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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03505515
• Other study ID #: CA209-693
• Status: Completed
• Start date: December 7, 2017
• Est. completion date: September 11, 2020

Study information

• Verified date: September 2021
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6205
• Est. completion date: September 11, 2020
• Est. primary completion date: September 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Non-small Cell Lung Cancer NSCLC
• Small Cell Lung Cancer SCLC
• Small Cell Lung Carcinoma

Locations

Country	Name	City	State
China	Local Institution	Shanghai	SHG

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants receiving first-line systemic therapy	Proportion of patients receiving first-line systemic anti-cancer treatment (chemotherapy, biologic/targeted therapy)	Approximately 36 months
Primary	Proportion of participants receiving second-line systemic therapy	Proportion of patients receiving second-line systemic anti-cancer treatment (chemotherapy, biologic/targeted therapy)	Approximately 36 months
Primary	Proportion of participants receiving third-line systemic therapy	Proportion of patients receiving third-line systemic anti-cancer treatment (chemotherapy, biologic/targeted therapy)	Approximately 36 months
Primary	Proportion of participants receiving fourth-line systemic therapy	Proportion of patients receiving fourth-line systemic anti-cancer treatment (chemotherapy, biologic/targeted therapy)	Approximately 36 months
Primary	Distribution of first-line regimens	All chemotherapy, radiation and/or biologic drugs given to a patient during the first 28 days after initiation of treatment	Approximately 36 months
Primary	Distribution of subsequent regimens	All chemotherapy, radiation and/or biologic drugs given to a patient following first-line regimen	Approximately 36 months
Primary	Distribution of first-line treatment duration	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	Approximately 36 months
Primary	Distribution of subsequent treatment duration	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	Approximately 36 months
Primary	Distribution of first-line therapy completion rate	Completion of more than 4 cycles	Approximately 36 months
Primary	Distribution of subsequent therapy completion rate	Completion of more than 4 cycles	Approximately 36 months
Secondary	Distribution of patient demographic data		At baseline
Secondary	Distribution of disease characteristic data		At baseline
Secondary	Distribution of Overall Survival from first observed diagnosis to death		At baseline
Secondary	Distribution of Overall Survival from the initiation of first-line systemic anti-cancer therapy to death		At baseline
Secondary	Distribution of Overall Survival from the initiation of second-line systemic anti-cancer therapy to death		At baseline
Secondary	Distribution of Overall Survival from the initiation of third-line systemic anti-cancer therapy to death		At baseline
Secondary	Distribution of Overall Survival from the initiation of fourth-line systemic anti-cancer therapy to death		At baseline
Secondary	Distribution of other cancer-directed therapies	Distribution of other cancer-directed therapies including surgery and radiation as well as supportive care	Approximately 36 months
Secondary	Distribution of Interval of Therapy		Up to 36 months
Secondary	Distribution of Lung Cancer related direct health care costs		Up to 36 months

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls