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

NCT03658460 | Completed DMC

• 1 other identifier: AaUH ONK 08-2018
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

immunotherapy; immune checkpoint inhibitors; biomarkers; sequencing

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

DNA sequencing OTHER

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

Also known as: Gene expression analysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Candidate for surgical and/or oncological treatment with curative intention
• Other synchronous cancer

Sponsors & Collaborators

• Aalborg University Hospital: lead
• Aarhus University Hospital: collaborator

Study Sites (1)

Dept. of Oncology, Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tissue and blod

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Sequence Analysis, DNA; Gene Expression Profiling

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Sequence Analysis; Genetic Techniques; Investigative Techniques

Study Officials

• Andreas Carus, MD, PhD

  Dept. of oncology, Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 29, 2018
• First Posted: September 5, 2018
• Study Start: August 22, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: August 4, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)