The Prospective Non-randomized Case-control Study From Real-world Lung Cancer Patients (OPTIMUS)

Samsung Medical Center

Status: Active, not recruiting

Conditions: Non-small Cell Lung Cancer (NSCLC)

Treatments: Drug: Immunnotherapy group

Study type: Observational

Funder types: Other

Identifiers

NCT04909164

2021-02-015

Details and patient eligibility

About

The pragmatic clinical trial to elucidate optimal target population of immunotherapy from real-world lung cancer patients

Full 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.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

1,500 participants in 4 patient groups

2nd-line Immunotherapy group

Description:

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

Treatment:

Drug: Immunnotherapy group

2nd-line Cytotoxic chemotherapy group

Description:

Patients receiving reimbursed cytotoxic chemotherapy as second-line therapy after failure of platinum-based chemotherapy Drugs name : Docetaxel

Treatment:

Drug: Immunnotherapy group

1st-line Immunotherapy group

Description:

First- line Control Arm: Retrospective hisrotical data of 680 cases to be collected Drugs name :Pembrolizumab only Pembrolizumab + Pemetrexed + Carboplatin Pembrolizumab + Paclitaxel + Carboplatin

Treatment:

Drug: Immunnotherapy group

1st- line Cytotoxic chemotherapy group(retrospective)

Description:

⦁ 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

Treatment:

Drug: Immunnotherapy group