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Completed

NCT Number: NCT03505515

Treatment Patterns, Clinical Outcomes, and Healthcare Resource Utilization Associated With Chinese Patients With Advanced Lung Cancer

The purpose of the study is to document real-world pattern of care, outcomes and health resource use for participants diagnosed with and receiving treatment for advanced Non-small cell lung cancer (NSCLC) and extensive disease Small cell lung cancer (SCLC) in China.

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Key information

Conditions

Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Non-Small Cell Lung Cancer NSCLC Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Cancer SCLC Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Shanghai, SHG, 200031, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histologically confirmed advanced NSCLC (IIIB/IV) and extensive disease SCLC with pathology/cytology record between 1-Dec-2013 and 30-Nov-2014
  • Received inpatient treatment more than twice (inclusive) at a selected site. For hospitals with outpatient records, patients receiving oral TKI therapy and routinely (more than twice a year) followed up outpatient will be included although no inpatient records. For hospitals with outpatient chemotherapy center, patients will be include if they were prescribed with chemotherapy and routinely (more than twice a year, inclusive) followed up outpatient in the hospital
  • 18 years of age or older at initial diagnosis of IIIB/IV NSCLC and extensive disease SCLC

Exclusion criteria

  • Patients who have participated in or are attending clinical trials receiving active LC therapy
  • Unknown initial diagnosis time and initial treatment time.
  • For hospitals without outpatient chemo therapy center, patients who were prescribed with chemo therapy but with no inpatient records will be excluded
  • Patients who received inpatient therapy for one time and were not routinely (more than twice a year, inclusive) followed up outpatient will be excluded

Other protocol defined inclusion/exclusion criteria could apply

Treatment and study plan

Primary outcomes

  1. Proportion of participants receiving first-line systemic therapy

    Time frame: Approximately 36 months

    Proportion of patients receiving first-line systemic anti-cancer treatment (chemotherapy, biologic/targeted therapy)

  2. Proportion of participants receiving second-line systemic therapy

    Time frame: Approximately 36 months

    Proportion of patients receiving second-line systemic anti-cancer treatment (chemotherapy, biologic/targeted therapy)

  3. Proportion of participants receiving third-line systemic therapy

    Time frame: Approximately 36 months

    Proportion of patients receiving third-line systemic anti-cancer treatment (chemotherapy, biologic/targeted therapy)

  4. Proportion of participants receiving fourth-line systemic therapy

    Time frame: Approximately 36 months

    Proportion of patients receiving fourth-line systemic anti-cancer treatment (chemotherapy, biologic/targeted therapy)

  5. Distribution of first-line regimens

    Time frame: Approximately 36 months

    All chemotherapy, radiation and/or biologic drugs given to a patient during the first 28 days after initiation of treatment

  6. Distribution of subsequent regimens

    Time frame: Approximately 36 months

    All chemotherapy, radiation and/or biologic drugs given to a patient following first-line regimen

  7. Distribution of first-line treatment duration

    Time frame: Approximately 36 months

    Calculated by the difference between the treatment start date of the first observed drug in the regimen and the last observed date of the regimen

  8. Distribution of subsequent treatment duration

    Time frame: Approximately 36 months

    Calculated by the difference between the treatment start date of the first observed drug in the regimen and the last observed date of the regimen

  9. Distribution of first-line therapy completion rate

    Time frame: Approximately 36 months

    Completion of more than 4 cycles

  10. Distribution of subsequent therapy completion rate

    Time frame: Approximately 36 months

    Completion of more than 4 cycles

Secondary outcomes

  1. Distribution of patient demographic data

    Time frame: At baseline

  2. Distribution of disease characteristic data

    Time frame: At baseline

  3. Distribution of Overall Survival from first observed diagnosis to death

    Time frame: At baseline

  4. Distribution of Overall Survival from the initiation of first-line systemic anti-cancer therapy to death

    Time frame: At baseline

  5. Distribution of Overall Survival from the initiation of second-line systemic anti-cancer therapy to death

    Time frame: At baseline

  6. Distribution of Overall Survival from the initiation of third-line systemic anti-cancer therapy to death

    Time frame: At baseline

  7. Distribution of Overall Survival from the initiation of fourth-line systemic anti-cancer therapy to death

    Time frame: At baseline

  8. Distribution of other cancer-directed therapies

    Time frame: Approximately 36 months

    Distribution of other cancer-directed therapies including surgery and radiation as well as supportive care

  9. Distribution of Interval of Therapy

    Time frame: Up to 36 months

  10. Distribution of Lung Cancer related direct health care costs

    Time frame: Up to 36 months

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Treatment Patterns, Clinical Outcomes, and Healthcare Resource Utilization Associated With Chinese Patients With Advanced/Metastatic Lung Cancer: a Retrospective Observational Study

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Apr 23, 2018
Registry last updated
Sep 14, 2021

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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