Non-small-cell Lung CancerLimBioNCT03658460
Immune Checkpoint Inhibitors in Advanced Non-small Cell Lung Cancer and Discovery of New Biomarkers
An observational study of Non-small-cell Lung Cancer and Carcinoma, Non-Small-Cell Lung, run by Aalborg University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small-cell Lung Cancer, Carcinoma, Non-Small-Cell Lung, Lung Neoplasm
- What is being tested?
- DNA sequencing
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 22 Aug 2018to 1 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Candidate for surgical and/or oncological treatment with curative intention
- Other synchronous cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immune Checkpoint Inhibitors in Advanced Non-Small Cell Lung Cancer and Discovery of New Biomarkers
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.
Read more
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.
- Being tested
- DNA sequencing
- Keywords
- immunotherapy, immune checkpoint inhibitors, biomarkers, sequencing
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA sequencingOther
Also called Gene expression analysis
Targeted next generation sequencing and gene expression analysis with focus on immuno-oncology signatures
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Until progression or 1 year after immunotherapy start date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start22 Aug 2018
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small-cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Principal investigator, Andreas Carus, Aalborg University Hospital
- Investigators
- Andreas Carus, MD, PhD, Principal investigator, Dept. of oncology, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03658460
- Sponsor's protocol ID
- AaUH ONK 08-2018
- Acronym
- LimBio
- Status last verified
- Aug 2021
- First submitted
- 29 Aug 2018
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Checkpoint Inhibitors in Advanced Non-Small Cell Lung Cancer and Discovery of New Biomarkers
- ClinicalTrials.gov ID
- NCT03658460
- Acronym / sponsor ID
- LimBio / AaUH ONK 08-2018
- Keywords
- immunotherapy, immune checkpoint inhibitors, biomarkers, sequencing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 22 Aug 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 5 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- Biopsy verified NSCLC
- ≥ 18 years
- WHO/ECOG performance status ≤ 2
- Measurable disease according to RECIST 1.1
- Candidate for immunotherapy treatment
Key exclusion criteria (2 listed)
- Candidate for surgical and/or oncological treatment with curative intention
- Other synchronous cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DNA sequencingAlso: Gene expression analysisTargeted next generation sequencing and gene expression analysis with focus on immuno-oncology signatures | Other | – |
Primary outcome
Predictive, prognostic and resistance signatures
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Carus, MD, PhD principal investigator
Dept. of oncology, Aalborg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small-cell Lung Cancer and Carcinoma, Non-Small-Cell Lung, run by Aalborg University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive, prognostic and resistance signatures (time frame: Until progression or 1 year after immunotherapy start date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2021.