Treatment Patterns in Advanced Small Cell Lung Cancer (SCLC)

NCT ID: NCT03425825

Last Updated: 2022-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

764 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-15

Study Completion Date

2019-01-24

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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LD-SCLC receiving 1st line treatment

patients with LD-SCLC receiving first-line treatment, including potential maintenance treatment

No interventions assigned to this group

ED-SCLC receiving 1st line treatment

patients with ED-SCLC receiving first-line treatment, including potential maintenance treatment

No interventions assigned to this group

relapsed/refractory receiving 2nd or later-line treatment

relapsed/refractory patients receiving second- or later-line treatment

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Barcelona, , Spain

Site Status

Local Institution

London, , United Kingdom

Site Status

Countries

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Spain United Kingdom

Related Links

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Other Identifiers

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CA209-913

Identifier Type: -

Identifier Source: org_study_id

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