Treatment Patterns Among Patients With Advanced Small Cell Lung Cancer (SCLC) in Europe
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 764
- Locations
- 1
- Primary Endpoint
- Distribution of Patient Clinical Characteristics in patients with ED-SCLC
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
- •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
Outcomes
Primary Outcomes
Distribution of Patient Clinical Characteristics in patients with ED-SCLC
Time Frame: 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 LD-SCLC
Time Frame: 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
Time Frame: Approximately 44 months
Details on patients prior treatment Patterns will be summarized using descriptive statistics
Distribution of Patient Clinical Characteristics in Relapsed/refractory patients receiving second- or later-line treatment
Time Frame: 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
Time Frame: 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 Demographic Characteristics
Time Frame: At baseline
Characteristics include: Age/month and year of birth Gender Ethnicity Weight Height Smoking status Alcohol consumption Other relevant risk factors
Distribution of treatment patterns in patients with ED-SCLC
Time Frame: Approximately 44 months
Details on patients prior treatment Patterns will be summarized using descriptive statistics
Secondary Outcomes
- Progression-free survival (PFS)(Approximately 44 months)
- Objective response rate (ORR)(Approximately 44 months)
- Incidence of surgery as cancer-directed therapy(Approximately 44 months)
- Incidence of best supportive care (BSC)(Approximately 44 months)
- Incidence of palliative care(Approximately 44 months)
- Composite of SCLC-related healthcare resource utilization (HCRU)(Approximately 44 months)
- Incidence of radiation therapy as cancer-directed therapy(Approximately 44 months)
- Overall survival (OS)(Approximately 44 months)
- Mortality rate(Approximately 44 months)
- Treatment-related adverse events (AEs) leading to discontinuation(Approximately 44 months)