OPTIMUS: The Prospective Non-randomized Case-control Study From Real-world Lung Cancer Patients
Study Details
Study Description
Brief Summary
The prospective non-randomized case-control study to elucidate optimal target population of immunotherapy from real-world lung cancer patients
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Immunotherapy group Patients receiving reimbursed immunotherapy as a second-line therapy (in case of targeted therapy, patients receiving immunotherapy after targeted therapy-platinum-based chemotherapy) |
Drug: Immunnotherapy group
Eligible patients are those who receive reimbursed immunotherapy or cytotoxic chemotherapy after failure of platinum-based chemotherapy per current health insurance reimbursement criteria.
Other Names:
|
| Cytotoxic chemotherapy group Patients receiving reimbursed cytotoxic chemotherapy as second-line therapy after failure of platinum-based chemotherapy |
Drug: Immunnotherapy group
Eligible patients are those who receive reimbursed immunotherapy or cytotoxic chemotherapy after failure of platinum-based chemotherapy per current health insurance reimbursement criteria.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Progression-free survival [Up to 3 years]
The time from first dose to disease progression or death from any cause
- Overall-survival [Up to 3 years]
The time from first dose to death from any cause
Secondary Outcome Measures
- Response rate [Up to 3 years]
The proportion of patients showing complete or partial response as determined by RECIST v1.1
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
[Immunotherapy group]
-
Male and female patients must be at least 19 years of age.
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Patients with histologically confirmed NSCLC
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Patients on palliative therapy for recurrence after surgery or de novo advanced and metastatic disease
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Patients receiving reimbursed immunotherapy as a second-line therapy (in case of targeted therapy, patients receiving immunotherapy after targeted therapy-platinum-based chemotherapy)
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Patients who provided written informed consent for the study (including the secondary use of the study data and sharing with third parties) [Cytotoxic chemotherapy group]
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Male and female patients must be at least 19 years of age.
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Patients with histologically confirmed NSCLC
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Patients on palliative therapy for recurrence after surgery or de novo advanced and metastatic disease
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Patients receiving reimbursed cytotoxic chemotherapy as second-line therapy after failure of platinum-based chemotherapy
-
Patients who provided written informed consent for the study (including the secondary use of the study data and sharing with third parties)
Exclusion Criteria:
[Immunotherapy group]
-
Patients receiving immunotherapy without reimbursement
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Patients who do not provide consent to the study [Cytotoxic chemotherapy group]
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Patients receiving cytotoxic chemotherapy without reimbursement
-
Patients who do not provide consent to the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine | Seoul | Korea, Republic of | 135-710 |
Sponsors and Collaborators
- Samsung Medical Center
- National Evidence-Based Healthcare Collaborating Agency
Investigators
- Principal Investigator: Myung-Ju Ahn, M.D, Ph.D., Samsung Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021-02-015