Clinical trial NCT03425825: Treatment Patterns in Advanced Small Cell Lung Cancer (SCLC)
Official title: Treatment Patterns Among Patients With Advanced Small Cell Lung Cancer (SCLC) in Europe
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: Small Cell Lung Cancer (SCLC)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-02-08
Enrollment: 764
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Advanced SCLC patients in 4 European countries (France, Germany, Italy, and United Kingdom \[UK\]).

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Distribution of Patient Demographic Characteristics
timeFrame: At baseline
measure: Distribution of Patient Clinical Characteristics in Relapsed/refractory patients receiving second- or later-line treatment
timeFrame: At baseline
measure: Distribution of Patient Clinical Characteristics in patients with LD-SCLC
timeFrame: At baseline
measure: Distribution of Patient Clinical Characteristics in patients with ED-SCLC
timeFrame: At baseline
measure: Distribution of treatment patterns in patients with ED-SCLC
timeFrame: Approximately 44 months
measure: Distribution of treatment patterns in patients with LD-SCLC
timeFrame: Approximately 44 months
measure: Distribution of treatment patterns in Relapsed/refractory patients receiving second- or later-line treatment
timeFrame: Approximately 44 months
Secondary outcomes:
measure: Composite of SCLC-related healthcare resource utilization (HCRU)
timeFrame: Approximately 44 months
measure: Overall survival (OS)
timeFrame: Approximately 44 months
measure: Progression-free survival (PFS)
timeFrame: Approximately 44 months
measure: Objective response rate (ORR)
timeFrame: Approximately 44 months
measure: Mortality rate
timeFrame: Approximately 44 months
measure: Treatment-related adverse events (AEs) leading to discontinuation
timeFrame: Approximately 44 months
measure: Incidence of surgery as cancer-directed therapy
timeFrame: Approximately 44 months
measure: Incidence of radiation therapy as cancer-directed therapy
timeFrame: Approximately 44 months
measure: Incidence of best supportive care (BSC)
timeFrame: Approximately 44 months
measure: Incidence of palliative care
timeFrame: Approximately 44 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Local Institution
city: London
country: United Kingdom
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: