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

19 december 2019 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Study Design:

Studietyp

Observationell

Inskrivning (Faktisk)

161

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Sannolikhetsprov

Studera befolkning

NSCLC-EGFR mutation positive

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
Afatinib
Läkemedel: Afatinib
50, 40, 30 or 20 mg

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Progression Free Survival (PFS) Rate After 12 Months
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Objective Response Rate (ORR)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Boehringer Ingelheim

Publikationer och användbara länkar

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Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

5 mars 2014

Primärt slutförande (Faktisk)

31 december 2018

Avslutad studie (Faktisk)

31 december 2018

Studieregistreringsdatum

Först inskickad

27 januari 2014

Först inskickad som uppfyllde QC-kriterierna

27 januari 2014

Första postat (Uppskatta)

28 januari 2014

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

9 januari 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

19 december 2019

Senast verifierad

1 december 2019

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 1200.205

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