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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
| 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) |
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Inclusion Criteria:
Cohort 1 and 2:
Cohort 3:
Exclusion Criteria:
Other Inclusion/Exclusion criteria may apply
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Advanced SCLC patients in 4 European countries (France, Germany, Italy, and United Kingdom [UK]).
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Barcelona | 08025 | Spain | |||
| Local Institution |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 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 |
| 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 |
| London |
| N19JY |
| United Kingdom |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |