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PD-1 Immune Checkpoint Inhibitors and Immune-Related Adverse Events: a Cohort Study

NCT04115410 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 4724

Last updated 2020-05-28

No results posted yet for this study

Summary

The objective of our study is to assess the risk of immune-related adverse events associated with PD-1 inhibitors use compared to standard chemotherapy use in patients with non small cell lung cancer, using nationwide healthcare database.

Conditions

  • Carcinoma, Non-Small-Cell Lung
  • Immune-Related Adverse Events

Interventions

DRUG

PD-1 inhibitor

PD-1 inhibitors are a group of checkpoint inhibitors being developed for the treatment of cancer. PD-1 and PD-L1 are both proteins present on the surface of cells. Immune checkpoint inhibitors such as these are emerging as a front-line treatment for several types of cancer. The investigators will include nivolumab, pembrolizumab, and atezolizumab as PD-1 inhibitors as these drugs are reimbursed by health authority of South Korea.

DRUG

Chemotherapy Drugs, Cancer

Chemotherapy is a type of pharmacotherapy for cancer, that uses one or more anti-cancer drugs as part of a standardized chemotherapy regimen. The investigators will include cytotoxic chemotherapy and tyrosine kinase inhibitors (epidermal growth cell receptor (EGFR) and anaplastic lymphoma kinase (ALK) inhibitors).

Sponsors & Collaborators

  • Ministry of Food and Drug Safety, Korea

    collaborator OTHER_GOV

  • Sungkyunkwan University

    lead OTHER

Principal Investigators

  • Ju-Young Shin, PhD · Sungkyunkwan University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2021-09-23
Completion
2021-12-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04115410 on ClinicalTrials.gov