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Gefitinib Long-term Survivor Study

9 marzo 2022 aggiornato da: AstraZeneca

A Study of Clinical and Genomic Analysis on Long-term Survivors of EGFR Mutation Positive Advanced Non-small-cell Lung Cancer Patients With Gefitinib Treatment in China

The primary objective is to describe the genomic profile of long-term survivors, especially to find out potential genomic prognosis and/or predictive factors for gefitinib long-term efficacy as compared to rapid PD patients

Panoramica dello studio

Stato

Terminato

Condizioni

Tipo di studio

Osservativo

Iscrizione (Effettivo)

59

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

  • Cina
    • Beijing
      • Beijing, Beijing, Cina
        • Research Site
    • Fujian
      • Fuzhou, Fujian, Cina
        • Research Site
    • Guangdong
      • Guangzhou, Guangdong, Cina
        • Research Site
    • He Nan
      • Zhengzhou, He Nan, Cina
        • Research Site
    • Hebei
      • Shijiazhuang, Hebei, Cina
        • Research Site
    • Hubei
      • Wuhan, Hubei, Cina
        • Research Site
    • Jiangsu
      • Nanjing, Jiangsu, Cina
        • Research Site
    • Jilin
      • Changchun, Jilin, Cina
        • Research Site
    • Liaoning
      • Shenyang, Liaoning, Cina
        • Research Site
    • Shaanxi
      • XI An, Shaanxi, Cina
        • Research Site
    • Shanghai
      • Shanghai, Shanghai, Cina
        • Research Site
    • Shanxi
      • Taiyuan, Shanxi, Cina
        • Research Site
    • Sichuan
      • Chengdu, Sichuan, Cina
        • Research Site
    • Zhejiang
      • Hangzhou, Zhejiang, Cina
        • Research Site

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

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

This study will recruit approximately 150 aNSCLC patients who fulfil the inclusion/exclusion criteria

Descrizione

Inclusion Criteria:

For inclusion in the long-term survivors group, the study subjects must fulfil the following criteria at the time of screening:

  1. Provision of informed consent or EC approve informed consent waiver prior to any study specific procedures
  2. Histological or cytological confirmed locally advanced NSCLC (stage III B) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy
  3. EGFR mutation positive
  4. Patients who continuously received gefitinib for at least 3 years without evidence of PD
  5. Patients with OS ≥ 5 years from NSCLC diagnosis will be preferred
  6. Collect archival tumour tissue before gefitinib treatment (blood and re-biopsy tumour tissue are optional); tumor tissue samples requirements: 1) slices requirements: >1 cm2, thickness 4-5 μm, ≥ 15 slices. or, whole FFPE block; 2) tumor percentage > 20% and necrosis < 30% by pathology QC.

For inclusion in the rapid PD group, the study subjects must fulfil the following criteria:

  1. Provision of informed consent or EC approve informed consent waiver prior to any study specific procedures
  2. Histological or cytological confirmed locally advanced NSCLC (stage III B) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy
  3. EGFR mutation positive
  4. Patients who had undergone PD after gefitinib treatment≤3 months (Rapid PD)
  5. Collect archival tumour tissue before gefitinib treatment (blood and re-biopsy tumour tissue samples are optional) ; tumor tissue samples requirements: 1) slices requirements: >1 cm2, thickness 4-5 μm, ≥ 15 slices. or, whole FFPE block; 2) tumor percentage > 20% and necrosis < 30% by pathology QC.

Exclusion Criteria:

For the active patients, who must not enter the study if any of the following exclusion criteria are fulfilled 1. Patients who disagree to participate this study.

For the terminated patients, who must not enter the study if any of the following exclusion criteria are fulfilled

1. Patients in whose medical objection was recorded to use the existing data from medical practice for scientific research.

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
Long-term survivors group (case)
EGFR M+ aNSCLC patients who continuously received gefitinib for at least 3 years
Rapid PD group (control)
EGFR M+ aNSCLC patients who had undergone PD after gefitinib treatment≤3 months

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Proportion of patients with specific genomic alterations(mutation, copy number change and fusion) of short or long-term survivors
Lasso di tempo: at time of sample collection before Gefitinib treatment initiation, up to 10 years before study start
at time of sample collection before Gefitinib treatment initiation, up to 10 years before study start

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Sex
Lasso di tempo: at time of Gefitinib treatment initiation,up to 10 years before study start
at time of Gefitinib treatment initiation,up to 10 years before study start
Age
Lasso di tempo: at time of Gefitinib treatment initiation, up to 10 years before study start
at time of Gefitinib treatment initiation, up to 10 years before study start
Pre-existing comorbidities at initiation of gefitinib therapy
Lasso di tempo: at time of Gefitinib treatment initiation, up to 10 years before study start
at time of Gefitinib treatment initiation, up to 10 years before study start
Cancer type and date of first ever cancer diagnosis
Lasso di tempo: at time of Gefitinib treatment initiation, up to 10 years before study start
at time of Gefitinib treatment initiation, up to 10 years before study start
Histological subtype
Lasso di tempo: at time of Gefitinib treatment initiation, up to 10 years before study start
at time of Gefitinib treatment initiation, up to 10 years before study start
Location(s) of metastatic disease at initiation of gefitinib therapy for subjects with TNM stage IV disease
Lasso di tempo: at time of Gefitinib treatment initiation, up to 10 years before study start
at time of Gefitinib treatment initiation, up to 10 years before study start
EGFR mutation status
Lasso di tempo: at time of Gefitinib treatment initiation, up to 10 years before study start
at time of Gefitinib treatment initiation, up to 10 years before study start
Smoking status
Lasso di tempo: at time of Gefitinib treatment initiation, up to 10 years before study start
at time of Gefitinib treatment initiation, up to 10 years before study start
ECOG performance status at time of Gefitinib treatment initiation
Lasso di tempo: at time of Gefitinib treatment initiation, up to 10 years before study start
at time of Gefitinib treatment initiation, up to 10 years before study start
Gefitinib treatment patterns- Starting dose
Lasso di tempo: at time of Gefitinib treatment initiation, up to 10 years before study start
at time of Gefitinib treatment initiation, up to 10 years before study start
Gefitinib treatment patterns- Dose reductions, treatment interruptions, discontinuation including reasons
Lasso di tempo: from Gefitinib treatment initiation to Gefitinib treatment discontinuation or study completion, whichever occurred first, up to 12 years
from Gefitinib treatment initiation to Gefitinib treatment discontinuation or study completion, whichever occurred first, up to 12 years
Gefitinib treatment patterns- Types of other systemic therapies given in combination with gefitinib
Lasso di tempo: from Gefitinib treatment initiation to Gefitinib treatment discontinuation or study completion, whichever occurred first, up to 12 years
from Gefitinib treatment initiation to Gefitinib treatment discontinuation or study completion, whichever occurred first, up to 12 years
Therapeutic agent name post-gefitinib discontinuation
Lasso di tempo: from gefitinib discontinuation to one year post- gefitinib discontinuation, around one year
from gefitinib discontinuation to one year post- gefitinib discontinuation, around one year
Documented tumour response (complete or partial response or stable disease, according to RECIST) as determined by the treating physician by clinical judgment and/or imaging after first ever initiation of gefitinib
Lasso di tempo: from Gefitinib treatment initiation to study completion, up to 12 years
from Gefitinib treatment initiation to study completion, up to 12 years
Progression Free Survival (PFS)
Lasso di tempo: from Gefitinib treatment initiation to disease progression or study completion, whichever occurred first, up to 12 years
from Gefitinib treatment initiation to disease progression or study completion, whichever occurred first, up to 12 years
Overval survival (OS)
Lasso di tempo: from Gefitinib treatment initiation to death or study completion, whichever occurred first, up to 12 years
from Gefitinib treatment initiation to death or study completion, whichever occurred first, up to 12 years

Collaboratori e investigatori

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

Sponsor

AstraZeneca

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)

31 ottobre 2016

Completamento primario (Effettivo)

4 luglio 2017

Completamento dello studio (Effettivo)

4 luglio 2017

Date di iscrizione allo studio

Primo inviato

12 settembre 2016

Primo inviato che soddisfa i criteri di controllo qualità

11 ottobre 2016

Primo Inserito (Stima)

13 ottobre 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

24 marzo 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 marzo 2022

Ultimo verificato

1 dicembre 2021

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • D7913R00020

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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