Treatment Patterns in Advanced Small Cell Lung Cancer (SCLC)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 |
Outcome Measures
Primary Outcome Measures
- Distribution of Patient Demographic Characteristics [At baseline]
Characteristics include: Age/month and year of birth Gender Ethnicity Weight Height Smoking status Alcohol consumption Other relevant risk factors
- Distribution of Patient Clinical Characteristics in Relapsed/refractory patients receiving second- or later-line treatment [At baseline]
Characteristics include: Relevant comorbidities Laboratory parameters Date of initial diagnosis Staging using the VALG system Histology ECOG Performance status Tumor status Symptoms
- Distribution of Patient Clinical Characteristics in patients with LD-SCLC [At baseline]
Characteristics include: Relevant comorbidities Laboratory parameters Date of initial diagnosis Staging using the VALG system Histology ECOG Performance status Tumor status Symptoms
- Distribution of Patient Clinical Characteristics in patients with ED-SCLC [At baseline]
Characteristics include: Relevant comorbidities Laboratory parameters Date of initial diagnosis Staging using the VALG system Histology ECOG Performance status Tumor status Symptoms
- Distribution of treatment patterns in patients with ED-SCLC [Approximately 44 months]
Details on patients prior treatment Patterns will be summarized using descriptive statistics
- Distribution of treatment patterns in patients with LD-SCLC [Approximately 44 months]
Details on patients prior treatment Patterns will be summarized using descriptive statistics
- Distribution of treatment patterns in Relapsed/refractory patients receiving second- or later-line treatment [Approximately 44 months]
Details on patients prior treatment Patterns will be summarized using descriptive statistics
Secondary Outcome Measures
- Composite of SCLC-related healthcare resource utilization (HCRU) [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.
- Overall survival (OS) [Approximately 44 months]
- Progression-free survival (PFS) [Approximately 44 months]
- Objective response rate (ORR) [Approximately 44 months]
- Mortality rate [Approximately 44 months]
- Treatment-related adverse events (AEs) leading to discontinuation [Approximately 44 months]
- Incidence of surgery as cancer-directed therapy [Approximately 44 months]
To describe the use of surgery in the management of LD-SCLC and ED-SCLC patients having relapsed
- Incidence of radiation therapy as cancer-directed therapy [Approximately 44 months]
To describe the use of radiation therapy in the management of LD-SCLC and ED-SCLC patients having relapsed
- Incidence of best supportive care (BSC) [Approximately 44 months]
To describe the use of best supportive care (BSC) in the management of LD-SCLC and ED-SCLC patients having relapsed
- Incidence of palliative care [Approximately 44 months]
To describe the use of palliative care in the management of LD-SCLC and ED-SCLC patients having relapsed
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Local Institution | Barcelona | Spain | 08025 | |
| 2 | Local Institution | London | United Kingdom | N19JY |
Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- CA209-913