Treatment Patterns in Advanced Small Cell Lung Cancer (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.

Official Title
-----------------
Treatment Patterns Among Patients With Advanced Small Cell Lung Cancer (SCLC) in Europe

Conditions
-----------------
Lung Cancer

Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LD-SCLC receiving 1st line treatment<br>patients with LD-SCLC receiving first-line treatment, including potential maintenance treatment | |
| ED-SCLC receiving 1st line treatment<br>patients with ED-SCLC receiving first-line treatment, including potential maintenance treatment | |
| relapsed/refractory receiving 2nd or later-line treatment<br>relapsed/refractory patients receiving second- or later-line treatment | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of Patient Demographic Characteristics | Characteristics include: Age/month and year of birth Gender Ethnicity Weight Height Smoking status Alcohol consumption Other relevant risk factors | At baseline | 
| Distribution of Patient Clinical Characteristics in Relapsed/refractory patients receiving second- or later-line treatment | Characteristics include: Relevant comorbidities Laboratory parameters Date of initial diagnosis Staging using the VALG system Histology ECOG Performance status Tumor status Symptoms | At baseline | 
| Distribution of Patient Clinical Characteristics in patients with LD-SCLC | Characteristics include: Relevant comorbidities Laboratory parameters Date of initial diagnosis Staging using the VALG system Histology ECOG Performance status Tumor status Symptoms | At baseline | 
| Distribution of Patient Clinical Characteristics in patients with ED-SCLC | Characteristics include: Relevant comorbidities Laboratory parameters Date of initial diagnosis Staging using the VALG system Histology ECOG Performance status Tumor status Symptoms | At baseline | 
| Distribution of treatment patterns in patients with ED-SCLC | Details on patients prior treatment Patterns will be summarized using descriptive statistics | Approximately 44 months | 
| Distribution of treatment patterns in patients with LD-SCLC | Details on patients prior treatment Patterns will be summarized using descriptive statistics | Approximately 44 months | 
| Distribution of treatment patterns in Relapsed/refractory patients receiving second- or later-line treatment | Details on patients prior treatment Patterns will be summarized using descriptive statistics | Approximately 44 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of SCLC-related healthcare resource utilization (HCRU) | HCRU will include hospitalizations, emergency visits, outpatient visits, treatments received (including treatments prescribed to manage AEs), diagnostic tests and procedures, surgery, and ancillary services. | Approximately 44 months | 
| 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 | To describe the use of surgery in the management of LD-SCLC and ED-SCLC patients having relapsed | Approximately 44 months | 
| Incidence of radiation therapy as cancer-directed therapy | To describe the use of radiation therapy in the management of LD-SCLC and ED-SCLC patients having relapsed | Approximately 44 months | 
| Incidence of best supportive care (BSC) | To describe the use of best supportive care (BSC) in the management of LD-SCLC and ED-SCLC patients having relapsed | Approximately 44 months | 
| Incidence of palliative care | To describe the use of palliative care in the management of LD-SCLC and ED-SCLC patients having relapsed | Approximately 44 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Small Cell Lung Cancer (SCLC)