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

NCT ID: NCT03658460

Last Updated: 2021-08-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-08-22
• Study Completion Date: 2019-12-01

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

DNA sequencing

Targeted next generation sequencing and gene expression analysis with focus on immuno-oncology signatures

Intervention Type: OTHER

Other Intervention Names

Gene expression analysis

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aarhus University Hospital

OTHER

Sponsor Role: collaborator

Aalborg University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Andreas Carus

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andreas Carus, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dept. of oncology, Aalborg University Hospital

Locations

Dept. of Oncology, Aalborg University Hospital

Aalborg, , Denmark

Countries

Denmark

Other Identifiers

AaUH ONK 08-2018

Identifier Type: -

Identifier Source: org_study_id