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

A

Aalborg University Hospital

Status

Completed

Conditions

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

Treatments

Other: DNA sequencing

Study type

Observational

Funder types

Other

Identifiers

NCT03658460
AaUH ONK 08-2018

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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