- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02932345
Gefitinib Long-term Survivor Study
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
Studieoversikt
Status
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
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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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
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
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Sex
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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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
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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
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at time of Gefitinib treatment initiation, up to 10 years before study start
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ECOG performance status at time of Gefitinib treatment initiation
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- 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
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from Gefitinib treatment initiation to study completion, up to 12 years
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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
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from Gefitinib treatment initiation to death or study completion, whichever occurred first, up to 12 years
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- D7913R00020
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