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

Completed

• Conditions: Non-small Cell Lung Cancer NSCLC; Small Cell Lung Cancer SCLC; Lung Cancer

• Registration Number: NCT03505515
• Lead Sponsor: Bristol-Myers Squibb

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-12-07
• Study First Submitted: 2018-04-06
• Study First Submitted QC: 2018-04-12
• Study First Posted: 2018-04-23
• Primary Completion: 2020-09-11
• Study Completion: 2020-09-11
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-07
• Last Update Posted: 2021-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6205

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Distribution of first-line treatment duration	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
Proportion of participants receiving fourth-line systemic therapy	Approximately 36 months	Proportion of patients receiving fourth-line systemic anti-cancer treatment (chemotherapy, biologic/targeted therapy)
Proportion of participants receiving first-line systemic therapy	Approximately 36 months	Proportion of patients receiving first-line systemic anti-cancer treatment (chemotherapy, biologic/targeted therapy)
Proportion of participants receiving second-line systemic therapy	Approximately 36 months	Proportion of patients receiving second-line systemic anti-cancer treatment (chemotherapy, biologic/targeted therapy)
Distribution of subsequent regimens	Approximately 36 months	All chemotherapy, radiation and/or biologic drugs given to a patient following first-line regimen
Distribution of first-line therapy completion rate	Approximately 36 months	Completion of more than 4 cycles
Distribution of subsequent therapy completion rate	Approximately 36 months	Completion of more than 4 cycles
Proportion of participants receiving third-line systemic therapy	Approximately 36 months	Proportion of patients receiving third-line systemic anti-cancer treatment (chemotherapy, biologic/targeted therapy)
Distribution of first-line regimens	Approximately 36 months	All chemotherapy, radiation and/or biologic drugs given to a patient during the first 28 days after initiation of treatment
Distribution of subsequent treatment duration	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

Secondary Outcome Measures

Name	Time	Method
Distribution of disease characteristic data	At baseline
Distribution of Overall Survival from first observed diagnosis to death	At baseline
Distribution of other cancer-directed therapies	Approximately 36 months	Distribution of other cancer-directed therapies including surgery and radiation as well as supportive care
Distribution of Interval of Therapy	Up to 36 months
Distribution of Lung Cancer related direct health care costs	Up to 36 months
Distribution of Overall Survival from the initiation of third-line systemic anti-cancer therapy to death	At baseline
Distribution of patient demographic data	At baseline
Distribution of Overall Survival from the initiation of first-line systemic anti-cancer therapy to death	At baseline
Distribution of Overall Survival from the initiation of second-line systemic anti-cancer therapy to death	At baseline
Distribution of Overall Survival from the initiation of fourth-line systemic anti-cancer therapy to death	At baseline

Trial Locations

Locations (1)

Local Institution; 🇨🇳 Shanghai, SHG, China