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Treatment Patterns in Advanced Small Cell Lung Cancer (SCLC)

11. januar 2022 oppdatert av: Bristol-Myers Squibb

Treatment Patterns Among Patients With Advanced Small Cell Lung Cancer (SCLC) in Europe

Non-interventional, retrospective study of advanced SCLC patients in 4 European countries (France, Germany, Italy, and United Kingdom [UK]) with the aim to produce evidence across different SCLC treatment lines to characterize the clinical and economic burden of the disease in Europe.

Studieoversikt

Status

Fullført

Forhold

Studietype

Observasjonsmessig

Registrering (Faktiske)

764

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Spania
      • Barcelona, Spania, 08025
        • Local Institution
  • Storbritannia
      • London, Storbritannia, N19JY
        • Local Institution

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

Ikke-sannsynlighetsprøve

Studiepopulasjon

Advanced SCLC patients in 4 European countries (France, Germany, Italy, and United Kingdom [UK]).

Beskrivelse

Inclusion Criteria:

Cohort 1 and 2:

  • Patients 18 years of age or older at SCLC diagnosis
  • Confirmed diagnosis of SCLC within the patient identification period (between October 2013 and October 2015)
  • Initiated on first-line treatment (radiotherapy and/or chemotherapy) for their SCLC
  • Full oncology medical history for the mandatory variables of the study available in the participating center from day of diagnosis until the end of follow-up or death (whichever occurs first)
  • Signed informed consent (where required as per local requirements)

Cohort 3:

  • Patients 18 years of age or older at SCLC diagnosis
  • Confirmed diagnosis of SCLC not earlier than October 2013
  • Initiated on second-line treatment due to relapse after first-line therapy not later than August 2016
  • Full oncology medical history for the mandatory variables of the study available in the participating center from day of diagnosis until the end of follow-up or death (whichever occurs first)
  • Signed informed consent (where required as per local requirements)

Exclusion Criteria:

  • Participants with previous malignancies (except non-melanoma skin cancers, and in situ cancers such as the following: bladder, gastric, colon, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to first treatment and no additional therapy is required or anticipated to be required during the study period.

Other Inclusion/Exclusion criteria may apply

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
LD-SCLC receiving 1st line treatment
patients with LD-SCLC receiving first-line treatment, including potential maintenance treatment
ED-SCLC receiving 1st line treatment
patients with ED-SCLC receiving first-line treatment, including potential maintenance treatment
relapsed/refractory receiving 2nd or later-line treatment
relapsed/refractory patients receiving second- or later-line treatment

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Distribution of Patient Demographic Characteristics
Tidsramme: At baseline

Characteristics include:

Age/month and year of birth Gender Ethnicity Weight Height Smoking status Alcohol consumption Other relevant risk factors
At baseline
Distribution of Patient Clinical Characteristics in Relapsed/refractory patients receiving second- or later-line treatment
Tidsramme: At baseline

Characteristics include:

Relevant comorbidities Laboratory parameters Date of initial diagnosis Staging using the VALG system Histology ECOG Performance status Tumor status Symptoms
At baseline
Distribution of Patient Clinical Characteristics in patients with LD-SCLC
Tidsramme: At baseline

Characteristics include:

Relevant comorbidities Laboratory parameters Date of initial diagnosis Staging using the VALG system Histology ECOG Performance status Tumor status Symptoms
At baseline
Distribution of Patient Clinical Characteristics in patients with ED-SCLC
Tidsramme: At baseline

Characteristics include:

Relevant comorbidities Laboratory parameters Date of initial diagnosis Staging using the VALG system Histology ECOG Performance status Tumor status Symptoms
At baseline
Distribution of treatment patterns in patients with ED-SCLC
Tidsramme: Approximately 44 months
Details on patients prior treatment Patterns will be summarized using descriptive statistics
Approximately 44 months
Distribution of treatment patterns in patients with LD-SCLC
Tidsramme: Approximately 44 months
Details on patients prior treatment Patterns will be summarized using descriptive statistics
Approximately 44 months
Distribution of treatment patterns in Relapsed/refractory patients receiving second- or later-line treatment
Tidsramme: Approximately 44 months
Details on patients prior treatment Patterns will be summarized using descriptive statistics
Approximately 44 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Composite of SCLC-related healthcare resource utilization (HCRU)
Tidsramme: Approximately 44 months
HCRU will include hospitalizations, emergency visits, outpatient visits, treatments received (including treatments prescribed to manage AEs), diagnostic tests and procedures, surgery, and ancillary services.
Approximately 44 months
Overall survival (OS)
Tidsramme: Approximately 44 months
Approximately 44 months
Progression-free survival (PFS)
Tidsramme: Approximately 44 months
Approximately 44 months
Objective response rate (ORR)
Tidsramme: Approximately 44 months
Approximately 44 months
Mortality rate
Tidsramme: Approximately 44 months
Approximately 44 months
Treatment-related adverse events (AEs) leading to discontinuation
Tidsramme: Approximately 44 months
Approximately 44 months
Incidence of surgery as cancer-directed therapy
Tidsramme: Approximately 44 months
To describe the use of surgery in the management of LD-SCLC and ED-SCLC patients having relapsed
Approximately 44 months
Incidence of radiation therapy as cancer-directed therapy
Tidsramme: Approximately 44 months
To describe the use of radiation therapy in the management of LD-SCLC and ED-SCLC patients having relapsed
Approximately 44 months
Incidence of best supportive care (BSC)
Tidsramme: Approximately 44 months
To describe the use of best supportive care (BSC) in the management of LD-SCLC and ED-SCLC patients having relapsed
Approximately 44 months
Incidence of palliative care
Tidsramme: Approximately 44 months
To describe the use of palliative care in the management of LD-SCLC and ED-SCLC patients having relapsed
Approximately 44 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Bristol-Myers Squibb

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

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 (Faktiske)

15. desember 2016

Primær fullføring (Faktiske)

24. januar 2019

Studiet fullført (Faktiske)

24. januar 2019

Datoer for studieregistrering

Først innsendt

13. oktober 2017

Først innsendt som oppfylte QC-kriteriene

1. februar 2018

Først lagt ut (Faktiske)

8. februar 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

26. januar 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. januar 2022

Sist bekreftet

1. januar 2022

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CA209-913

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Sponsorer og samarbeidspartnere

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Forhold

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