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

19 december 2019 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Study Design:

Studietype

Observationeel

Inschrijving (Werkelijk)

161

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

NSCLC-EGFR mutation positive

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
Afatinib
Geneesmiddel: Afatinib
50, 40, 30 or 20 mg

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Progression Free Survival (PFS) Rate After 12 Months
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Objective Response Rate (ORR)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Boehringer Ingelheim

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

5 maart 2014

Primaire voltooiing (Werkelijk)

31 december 2018

Studie voltooiing (Werkelijk)

31 december 2018

Studieregistratiedata

Eerst ingediend

27 januari 2014

Eerst ingediend dat voldeed aan de QC-criteria

27 januari 2014

Eerst geplaatst (Schatting)

28 januari 2014

Updates van studierecords

Laatste update geplaatst (Werkelijk)

9 januari 2020

Laatste update ingediend die voldeed aan QC-criteria

19 december 2019

Laatst geverifieerd

1 december 2019

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 1200.205

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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