Treatment Patterns in Advanced Small Cell Lung Cancer (SCLC)

Completed

• Conditions: Lung Cancer

• Registration Number: NCT03425825
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-12-15
• Study First Submitted: 2017-10-13
• Study First Submitted QC: 2018-02-01
• Study First Posted: 2018-02-08
• Primary Completion: 2019-01-24
• Study Completion: 2019-01-24
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-11
• Last Update Posted: 2022-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 764

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)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 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
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 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 treatment patterns in patients with ED-SCLC	Approximately 44 months	Details on patients prior treatment Patterns will be summarized using descriptive statistics

Secondary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	Approximately 44 months
Objective response rate (ORR)	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 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
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.
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
Overall survival (OS)	Approximately 44 months
Mortality rate	Approximately 44 months
Treatment-related adverse events (AEs) leading to discontinuation	Approximately 44 months

Trial Locations

Locations (1)

Local Institution; 🇬🇧 London, United Kingdom