Gefitinib Long-term Survivor Study
9. marts 2022 opdateret af: 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
Studieoversigt
Status
Afsluttet
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
59
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Beijing
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Beijing, Beijing, Kina
- Research Site
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Fujian
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Fuzhou, Fujian, Kina
- Research Site
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Guangdong
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Guangzhou, Guangdong, Kina
- Research Site
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He Nan
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Zhengzhou, He Nan, Kina
- Research Site
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Hebei
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Shijiazhuang, Hebei, Kina
- Research Site
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Hubei
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Wuhan, Hubei, Kina
- Research Site
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Jiangsu
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Nanjing, Jiangsu, Kina
- Research Site
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Jilin
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Changchun, Jilin, Kina
- Research Site
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Liaoning
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Shenyang, Liaoning, Kina
- Research Site
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Shaanxi
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XI An, Shaanxi, Kina
- Research Site
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Shanghai
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Shanghai, Shanghai, Kina
- Research Site
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Shanxi
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Taiyuan, Shanxi, Kina
- Research Site
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Sichuan
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Chengdu, Sichuan, Kina
- Research Site
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Zhejiang
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Hangzhou, Zhejiang, Kina
- Research Site
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
This study will recruit approximately 150 aNSCLC patients who fulfil the inclusion/exclusion criteria
Beskrivelse
Inclusion Criteria:
For inclusion in the long-term survivors group, the study subjects must fulfil the following criteria at the time of screening:
- Provision of informed consent or EC approve informed consent waiver prior to any study specific procedures
- Histological or cytological confirmed locally advanced NSCLC (stage III B) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy
- EGFR mutation positive
- Patients who continuously received gefitinib for at least 3 years without evidence of PD
- Patients with OS ≥ 5 years from NSCLC diagnosis will be preferred
- 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:
- Provision of informed consent or EC approve informed consent waiver prior to any study specific procedures
- Histological or cytological confirmed locally advanced NSCLC (stage III B) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy
- EGFR mutation positive
- Patients who had undergone PD after gefitinib treatment≤3 months (Rapid PD)
- 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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
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Long-term survivors group (case)
EGFR M+ aNSCLC patients who continuously received gefitinib for at least 3 years
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Rapid PD group (control)
EGFR M+ aNSCLC patients who had undergone PD after gefitinib treatment≤3 months
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Proportion of patients with specific genomic alterations(mutation, copy number change and fusion) of short or long-term survivors
Tidsramme: at time of sample collection before Gefitinib treatment initiation, up to 10 years before study start
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at time of sample collection before Gefitinib treatment initiation, up to 10 years before study start
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Sex
Tidsramme: 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
|
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Age
Tidsramme: at time of Gefitinib treatment initiation, up to 10 years before study start
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at time of Gefitinib treatment initiation, up to 10 years before study start
|
|
Pre-existing comorbidities at initiation of gefitinib therapy
Tidsramme: at time of Gefitinib treatment initiation, up to 10 years before study start
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at time of Gefitinib treatment initiation, up to 10 years before study start
|
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Cancer type and date of first ever cancer diagnosis
Tidsramme: at time of Gefitinib treatment initiation, up to 10 years before study start
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at time of Gefitinib treatment initiation, up to 10 years before study start
|
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Histological subtype
Tidsramme: at time of Gefitinib treatment initiation, up to 10 years before study start
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at time of Gefitinib treatment initiation, up to 10 years before study start
|
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Location(s) of metastatic disease at initiation of gefitinib therapy for subjects with TNM stage IV disease
Tidsramme: at time of Gefitinib treatment initiation, up to 10 years before study start
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at time of Gefitinib treatment initiation, up to 10 years before study start
|
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EGFR mutation status
Tidsramme: at time of Gefitinib treatment initiation, up to 10 years before study start
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at time of Gefitinib treatment initiation, up to 10 years before study start
|
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Smoking status
Tidsramme: 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
Tidsramme: 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
|
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Gefitinib treatment patterns- Starting dose
Tidsramme: at time of Gefitinib treatment initiation, up to 10 years before study start
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at time of Gefitinib treatment initiation, up to 10 years before study start
|
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Gefitinib treatment patterns- Dose reductions, treatment interruptions, discontinuation including reasons
Tidsramme: from Gefitinib treatment initiation to Gefitinib treatment discontinuation or study completion, whichever occurred first, up to 12 years
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from Gefitinib treatment initiation to Gefitinib treatment discontinuation or study completion, whichever occurred first, up to 12 years
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Gefitinib treatment patterns- Types of other systemic therapies given in combination with gefitinib
Tidsramme: from Gefitinib treatment initiation to Gefitinib treatment discontinuation or study completion, whichever occurred first, up to 12 years
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from Gefitinib treatment initiation to Gefitinib treatment discontinuation or study completion, whichever occurred first, up to 12 years
|
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Therapeutic agent name post-gefitinib discontinuation
Tidsramme: from gefitinib discontinuation to one year post- gefitinib discontinuation, around one year
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from gefitinib discontinuation to one year post- gefitinib discontinuation, around one year
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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
Tidsramme: 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)
Tidsramme: from Gefitinib treatment initiation to disease progression or study completion, whichever occurred first, up to 12 years
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from Gefitinib treatment initiation to disease progression or study completion, whichever occurred first, up to 12 years
|
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Overval survival (OS)
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
31. oktober 2016
Primær færdiggørelse (Faktiske)
4. juli 2017
Studieafslutning (Faktiske)
4. juli 2017
Datoer for studieregistrering
Først indsendt
12. september 2016
Først indsendt, der opfyldte QC-kriterier
11. oktober 2016
Først opslået (Skøn)
13. oktober 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
24. marts 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. marts 2022
Sidst verificeret
1. december 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- D7913R00020
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