Metastatic Nonsmall Cell Lung CancerNCT03512847
Predictive Gene Profiles and Dynamic Measurement of Treatment Response in Metastatic Non-small Cell Lung Cancer
An observational study of Metastatic Nonsmall Cell Lung Cancer, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
The study aims include: Exploring potential predictive molecular profiles to immunotherapy/chemotherapy Investigating the role of circulating tumor DNA as a dynamic biomarker during immunotherapy/chemotherapy Identifying possible resistance mechanisms to immunotherapy/chemotherapy Materials and methods: Approximately… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Nonsmall Cell Lung Cancer
- How many people
- 150 participants
- Where
- 1 siteDenmark
- Study dates
- 29 May 2018to 6 Nov 2022
- 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: Metastatic non-small cell lung cancer.
Who may be able to join
- Age > 18 years
- Able to understand and read Danish
- WHO Performance status 0-2
- Acceptable organ function (liver/kidney/heart) for treatment
- The disease has to be:
- evaluable or measurable according to RECIST/iRECIST accessible for biopsy metastatic or not suitable for curative intended treatment
Who cannot join
- Other active cancers
- Contraindications for systemic therapy
- ALK-positive, ROS-1 or EGFR mutations
Trial locations and contacts
1 site in 1 country.
About this study
The study aims include:
- Exploring potential predictive molecular profiles to immunotherapy/chemotherapy
- Investigating the role of circulating tumor DNA as a dynamic biomarker during immunotherapy/chemotherapy
- Identifying possible resistance mechanisms to immunotherapy/chemotherapy
Read more
Materials and methods:
Approximately 150 patients diagnosed with metastatic NSCLC assigned for immunotherapy or chemotherapy will be candidates for inclusion during a 1-2 years period.
A comprehensive molecular profiling will be made from the diagnostic biopsy. Before every treatment-cycle a blood sample will be taken to quantify ctDNA. At time of progressive disease during/after first line treatment, patients will be asked to participate in a new biopsy and a comprehensive molecular profiling will be performed.
The tissue and blood samples collected will be stored in a biobank. Clinical data will be collected to perform a comprehensive database.
Analysis:
Potentially predictive molecular profiles for immunotherapy/chemotherapy will be found by comparison of treatment outcome for patients with specific molecular characteristics.
Through quantification of ctDNA during treatment and upon progression, the role of ctDNA as a dynamic biomarker will be further strengthened.
Differences in molecular profiles pre- and post-treatment may reveal resistance mechanisms to treatment. Molecular profiling on progression can be valuable in second-line treatment guidance.
- Conditions
- Metastatic Nonsmall Cell Lung Cancer
- Keywords
- liquid biopsy, genomic profiling, ctDNA
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive gene profiles
Concordance between specific gene profiles and treatment outcomes
Measured: until progression or death, an average of 3 years
Resistance mechanisms toward chemotherapy and immunotherapy
Differences in molecular profiles pre- and post-treatment
Measured: until progression or death, an average of 3 years
ctDNA as a dynamic biomarker
Quantification of ctDNA during treatment linked to treatment outcome
Measured: until progression or death, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2018
- Study start29 May 2018
- Primary completion6 Nov 2022
- Study completion6 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metastatic Nonsmall Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Zealand 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frank S Malene, MD, Principal investigator, Region Zeland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03512847
- Sponsor's protocol ID
- REG-006-2018
- Status last verified
- Feb 2023
- First submitted
- 26 Mar 2018
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Frank MS, Andersen CSA, Ahlborn LB, Pallisgaard N, Bodtger U, Gehl J. Circulating Tumor DNA Monitoring Reveals Molecular Progression before Radiologic Progression in a Real-life Cohort of Patients with Advanced Non-small Cell Lung Cancer. Cancer Res Commun. 2022 Oct 13;2(10):1174-1187. doi: 10.1158/2767-9764.CRC-22-0258. eCollection 2022 Oct.
PubMed 36969747Frank MS, Bodtger U, Hoegholm A, Stamp IM, Gehl J. Re-biopsy after first line treatment in advanced NSCLC can reveal changes in PD-L1 expression. Lung Cancer. 2020 Nov;149:23-32. doi: 10.1016/j.lungcan.2020.08.020. Epub 2020 Sep 12.
PubMed 32949828
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Gene Profiles and Dynamic Measurement of Treatment Response in Metastatic Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03512847
- Acronym / sponsor ID
- REG-006-2018
- Conditions
- Metastatic Nonsmall Cell Lung Cancer
- Keywords
- liquid biopsy, genomic profiling, ctDNA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- 29 May 2018 (actual)
- Primary completion
- 6 Nov 2022 (actual)
- Study completion
- 6 Nov 2022 (actual)
- First posted
- 1 May 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.
The study aims include:
- Exploring potential predictive molecular profiles to immunotherapy/chemotherapy
- Investigating the role of circulating tumor DNA as a dynamic biomarker during immunotherapy/chemotherapy
- Identifying possible resistance mechanisms to immunotherapy/chemotherapy
Materials and methods:
Approximately 150 patients diagnosed with metastatic NSCLC assigned for immunotherapy or chemotherapy will be candidates for inclusion during a 1-2 years period.
A comprehensive molecular profiling will be made from the diagnostic biopsy. Before every treatment-cycle a blood sample will be taken to quantify ctDNA. At time of progressive disease during/after first line treatment, patients will be asked to participate in a new biopsy and a comprehensive molecular profiling will be performed.
The tissue and blood samples collected will be stored in a biobank. Clinical data will be collected to perform a comprehensive database.
Analysis:
Potentially predictive molecular profiles for immunotherapy/chemotherapy will be found by comparison of treatment outcome for patients with specific molecular characteristics.
Through quantification of ctDNA during treatment and upon progression, the role of ctDNA as a dynamic biomarker will be further strengthened.
Differences in molecular profiles pre- and post-treatment may reveal resistance mechanisms to treatment. Molecular profiling on progression can be valuable in second-line treatment guidance.
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
- Metastatic non-small cell lung cancer.
Key inclusion criteria (6 listed)
- Age > 18 years
- Able to understand and read Danish
- WHO Performance status 0-2
- Acceptable organ function (liver/kidney/heart) for treatment
- The disease has to be:
Key exclusion criteria (3 listed)
- Other active cancers
- Contraindications for systemic therapy
- ALK-positive, ROS-1 or EGFR mutations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Predictive gene profiles
Time frame: until progression or death, an average of 3 years
Concordance between specific gene profiles and treatment outcomes
Resistance mechanisms toward chemotherapy and immunotherapy
Time frame: until progression or death, an average of 3 years
Differences in molecular profiles pre- and post-treatment
ctDNA as a dynamic biomarker
Time frame: until progression or death, an average of 3 years
Quantification of ctDNA during treatment linked to treatment outcome
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 6 Feb 2023.
- Derived from this study: PubMed 36969747Frank MS, Andersen CSA, Ahlborn LB, Pallisgaard N, Bodtger U, Gehl J. Circulating Tumor DNA Monitoring Reveals Molecular Progression before Radiologic Progression in a Real-life Cohort of Patients with Advanced Non-small Cell Lung Cancer. Cancer Res Commun. 2022 Oct 13;2(10):1174-1187. doi: 10.1158/2767-9764.CRC-22-0258. eCollection 2022 Oct.
- Derived from this study: PubMed 32949828Frank MS, Bodtger U, Hoegholm A, Stamp IM, Gehl J. Re-biopsy after first line treatment in advanced NSCLC can reveal changes in PD-L1 expression. Lung Cancer. 2020 Nov;149:23-32. doi: 10.1016/j.lungcan.2020.08.020. Epub 2020 Sep 12.
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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.
Frank S Malene, MD principal investigator
Region Zeland
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 Metastatic Nonsmall Cell Lung Cancer, run by Zealand 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 6 inclusion and 3 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 6 Feb 2023. 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 gene profiles (time frame: until progression or death, an average of 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03512847, which also lists 2 linked publications.
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 6 Feb 2023.