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Completed

NCT Number: NCT03425825

Treatment Patterns in Advanced Small Cell Lung Cancer (SCLC)

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.

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Key information

Conditions

Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Feb 8, 2018
Registry last updated
Jan 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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