NCT03658460

Immune Checkpoint Inhibitors in Advanced Non-small Cell Lung Cancer and Discovery of New Biomarkers

Immune Checkpoint Inhibitors in Advanced Non-Small Cell Lung Cancer and Discovery of New Biomarkers

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: Aalborg University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Lung cancer patients have a poor prognosis and only around 20 % is alive after 5 years. However, for advanced non-small cell lung cancer immunotherapy has become a cornerstone of treatment. Two immunotherapeutic drugs for lung cancer have been approved in the last two years. Immunotherapy blocks the capability of cancer cells to inactivate the patient´s immune system, thus re-enabling eradication of cancer cells. In clinical trials, immunotherapy has shown superior survival and less toxicity compared to standard chemotherapy. Whether the patients are candidates for immunotherapy or not is currently based on an unprecise biomarker that poorly predicts the patients who may benefit from immunotherapy. Immunotherapy can cause severe adverse effects and is expensive. Consequently, novel biomarkers are urgently needed from a patient perspective as well as a socioeconomic perspective. The objective of the project is to investigate changes in genes and other signals in tissue and blood samples from immunotherapy treated lung cancer patients. The investigators expect to identify new biomarkers that can predict with high precision, which patients may benefit from immunotherapy. On-treatment, the investigators also aim to identify biomarkers that predict the treatment response and reveal the underlying mechanisms when cancer cells become resistant to the treatment.

Conditions

• Non-small-cell Lung Cancer
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasm

Interventions

Type	Name	Description
OTHER	DNA sequencing	Targeted next generation sequencing and gene expression analysis with focus on immuno-oncology signatures

Timeline

• Start date: 2018-08-22
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2018-09-05
• Last updated: 2021-08-04

Locations

1 site across 1 country: Denmark