An Observational Study of Erlotinib (Tarceva) as Second-line Treatment in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer After Failure of Pemetrexed in First-line Therapy (TIME)
23. november 2015 oppdatert av: Hoffmann-La Roche
Prospective, Open-label, Multicenter, National, Non-interventional Phase IV Trial of the Effectiveness, Safety and Tolerability of Tarceva as Second-line Treatment of Patients With Advanced Non-small Cell Lung Cancer (NSCLC), After Failure of First-line Treatment With a Pemetrexed-containing Chemotherapy Regimen
This prospective, multicenter observational study will evaluate the efficacy, safety, and tolerability of Tarceva (erlotinib) as second-line treatment in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed after pemetrexed-containing first-line chemotherapy.
Eligible patients will be followed until withdrawal of consent, lost-to-follow-up, or study termination, whichever occurs first.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Observasjonsmessig
Registrering (Faktiske)
57
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Aalst, Belgia, 9300
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Antwerpen, Belgia, 2020
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Boussu, Belgia, 7360
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Bruxelles, Belgia, 1200
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Charleroi, Belgia, 6000
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Dendermonde, Belgia, 9200
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Duffel, Belgia, 2570
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Edegem, Belgia, 2650
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Frameries, Belgia, 7080
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Genk, Belgia, 3600
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Gilly, Belgia, 6060
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Gosselies, Belgia, 6041
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Liege, Belgia, 4000
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Mons, Belgia, 7000
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Montegnée, Belgia, 4420
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Namur, Belgia, 5000
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Ottignies, Belgia, 1340
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Roeselare, Belgia, 8800
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Sint Niklaas, Belgia, 9100
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Tournai, Belgia, 7500
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Turnhout, Belgia, 2300
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
Patients with locally advanced or metastatic non-small cell lung cancer initiated on second-line Tarceva therapy after first-line pemetrexed-containing chemotherapy.
Beskrivelse
Inclusion Criteria:
- Adult patients ≥ 18 years of age.
- Histologically or cytologically documented locally advanced or metastatic non-small cell lung cancer (inoperable Stage III or IV according to the 7th TNM Classification of Malignant Tumors).
- Experiencing disease progression after pemetrexed-containing first-line chemotherapy regimen.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Initiated on second-line treatment with Tarceva at the most 4 weeks prior to study entry at baseline (date of signature of informed consent).
Exclusion Criteria:
- Prior chemotherapy/targeted therapy after disease progression after first-line treatment in the advanced non-small cell lung cancer (NSCLC) setting.
- Contraindication for Tarceva according to the Summary of Product characteristics.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
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Erlotinib
Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics.
The recommended daily oral dose of erlotinib is 150 mg.
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Erlotinib was supplied as tablets in the retail product Tarceva.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Progression-free Survival
Tidsramme: Baseline to the end of the study (up to 2 years)
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Progression-free survival was defined as the time from the first dose of erlotinib to disease progression or death from any cause, whichever occurred earlier.
Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter of target lesions recorded since treatment started, or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
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Baseline to the end of the study (up to 2 years)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Best Overall Response
Tidsramme: Baseline to the end of the study (up to 2 years)
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Reported are the percentage of participants with a best overall response of complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD).
The best overall response to treatment was determined by the Response Evaluation Criteria in Solid Tumors (RECIST).
A CR was defined as the disappearance of all target lesions (TL) or the disappearance of all non-TLs.
A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD.
SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since treatment started for TLs and the persistence of 1 or more non-TL(s).
PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.
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Baseline to the end of the study (up to 2 years)
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Overall Survival
Tidsramme: Up to 2 years
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Overall survival was defined as the time from Baseline until death from any cause.
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Up to 2 years
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Percentage of Participants Who Developed Rash
Tidsramme: Up to 2 years
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Up to 2 years
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Percentage of Participants Who Developed Diarrhea
Tidsramme: Up to 2 years
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Up to 2 years
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. september 2011
Primær fullføring (Faktiske)
1. august 2013
Studiet fullført (Faktiske)
1. august 2013
Datoer for studieregistrering
Først innsendt
10. august 2012
Først innsendt som oppfylte QC-kriteriene
10. august 2012
Først lagt ut (Anslag)
14. august 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
28. desember 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. november 2015
Sist bekreftet
1. november 2015
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i luftveiene
- Neoplasmer
- Lungesykdommer
- Neoplasmer etter nettsted
- Neoplasmer i luftveiene
- Thoracale neoplasmer
- Karsinom, bronkogent
- Bronkiale neoplasmer
- Lungeneoplasmer
- Karsinom, ikke-småcellet lunge
- Molekylære mekanismer for farmakologisk virkning
- Enzymhemmere
- Antineoplastiske midler
- Proteinkinasehemmere
- Erlotinib hydroklorid
Andre studie-ID-numre
- ML25708
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