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

NCT04909164 | Active Not Recruiting

• 1 other identifier: 2021-02-015
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Non-small Cell Lung Cancer (NSCLC)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Response rate

  Up to 3 years

• Disease control rate

  Up to 3 years

• Duration of response

  Up to 3 years

• Hyper-progression

  Up to 3 years

Study Arms (4)

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

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

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

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

Interventions

Immunnotherapy group DRUG

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

Also known as: Cytotoxic chemotherapy group

1st- line Cytotoxic chemotherapy group(retrospective); 1st-line Immunotherapy group; 2nd-line Cytotoxic chemotherapy group; 2nd-line Immunotherapy group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

real-world lung cancer patients

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead
• National Evidence-Based Healthcare Collaborating Agency: collaborator

Study Sites (1)

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

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Myung-Ju Ahn, M.D, Ph.D.

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: June 1, 2021
• Study Start: June 15, 2021
• Primary Completion: July 30, 2025
• Study Completion: December 1, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)