Non-small-cell Lung Cancer, Carcinoma, Non-Small-Cell Lung, Lung Neoplasm
Conditions
Keywords
immunotherapy, immune checkpoint inhibitors, biomarkers, sequencing
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.
Interventions
OTHERDNA sequencing
Targeted next generation sequencing and gene expression analysis with focus on immuno-oncology signatures
Sponsors
Aarhus University Hospital
Aalborg University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Denmark
Outcome results
None listed