Clinical trial NCT03658460: Immune Checkpoint Inhibitors in Advanced Non-small Cell Lung Cancer and Discovery of New Biomarkers
Official title: Immune Checkpoint Inhibitors in Advanced Non-Small Cell Lung Cancer and Discovery of New Biomarkers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small-cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Lung Neoplasm
Keywords: immunotherapy
immune checkpoint inhibitors
biomarkers
sequencing
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2018-09-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Around 100 patients with advanced NSCLC, who meet the inclusion criteria, are consecutively included in the study. The outpatient clinic at the Departments of Oncology, Aalborg University Hospital and Aarhus University Hospital recruit and include the patients. Patients are candidates to the LimBio protocol regardless of immunotherapy treatment line.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Predictive, prognostic and resistance signatures
timeFrame: Until progression or 1 year after immunotherapy start date
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Dept. of Oncology, Aalborg University Hospital
Study officials:
affiliation: Dept. of oncology, Aalborg University Hospital
name: Andreas Carus, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: