Treatment Patterns in Advanced Small Cell Lung Cancer (SCLC)

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

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer

• Study Type: Observational
• Enrollment (Actual): 764

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08025
    • Local Institution
• United Kingdom
  • London, United Kingdom, N19JY
    • Local Institution

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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

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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2016
• Primary Completion (Actual): January 24, 2019
• Study Completion (Actual): January 24, 2019

Study Registration Dates

• First Submitted: October 13, 2017
• First Submitted That Met QC Criteria: February 1, 2018
• First Posted (Actual): February 8, 2018

Study Record Updates

• Last Update Posted (Actual): January 26, 2022
• Last Update Submitted That Met QC Criteria: January 11, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Small Cell Lung Cancer (SCLC)
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma
• Other Study ID Numbers: CA209-913