Clinical trial NCT03505515: Treatment Patterns, Clinical Outcomes, and Healthcare Resource Utilization Associated With Chinese Patients With Advanced Lung Cancer
Official title: Treatment Patterns, Clinical Outcomes, and Healthcare Resource Utilization Associated With Chinese Patients With Advanced/Metastatic Lung Cancer: a Retrospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Non-small Cell Lung Cancer NSCLC
Small Cell Lung Cancer SCLC
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-04-23
Enrollment: 6205
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with and receiving treatment for advanced NSCLC and extensive disease SCLC in China.

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.


Eligibility 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 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

Primary outcomes:
measure: Proportion of participants receiving first-line systemic therapy
timeFrame: Approximately 36 months
measure: Proportion of participants receiving second-line systemic therapy
timeFrame: Approximately 36 months
measure: Proportion of participants receiving third-line systemic therapy
timeFrame: Approximately 36 months
measure: Proportion of participants receiving fourth-line systemic therapy
timeFrame: Approximately 36 months
measure: Distribution of first-line regimens
timeFrame: Approximately 36 months
measure: Distribution of subsequent regimens
timeFrame: Approximately 36 months
measure: Distribution of first-line treatment duration
timeFrame: Approximately 36 months
measure: Distribution of subsequent treatment duration
timeFrame: Approximately 36 months
measure: Distribution of first-line therapy completion rate
timeFrame: Approximately 36 months
measure: Distribution of subsequent therapy completion rate
timeFrame: Approximately 36 months
Secondary outcomes:
measure: Distribution of patient demographic data
timeFrame: At baseline
measure: Distribution of disease characteristic data
timeFrame: At baseline
measure: Distribution of Overall Survival from first observed diagnosis to death
timeFrame: At baseline
measure: Distribution of Overall Survival from the initiation of first-line systemic anti-cancer therapy to death
timeFrame: At baseline
measure: Distribution of Overall Survival from the initiation of second-line systemic anti-cancer therapy to death
timeFrame: At baseline
measure: Distribution of Overall Survival from the initiation of third-line systemic anti-cancer therapy to death
timeFrame: At baseline
measure: Distribution of Overall Survival from the initiation of fourth-line systemic anti-cancer therapy to death
timeFrame: At baseline
measure: Distribution of other cancer-directed therapies
timeFrame: Approximately 36 months
measure: Distribution of Interval of Therapy
timeFrame: Up to 36 months
measure: Distribution of Lung Cancer related direct health care costs
timeFrame: Up to 36 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Local Institution
state: SHG
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Qiu B, Li G, Luo F, Cai X, Wu L, Chen J, Hu Y, Tang Z, Yang S, He J. Treatment patterns, clinical outcomes, and healthcare resource use associated with advanced/metastatic lung cancer in China: protocol for a retrospective observational study. Transl Lung Cancer Res. 2020 Dec;9(6):2460-2468. doi: 10.21037/tlcr-20-1269.