Status:
ACTIVE_NOT_RECRUITING
The Prospective Non-randomized Case-control Study From Real-world Lung Cancer Patients
Lead Sponsor:
Samsung Medical Center
Collaborating Sponsors:
National Evidence-Based Healthcare Collaborating Agency
Conditions:
Non-small Cell Lung Cancer (NSCLC)
Eligibility:
All Genders
19+ years
Brief Summary
The pragmatic clinical trial to elucidate optimal target population of immunotherapy from real-world lung cancer patients
Detailed Description
Eligible patients are those who receive reimbursed immunotherapy or cytotoxic chemotherapy after failure of platinum-based chemotherapy per current health insurance reimbursement criteria. This study ...
Eligibility Criteria
Inclusion
- 7-1 Inclusion criteria 7-1-1 Immunotherapy arm (prospective data collection)
- Male and female patients aged 19 years and above
- Patients with histologically confirmed NSCLC
- Patients on palliative therapy for recurrence after surgery or de novo advanced and metastatic disease
- Patients receiving reimbursed immunotherapy as second-line therapy (in case of targeted therapy, patients receiving immunotherapy after targeted therapy-platinum-based chemotherapy) or as reimbursed first-line therapy
- Patients who provided written informed consent for the study (including the secondary use of the study data and sharing with third parties) 7-1-2 Cytotoxic chemotherapy arm (prospective/retrospective data collection)
- Male and female patients aged 19 years and above
- Patients with histologically confirmed NSCLC
- Patients on palliative therapy for recurrence after surgery or de novo advanced and metastatic disease
- Prospective: Patients receiving reimbursed cytotoxic chemotherapy as second-line therapy after failure of platinum-based chemotherapy
- Retrospective: In addition to the prospective data, retrospective data will be collected from medical records of 680 patients (or more) who had records of receiving cytotoxic chemotherapy between January 1, 2017, and December 31, 2018 (1:1 comparison between the immunotherapy arm and the chemotherapy arm). If the patient did not die within the first 12 months after diagnosis, available follow-up data of at least 12 months will be collected from the medical records of the participating institution.Patients who provided written informed consent for the study (including the secondary use of the study data and sharing with third parties) 7-2 Exclusion criteria 7-2-1 Immunochemotherapy arm
- Patients receiving immunotherapy without reimbursement
- Patients who do not provide consent to the study 7-2-2 Cytotoxic chemotherapy arm
- Patients receiving cytotoxic chemotherapy without reimbursement
- Patients who do not provide consent to the study
Exclusion
Key Trial Info
Start Date :
June 15 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT04909164
Start Date
June 15 2021
End Date
December 1 2025
Last Update
May 16 2025
Active Locations (1)
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1
Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, South Korea, 135-710