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

Completed

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

• Registration Number: NCT03658460
• Lead Sponsor: Aalborg University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-22
• Study First Submitted: 2018-08-29
• Study First Submitted QC: 2018-09-03
• Study First Posted: 2018-09-05
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-01
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-03
• Last Update Posted: 2021-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Biopsy verified NSCLC
• ≥ 18 years
• WHO/ECOG performance status ≤ 2
• Measurable disease according to RECIST 1.1
• Candidate for immunotherapy treatment
• Understand and accept oral and written information
• Written informed consent

Exclusion Criteria

• Candidate for surgical and/or oncological treatment with curative intention
• Other synchronous cancer

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Predictive, prognostic and resistance signatures	Until progression or 1 year after immunotherapy start date	Next Generation Sequencing and gene expression analysis with NanoString PanCancer IO 360 panel in tissue samples at baseline and 1) at progression or 2) one year after immunotherapy start and no progression.

Trial Locations

Locations (1)

Dept. of Oncology, Aalborg University Hospital; 🇩🇰 Aalborg, Denmark