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

• Sponsor: Aalborg University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03658460
• Collaborator: Aarhus University Hospital (Other)
• Enrollment: 60
• Location: 1
• Actual Duration (Months): 15.3
• Patients Per Site Per Month: 3.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-small-cell Lung Cancer; Carcinoma, Non-Small-Cell Lung; Lung Neoplasm	Other: DNA sequencing

Study Design

• Study Type: Observational
• Actual Enrollment: 60 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Immune Checkpoint Inhibitors in Advanced Non-Small Cell Lung Cancer and Discovery of New Biomarkers
• Actual Study Start Date: Aug 22, 2018
• Actual Primary Completion Date: Dec 1, 2019
• Actual Study Completion Date: Dec 1, 2019

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dept. of Oncology, Aalborg University Hospital	Aalborg		Denmark	9000

Sponsors and Collaborators

• Aalborg University Hospital
• Aarhus University Hospital

Investigators

• Principal Investigator: Andreas Carus, MD, PhD, Dept. of oncology, Aalborg University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Andreas Carus, Principal Investigator, Aalborg University Hospital
• ClinicalTrials.gov Identifier: NCT03658460
• Other Study ID Numbers: AaUH ONK 08-2018
• First Posted: Sep 5, 2018
• Last Update Posted: Aug 4, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Andreas Carus, Principal Investigator, Aalborg University Hospital: immunotherapy; immune checkpoint inhibitors; biomarkers; sequencing
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Aug 4, 2021