The Prospective Non-randomized Case-control Study From Real-world Lung Cancer Patients
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Interventions
- Drug: Immunnotherapy group
- Registration Number
- NCT04909164
- Lead Sponsor
- Samsung Medical Center
- 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 will not provide any additional intervention to patients, but they will receive all treatments available per standard of care at each institution. If the reimbursement criteria change or expand (to include the immunotherapy as the first-line therapy) in the future, patients who get to receive immunotherapy or cytotoxic chemotherapy according to the revised and expanded reimbursement criteria will be enrolled as well.
Because immunotherapy was superior to the existing cytotoxic chemotherapy in terms of survival and AEs in previous large-scale prospective studies, immunotherapy has been preferred than cytotoxic chemotherapy after failure of platinum-based chemotherapy in real-world clinical settings. In addition, pembrolizumab and nivolumab are reimbursed according to PD-L1 expression levels, but atezolizumab is reimbursed for all patients regardless of PD-L1 expression levels and thus is available for reimbursed prescription for practically every patient. These three agents showed almost no difference in their clinical effectiveness in previous prospective global studies. However, cytotoxic chemotherapy is selected over immunotherapy in some patients, and they will be assigned to the control group.
Based on the patient's symptoms and the physician's clinical judgment, cytotoxic therapy can be selected as a second-line therapy in clinical settings if the patient has an extensive lesion that requires inducing a rapid response or has experienced a disease progression centered on bone or liver metastases, which are known to respond only marginally to immunotherapy.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1500
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 2nd-line Immunotherapy group Immunnotherapy group Patients receiving reimbursed immunotherapy as a second-line therapy (in case of targeted therapy, patients receiving immunotherapy after targeted therapy-platinum-based chemotherapy) Drugs name : Pembrolizumab, Atezolizumab ,Nivolumab 2nd-line Cytotoxic chemotherapy group Immunnotherapy group Patients receiving reimbursed cytotoxic chemotherapy as second-line therapy after failure of platinum-based chemotherapy Drugs name : Docetaxel 1st-line Immunotherapy group Immunnotherapy group First- line Control Arm: Retrospective hisrotical data of 680 cases to be collected Drugs name :Pembrolizumab only Pembrolizumab + Pemetrexed + Carboplatin Pembrolizumab + Paclitaxel + Carboplatin 1st- line Cytotoxic chemotherapy group(retrospective) Immunnotherapy group ⦁ 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. Drugs name : Pemetrexed + Cisplatin/Carboplatin Gemcitabine + Cisplatin/Carboplatin
- Primary Outcome Measures
Name Time Method Overall-survival Up to 3 years The time from first dose to death from any cause
Progression-free survival Up to 3 years The time from first dose to disease progression or death from any cause
- Secondary Outcome Measures
Name Time Method Disease control rate Up to 3 years The proportion or patients showing complete or partial response or stable disease as determined by RECIST v1.1.
Duration of response Up to 3 years The duration of response in patients showing complete or partial response
Hyper-progression Up to 3 years The proportion of patients showing hyper-progression after prior treatment according to the criterion for hyper-progression, their survival rate, and predictors of survival
Response rate Up to 3 years The proportion of patients showing complete or partial response as determined by RECIST v1.1
Trial Locations
- Locations (1)
Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
🇰🇷Seoul, Korea, Republic of