Clinical trial · Observational
The Prospective Non-randomized Case-control Study From Real-world Lung Cancer Patients
The Pragmatic Clinical Trial to Elucidate Optimal Target Population of Immunotherapy From Real-world Lung Cancer Patients
NCT04909164CI-TRIAL-00126100OPTIMUScompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The pragmatic clinical trial to elucidate optimal target population of immunotherapy from real-world lung cancer patients
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer (NSCLC) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immunnotherapy group | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- 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
- interventionNames
- Drug: Immunnotherapy group
- label
- 2nd-line Cytotoxic chemotherapy group
- description
- Patients receiving reimbursed cytotoxic chemotherapy as second-line therapy after failure of platinum-based chemotherapy Drugs name : Docetaxel
- interventionNames
- Drug: Immunnotherapy group
- label
- 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
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDGo 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. PMID 42594970