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

Study Overview
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Brief Summary
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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.

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

Conditions
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Lung Cancer, Non-small Cell Lung Cancer NSCLC, Small Cell Lung Cancer SCLC

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lung Cancer Patricipants in China<br>Participants with advanced/metastatic lung cancer (advanced NSCLC (IIIB/IV) and extensive disease SCLC) in China | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Distribution of subsequent regimens | All chemotherapy, radiation and/or biologic drugs given to a patient following first-line regimen | Approximately 36 months | 
| 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 | 
| 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 | 
| Distribution of first-line therapy completion rate | Completion of more than 4 cycles | Approximately 36 months | 
| Distribution of subsequent therapy completion rate | Completion of more than 4 cycles | Approximately 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of patient demographic data |  | At baseline | 
| Distribution of disease characteristic data |  | At baseline | 
| Distribution of Overall Survival from first observed diagnosis to death |  | 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 third-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 | 
| Distribution of other cancer-directed therapies | Distribution of other cancer-directed therapies including surgery and radiation as well as supportive care | Approximately 36 months | 
| Distribution of Interval of Therapy |  | Up to 36 months | 
| Distribution of Lung Cancer related direct health care costs |  | Up to 36 months |