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Gefitinib Long-term Survivor Study

9 maart 2022 bijgewerkt door: 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

Studie Overzicht

Toestand

Beëindigd

Conditie

Studietype

Observationeel

Inschrijving (Werkelijk)

59

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

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

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

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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

Beschrijving

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.

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
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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Proportion of patients with specific genomic alterations(mutation, copy number change and fusion) of short or long-term survivors
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Sex
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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

Medewerkers en onderzoekers

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

Sponsor

AstraZeneca

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)

31 oktober 2016

Primaire voltooiing (Werkelijk)

4 juli 2017

Studie voltooiing (Werkelijk)

4 juli 2017

Studieregistratiedata

Eerst ingediend

12 september 2016

Eerst ingediend dat voldeed aan de QC-criteria

11 oktober 2016

Eerst geplaatst (Schatting)

13 oktober 2016

Updates van studierecords

Laatste update geplaatst (Werkelijk)

24 maart 2022

Laatste update ingediend die voldeed aan QC-criteria

9 maart 2022

Laatst geverifieerd

1 december 2021

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • D7913R00020

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