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

Carcinoma, Non-Small-Cell Lung Clinical Trial

— LimBio  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03658460
• Other study ID #: AaUH ONK 08-2018
• Status: Completed
• Start date: August 22, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: August 2021
• Source: Aalborg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• DNA sequencing
Targeted next generation sequencing and gene expression analysis with focus on immuno-oncology signatures

Locations

Country	Name	City	State
Denmark	Dept. of Oncology, Aalborg University Hospital	Aalborg

Sponsors (2)

Lead Sponsor	Collaborator
Aalborg University Hospital	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predictive, prognostic and resistance signatures	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.	Until progression or 1 year after immunotherapy start date