Treatment Patterns in Advanced Small Cell Lung Cancer (SCLC)

NCT03425825 | Completed

• 1 other identifier: CA209-913
• Study Type: observational
• Target: 764
• Locations: 2 countries
• Sites: 2

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.

Conditions

Lung Cancer

Keywords

Small Cell Lung Cancer (SCLC)

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (10)

• Composite of SCLC-related healthcare resource utilization (HCRU)

  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

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Advanced SCLC patients in 4 European countries (France, Germany, Italy, and United Kingdom \[UK\]).

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (2)

Local Institution

Barcelona, 08025, Spain

Location

Local Institution

London, N19JY, United Kingdom

Location

Related Links

• BMS Clinical Trial Information
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Lung Neoplasms; Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2017
• First Posted: February 8, 2018
• Study Start: December 15, 2016
• Primary Completion: January 24, 2019
• Study Completion: January 24, 2019
• Last Updated: January 26, 2022

Record last verified: 2022-01

Locations

GB (1); ES (1)