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

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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 6205

Contacts and Locations

Study Locations

• China
  • SHG
    • Shanghai, SHG, China, 200031
      • Local Institution

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with and receiving treatment for advanced NSCLC and extensive disease SCLC in China.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Lung Cancer Patricipants in China; Participants with advanced/metastatic lung cancer (advanced NSCLC (IIIB/IV) and extensive disease SCLC) in China

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

General Publications

• 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.

Helpful Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2017
• Primary Completion (Actual): September 11, 2020
• Study Completion (Actual): September 11, 2020

Study Registration Dates

• First Submitted: April 6, 2018
• First Submitted That Met QC Criteria: April 12, 2018
• First Posted (Actual): April 23, 2018

Study Record Updates

• Last Update Posted (Actual): September 14, 2021
• Last Update Submitted That Met QC Criteria: September 7, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma
• Other Study ID Numbers: CA209-693

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No