatic NSCLC with activating EGFR-mutations
  • Age >= 18 years
  • No diagnostic or therapeutic measures beyond routine clinical practice are required
  • Patients for whom the treating physician has decided to initiate treatment with GIOTRIF
  • Written informed consent prior inclusion

Exclusion criteria:

  • Contraindication for Afatinib according to the Summary of Product characteristics
  • Participation in another clinical study until 30 days after end of treatment
  • Prior systemic chemotherapy (Neo-/adjuvant therapy is permitted)
  • Previous treatment with an EGFR-tyrosine kinase inhibitor
  • Patients not willing or not able to fill in quality of life questionnaires
  • Patients with missing or impaired legal capacity
  • Pregnancy

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

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Afatinib
Droga: Afatinib
50, 40, 30 or 20 mg

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Progression Free Survival (PFS) Rate After 12 Months
Lasso di tempo: After 12 months
The rate (probability) of being progression free after 12 months. PFS is defined as the time from first administration of the trial drug until objective tumor progression or death. The rate is the Kaplan-Meier estimated percent probability.
After 12 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Objective Response Rate (ORR)
Lasso di tempo: From the initial dose of study drug until end of the treatment period, up to 48 months.
Objective response rate is calculated as a percentage of participants with complete response (CR) or partial response (PR) (i.e CR+PR) as best unconfirmed response. Here CR and PR were determined by investigators by using RECIST/WHO/clinical evidence as investigators deemed appropriate.
From the initial dose of study drug until end of the treatment period, up to 48 months.
Disease Control Rate (DCR)
Lasso di tempo: From the initial dose of study drug until end of the treatment period, up to 48 months.
Percentage of participants with controlled disease (CR + PR + stable disease (SD)) as best unconfirmed response. CR, PR and SD were determined by investigators by using RECIST/WHO/clinical evidence as investigators deemed appropriate
From the initial dose of study drug until end of the treatment period, up to 48 months.
Progression Free Survival (PFS)
Lasso di tempo: From first administration of the trial drug until objective tumour progression or death, up to 48 months.
PFS was measured from start of therapy until progression or death, whichever came first. Progression was defined as the minimum of the first examination with progression and the date of progression documented by the treating physician. One day was added to the corresponding date. Patients without documented progression and not known to have died were censored at their date of last examination and one day was added. Median was derived by Kaplan Meier methods.
From first administration of the trial drug until objective tumour progression or death, up to 48 months.
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Lasso di tempo: From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
Percentage of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs).
From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
Toxicity and Side-effect Profile: Incidence of Diarrhea, Skin Reactions, Stomatitis and Paronychia
Lasso di tempo: From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
Toxicity and side-effect profile: incidence of diarrhea, skin reactions, stomatitis and paronychia. Skin reactions: acne, dermatitis acneiform, dry skin, pruritus, rash, rash maculo-papular, rash pustular.
From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
Treatment Duration
Lasso di tempo: From the initial dose of study drug until end of the treatment period, up to 48 months.
Duration of treatment with afatinib is calculated as Date of last administration + 1 day - Date of first administration.
From the initial dose of study drug until end of the treatment period, up to 48 months.
Symptom Control - Time to Worsening (Cough, Dyspnea and Pain)
Lasso di tempo: Up to 48 months
Symptom control was evaluated for cough, dyspnea and pain. Time to deterioration was calculated from date of baseline European Organisation for Research and Treatment of Cancer (EORTC) questionnaire until date of the EORTC questionnaire, where the first deterioration was measured. Patients without deterioration were censored at their date of last answered EORTC questionnaire, where the corresponding scale is evaluable. Participants had to select one answer on a scale ranging from 1=Not at All to 4=Very Much for questions 1 to 28 and 31 to 43 and on scale ranging from 1=Very Bad to 7=Excellent for questions 29 and 30. Afterwards, these scale scores were linearly transformed such that all scales ranged from 0 to 100, where higher scores represented higher level of symptoms.
Up to 48 months
Percentage of Participants With Treatment Modification
Lasso di tempo: From the initial dose of study drug until end of the treatment period, up to 48 months.
Percentage of participants with treatment modification was calculated as percentage of participants with any dose reduction, dose escalation or any modification.
From the initial dose of study drug until end of the treatment period, up to 48 months.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Boehringer Ingelheim

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.

Collegamenti utili

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 (Effettivo)

5 marzo 2014

Completamento primario (Effettivo)

31 dicembre 2018

Completamento dello studio (Effettivo)

31 dicembre 2018

Date di iscrizione allo studio

Primo inviato

27 gennaio 2014

Primo inviato che soddisfa i criteri di controllo qualità

27 gennaio 2014

Primo Inserito (Stima)

28 gennaio 2014

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 gennaio 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

19 dicembre 2019

Ultimo verificato

1 dicembre 2019

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 1200.205

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 .

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