Non-Small Cell Lung Cancer
Conditions
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.
Interventions
None listed
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with a histologically confirmed diagnosis of NSCLC (squamous, adenocarcinoma, not otherwise specified NSCLC \[NSCLC NOS\]) identified in the Cancer registers
Exclusion criteria
* Age under 18 years at time of diagnosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Percent of patients with an adverse event (AE) | Approximately 2 years | Patients with advanced stage (stage IIIB and above) 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 |
Secondary
| Measure | Time frame |
|---|---|
| Age of NSCLC patients at diagnosis | At baseline visit |
| Tumor node metastasis classification of NSCLC patients at diagnosis | At baseline visit |
| NSCLC clinical subtype of NSCLC patients at diagnosis | At baseline visit |
| Charlson Comorbidity index of NSCLC patients at diagnosis | At baseline visit |
| Drug utilization after NSCLC diagnosis by line of therapy | Approximately 2 years |
| Proportion of patients who receive surgery by stage at treatment | Approximately 2 years |
| 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 |
| Smoking habits of NSCLC patients at diagnosis | At baseline visit |
Outcome results
None listed