Long-term Epidemiological Follow-up of Non-small Cell Lung Cancer in Scandinavia

Completed

• Conditions: Non-Small Cell Lung Cancer

• Registration Number: NCT02839629
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

A study to describe and evaluate patient characteristics and clinical outcomes in Subjects with diagnosed Non Small Lung Cell Cancer in Sweden, Norway and Denmark.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-23
• Study First Submitted: 2016-07-12
• Study First Submitted QC: 2016-07-18
• Study First Posted: 2016-07-21
• Primary Completion: 2020-01-31
• Study Completion: 2021-05-07
• Status Verified: 2022-01
• Last Update Submitted: 2022-02-08
• Last Update Posted: 2022-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5657

Inclusion Criteria

Patients with a histologically confirmed diagnosis of NSCLC (squamous, adenocarcinoma, not otherwise specified NSCLC [NSCLC NOS]) identified in the Cancer registers

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Exclusion Criteria

• Age under 18 years at time of diagnosis

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression free survival based on Response Evaluation Criteria in Solid Tumors (RECIST)	Approximately 2 years	Progression free survival is defined as the time from date of treatment start to either the first disease progression date or last known tumor assessment date or death; Clinical outcomes will be assessed among NSCLC patients with advanced (stage IIIB and above) and earlier stage (stages I to IIIA) disease
Time to progression based on Response Evaluation Criteria in Solid Tumors (RECIST)	Approximately 2 years	Time to progression is defined as time from start of therapy until tumor progression; Clinical outcomes will be assessed among NSCLC patients with advanced (stage IIIB and above) and earlier stage (stages I to IIIA) disease
Partial Response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST)	Approximately 2 years	Partial response is defined as a record of at least a 30% decrease in the sum of diameters of target lesions, from the baseline sum; Clinical outcomes will be assessed among NSCLC patients with advanced (stage IIIB and above) and earlier stage (stages I to IIIA) disease
Percent of patients with an adverse event (AE)	Approximately 2 years	Patients with earlier stage (stages I to IIA) disease; AEs are defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product
Overall survival based on Response Evaluation Criteria in Solid Tumors (RECIST)	Approximately 2 years	Overall survival is defined as the time from start of treatment to the end of follow-up; Clinical outcomes will be assessed among NSCLC patients with advanced (stage IIIB and above) and earlier stage (stages I to IIIA) disease
Complete response based on Response Evaluation Criteria in Solid Tumors (RECIST)	Approximately 2 years	Complete response is defined as a record of disappearance of all target lesions; Clinical outcomes will be assessed among NSCLC patients with advanced (stage IIIB and above) and earlier stage (stages I to IIIA) disease
Disease control rate; defined as total number of patients whose Best Overall Response(BOR)= Complete Response(CR), Partial Response(PR) or Stable Disease(SD), divided by total number of patients	Approximately 2 years	Clinical outcomes will be assessed among NSCLC patients with advanced (stage IIIB and above) and earlier stage (stages I to IIIA) disease; BOR: Best Overall Response, CR: Complete Response, PR: Partial Response, SD: Stable Disease

Secondary Outcome Measures

Name	Time	Method
Drug utilization after NSCLC diagnosis by line of therapy	Approximately 2 years
Smoking habits of NSCLC patients at diagnosis	At baseline visit
Proportion of patients who receive surgery by stage at treatment	Approximately 2 years
Age of NSCLC patients at diagnosis	At baseline visit
Tumor node metastasis classification of NSCLC patients at diagnosis	At baseline visit
Charlson Comorbidity index of NSCLC patients at diagnosis	At baseline visit
Proportion of patients who receive radiation by stage at treatment	Approximately 2 years
Body Mass Index (BMI) of NSCLC patients at diagnosis	At baseline visit
NSCLC clinical subtype of NSCLC patients at diagnosis	At baseline visit