Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03505515
Recruitment Status : Recruiting
First Posted : April 23, 2018
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment
Lung Cancer Non-small Cell Lung Cancer NSCLC Small Cell Lung Cancer SCLC Other: Non-interventional

Layout table for study information
Study Type : Observational
Estimated Enrollment : 8800 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Treatment Patterns, Clinical Outcomes, and Healthcare Resource Utilization Associated With Chinese Patients With Advanced/Metastatic Lung Cancer: a Retrospective Observational Study
Actual Study Start Date : April 20, 2017
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Group/Cohort Intervention/treatment
Lung Cancer Patricipants in China
Participants with advanced/metastatic lung cancer (advanced NSCLC (IIIB/IV) and extensive disease SCLC) in China
Other: Non-interventional
Non-interventional




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Patients diagnosed with and receiving treatment for advanced NSCLC and extensive disease SCLC in China.
Criteria

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 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


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): NCT03505515


Contacts
Layout table for location contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

Locations
Layout table for location information
China, SHG
Local Institution Recruiting
Shanghai, SHG, China, 200031
Contact: Site 0001         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Layout table for investigator information
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03505515     History of Changes
Other Study ID Numbers: CA209-693
First Posted: April 23, 2018    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: June 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms