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

Non-small Cell Lung Cancer (NSCLC) Clinical Trial

— OPTIMUS  

Official title:

The Prospective Non-randomized Case-control Study to Elucidate Optimal Target Population of Immunotherapy From Real-world Lung Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04909164
• Other study ID #: 2021-02-015
• Status: Recruiting
• Start date: June 15, 2021
• Est. completion date: June 1, 2024

Study information

• Verified date: August 2021
• Source: Samsung Medical Center
• Contact: Myung-Ju Ahn, M.D, Ph.D.
• Phone: +82-70-7014-4178
• Email: silk.ahn[@]samsung.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The prospective non-randomized case-control study to elucidate optimal target population of immunotherapy from real-world lung cancer patients

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 information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

[Immunotherapy group]

• Male and female patients must be at least 19 years of age.

• 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 a second-line therapy (in case of targeted therapy, patients receiving immunotherapy after targeted therapy-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) [Cytotoxic chemotherapy group]

• Male and female patients must be at least 19 years of age.

• Patients with histologically confirmed NSCLC

• Patients on palliative therapy for recurrence after surgery or de novo advanced and metastatic disease

• 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

• Patients who do not provide consent to the study [Cytotoxic chemotherapy group]

• Patients receiving cytotoxic chemotherapy without reimbursement

• Patients who do not provide consent to the study

Related Conditions & MeSH terms

• Lung Neoplasms
• Non-small Cell Lung Cancer (NSCLC)

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Medical Center	National Evidence-Based Healthcare Collaborating Agency

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival	The time from first dose to disease progression or death from any cause	Up to 3 years
Primary	Overall-survival	The time from first dose to death from any cause	Up to 3 years
Secondary	Response rate	The proportion of patients showing complete or partial response as determined by RECIST v1.1	Up to 3 years
Secondary	Disease control rate	The proportion or patients showing complete or partial response or stable disease as determined by RECIST v1.1.	Up to 3 years
Secondary	Duration of response	The duration of response in patients showing complete or partial response	Up to 3 years
Secondary	Hyper-progression	The proportion of patients showing hyper-progression after prior treatment according to the criterion for hyper-progression, their survival rate, and predictors of survival	Up to 3 years