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Treatment Patterns in Advanced Small Cell Lung Cancer (SCLC)

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status

Completed

Conditions

Lung Cancer

Study type

Observational

Funder types

Industry

Identifiers

NCT03425825
CA209-913

Details and patient eligibility

About

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.

Enrollment

764 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

764 participants in 3 patient groups

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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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