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Treatment Patterns in Advanced Small Cell Lung Cancer (SCLC)

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ClinicalTrials.gov Identifier: NCT03425825
Recruitment Status : Completed
First Posted : February 8, 2018
Last Update Posted : January 26, 2022
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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.

Condition or disease
Lung Cancer

Study Design
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Study Type : Observational
Actual Enrollment : 764 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Treatment Patterns Among Patients With Advanced Small Cell Lung Cancer (SCLC) in Europe
Actual Study Start Date : December 15, 2016
Actual Primary Completion Date : January 24, 2019
Actual Study Completion Date : January 24, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Distribution of Patient Demographic Characteristics [ Time Frame: At baseline ]

    Characteristics include:

    Age/month and year of birth Gender Ethnicity Weight Height Smoking status Alcohol consumption Other relevant risk factors


  2. Distribution of Patient Clinical Characteristics in Relapsed/refractory patients receiving second- or later-line treatment [ Time Frame: At baseline ]

    Characteristics include:

    Relevant comorbidities Laboratory parameters Date of initial diagnosis Staging using the VALG system Histology ECOG Performance status Tumor status Symptoms


  3. Distribution of Patient Clinical Characteristics in patients with LD-SCLC [ Time Frame: At baseline ]

    Characteristics include:

    Relevant comorbidities Laboratory parameters Date of initial diagnosis Staging using the VALG system Histology ECOG Performance status Tumor status Symptoms


  4. Distribution of Patient Clinical Characteristics in patients with ED-SCLC [ Time Frame: At baseline ]

    Characteristics include:

    Relevant comorbidities Laboratory parameters Date of initial diagnosis Staging using the VALG system Histology ECOG Performance status Tumor status Symptoms


  5. Distribution of treatment patterns in patients with ED-SCLC [ Time Frame: Approximately 44 months ]
    Details on patients prior treatment Patterns will be summarized using descriptive statistics

  6. Distribution of treatment patterns in patients with LD-SCLC [ Time Frame: Approximately 44 months ]
    Details on patients prior treatment Patterns will be summarized using descriptive statistics

  7. Distribution of treatment patterns in Relapsed/refractory patients receiving second- or later-line treatment [ Time Frame: Approximately 44 months ]
    Details on patients prior treatment Patterns will be summarized using descriptive statistics


Secondary Outcome Measures :
  1. Composite of SCLC-related healthcare resource utilization (HCRU) [ Time Frame: 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.

  2. Overall survival (OS) [ Time Frame: Approximately 44 months ]
  3. Progression-free survival (PFS) [ Time Frame: Approximately 44 months ]
  4. Objective response rate (ORR) [ Time Frame: Approximately 44 months ]
  5. Mortality rate [ Time Frame: Approximately 44 months ]
  6. Treatment-related adverse events (AEs) leading to discontinuation [ Time Frame: Approximately 44 months ]
  7. Incidence of surgery as cancer-directed therapy [ Time Frame: Approximately 44 months ]
    To describe the use of surgery in the management of LD-SCLC and ED-SCLC patients having relapsed

  8. Incidence of radiation therapy as cancer-directed therapy [ Time Frame: Approximately 44 months ]
    To describe the use of radiation therapy in the management of LD-SCLC and ED-SCLC patients having relapsed

  9. Incidence of best supportive care (BSC) [ Time Frame: Approximately 44 months ]
    To describe the use of best supportive care (BSC) in the management of LD-SCLC and ED-SCLC patients having relapsed

  10. Incidence of palliative care [ Time Frame: Approximately 44 months ]
    To describe the use of palliative care in the management of LD-SCLC and ED-SCLC patients having relapsed


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Advanced SCLC patients in 4 European countries (France, Germany, Italy, and United Kingdom [UK]).
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03425825


Locations
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Spain
Local Institution
Barcelona, Spain, 08025
United Kingdom
Local Institution
London, United Kingdom, N19JY
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03425825    
Other Study ID Numbers: CA209-913
First Posted: February 8, 2018    Key Record Dates
Last Update Posted: January 26, 2022
Last Verified: January 2022
Keywords provided by Bristol-Myers Squibb:
Small Cell Lung Cancer (SCLC)
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms