Treatment Patterns in Advanced Small Cell Lung Cancer (SCLC)

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03425825
• Other study ID #: CA209-913
• Status: Completed
• Start date: December 15, 2016
• Est. completion date: January 24, 2019

Study information

• Verified date: January 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 764
• Est. completion date: January 24, 2019
• Est. primary completion date: January 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Locations

Country	Name	City	State
Spain	Local Institution	Barcelona
United Kingdom	Local Institution	London

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Distribution of treatment patterns in patients with ED-SCLC	Details on patients prior treatment Patterns will be summarized using descriptive statistics	Approximately 44 months
Primary	Distribution of treatment patterns in patients with LD-SCLC	Details on patients prior treatment Patterns will be summarized using descriptive statistics	Approximately 44 months
Primary	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	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
Secondary	Overall survival (OS)		Approximately 44 months
Secondary	Progression-free survival (PFS)		Approximately 44 months
Secondary	Objective response rate (ORR)		Approximately 44 months
Secondary	Mortality rate		Approximately 44 months
Secondary	Treatment-related adverse events (AEs) leading to discontinuation		Approximately 44 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls