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

The Pragmatic Clinical Trial to Elucidate Optimal Target Population of Immunotherapy From Real-world Lung Cancer Patients

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

Study Overview

• Status: Active, not recruiting
• Conditions: Non-small Cell Lung Cancer (NSCLC)
• Intervention / Treatment: Drug: Immunnotherapy group

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 Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

real-world lung cancer patients

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
2nd-line 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) Drugs name : Pembrolizumab, Atezolizumab ,Nivolumab	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
2nd-line Cytotoxic chemotherapy group; Patients receiving reimbursed cytotoxic chemotherapy as second-line therapy after failure of platinum-based chemotherapy Drugs name : Docetaxel	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
1st-line Immunotherapy group; First- line Control Arm: Retrospective hisrotical data of 680 cases to be collected Drugs name :Pembrolizumab only Pembrolizumab + Pemetrexed + Carboplatin Pembrolizumab + Paclitaxel + Carboplatin	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
1st- line Cytotoxic chemotherapy group(retrospective); ⦁ 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival	The time from first dose to disease progression or death from any cause	Up to 3 years
Overall-survival	The time from first dose to death from any cause	Up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response rate	The proportion of patients showing complete or partial response as determined by RECIST v1.1	Up to 3 years
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
Duration of response	The duration of response in patients showing complete or partial response	Up to 3 years
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

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Collaborators: National Evidence-Based Healthcare Collaborating Agency
• Investigators: Principal Investigator: Myung-Ju Ahn, M.D, Ph.D., Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2021
• Primary Completion (Estimated): July 30, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: May 26, 2021
• First Submitted That Met QC Criteria: May 26, 2021
• First Posted (Actual): June 1, 2021

Study Record Updates

• Last Update Posted (Actual): May 16, 2025
• Last Update Submitted That Met QC Criteria: May 13, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 2021-02-015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No