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Non-small Cell Lung Cancer (NSCLC)OPTIMUSNCT04909164

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

An observational study of Non-small Cell Lung Cancer (NSCLC), run by Myung-Ju Ahn at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The pragmatic clinical trial to elucidate optimal target population of immunotherapy from real-world lung cancer patients Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Non-small Cell Lung Cancer (NSCLC)
What is being tested?
Immunnotherapy group
How many people
1,519 participants
Where
1 siteSouth Korea
Study dates
15 Jun 2021to 30 Jul 2026
How long will I take part?
3 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: real-world lung cancer patients

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 locations and contacts

1 site in 1 country.

South Korea1 site

  • Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine

    Seoul, 135-710

Other trials in South Korea

About this study

Official title: 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

Read the 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.

Being tested
Immunnotherapy group
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Immunnotherapy groupDrug

    Also called Cytotoxic chemotherapy group

    Eligible patients are those who receive reimbursed immunotherapy or cytotoxic chemotherapy after failure of platinum-based chemotherapy per current health insurance reimbursement criteria.

Study groups in NCT04909164
Study groupRoleWhat they receive
2nd-line Immunotherapy groupPatients 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
Receives: Drug: Immunnotherapy group
2nd-line Cytotoxic chemotherapy groupPatients receiving reimbursed cytotoxic chemotherapy as second-line therapy after failure of platinum-based chemotherapy Drugs name : Docetaxel
Receives: Drug: Immunnotherapy group
1st-line Immunotherapy groupFirst- line Control Arm: Retrospective hisrotical data of 680 cases to be collected Drugs name :Pembrolizumab only Pembrolizumab + Pemetrexed + Carboplatin Pembrolizumab + Paclitaxel + Carboplatin
Receives: Drug: Immunnotherapy 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
Receives: Drug: Immunnotherapy group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival

    The time from first dose to disease progression or death from any cause

    Measured: Up to 3 years

  2. Overall-survival

    The time from first dose to death from any cause

    Measured: Up to 3 years

Secondary outcomes (4)

  1. Response rate

    The proportion of patients showing complete or partial response as determined by RECIST v1.1

    Measured: Up to 3 years

  2. Disease control rate

    The proportion or patients showing complete or partial response or stable disease as determined by RECIST v1.1.

    Measured: Up to 3 years

  3. Duration of response

    The duration of response in patients showing complete or partial response

    Measured: Up to 3 years

  4. 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

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2021
  2. Study start15 Jun 2021
  3. Primary completion31 Dec 2025
  4. Study completion30 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Other
Enrolment
1,519 participants (actual)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04909164
Sponsor's protocol ID
2021-02-015
Acronym
OPTIMUS
Status last verified
Sep 2026
First submitted
26 May 2021
Last updated
4 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Go SI, Kim J, Park S, Kim IH, Kim DW, Lee YG, Cho JH, Cho EK, Lee HW, Park JH, Kang EJ, Lee Y, Son NH, Gwon SH, Jung HA, Sun JM, Lee SH, Ahn JS, Ahn MJ, Lee GW. Early On-Treatment Host Fitness Dynamics Refine Prognostic Stratification in Advanced NSCLC Receiving First-Line Immunotherapy. Cancer Res Treat. 2026 Aug 10. doi: 10.4143/crt.2026.0607. Online ahead of print.

    PubMed 42594970

Questions about this trial

What is this clinical trial studying?

An observational study of Non-small Cell Lung Cancer (NSCLC), run by Myung-Ju Ahn at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (time frame: Up to 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04909164, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.

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