Lung CancerMonAlecNCT04708639
Monitoring Alectinib Treatment by Detection of ALK Translocations in Serial Blood Samples From Non-Small Cell Lung Cancer Patients
An observational study of Lung Cancer and ALK Gene Mutation, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
Circulating tumor DNA can be used to monitor the treatment effect and identify developing resistance mutations during ALK directed TKI treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, ALK Gene Mutation, Resistance, Disease
- What is being tested?
- Alectinib
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 19 Jun 2019to 30 Jun 2025
- 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: All newly diagnosed ALK translocated lung cancer adenocarcinomas.
Who may be able to join
- Patients with ALK translocated metastatic NSCLC, treated with alectinib as 1st line therapy in routine clinical practice
- Written (personally dated and signed) informed consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Circulating tumor DNA can be used to monitor the treatment effect and identify developing resistance mutations during ALK directed TKI treatment.
Read the detailed description
The purpose and objectives of the non-interventional study with primary data collection is
- To determine if monitoring the amount of translocated DNA in the blood reflects alectinib treatment effect.
- To assess the presence and type of resistance mutations using ctDNA at the time patients experience clinical progression on alectinib.
- To investigate if the resistance mutations identified at clinical progression could have been identified in blood samples taken before clinically evident progression.
- Conditions
- Lung Cancer, ALK Gene Mutation, Resistance, Disease, Mutation
- Being tested
- Alectinib
- Medical subject headings
- Lung Neoplasms, Disease Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlectinibDrug
Use of ctDNA to establish response and resistance to alectinib.
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS on alectinib
time from initiation of treatment to progression
Measured: 46 month
mechanism of resistance
ctDNA to establish resistance mechanisms to alectinib treatment
Measured: 15.2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start19 Jun 2019
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Aarhus 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Responsible party
- Principal investigator, Peter Meldgaard, Aarhus University Hospital
- Investigators
- Peter Meldgaard, MD, PhD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04708639
- Sponsor's protocol ID
- ML40920
- Acronym
- MonAlec
- Status last verified
- Jan 2021
- First submitted
- 12 Jan 2021
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All data will be published
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Alectinib Treatment by Detection of ALK Translocations in Serial Blood Samples From Non-Small Cell Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT04708639
- Acronym / sponsor ID
- MonAlec / ML40920
- Conditions
- Lung Cancer, ALK Gene Mutation, Resistance, Disease, Mutation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- 19 Jun 2019 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 14 Jan 2021 (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.
Circulating tumor DNA can be used to monitor the treatment effect and identify developing resistance mutations during ALK directed TKI treatment.
Detailed description
The purpose and objectives of the non-interventional study with primary data collection is
- To determine if monitoring the amount of translocated DNA in the blood reflects alectinib treatment effect.
- To assess the presence and type of resistance mutations using ctDNA at the time patients experience clinical progression on alectinib.
- To investigate if the resistance mutations identified at clinical progression could have been identified in blood samples taken before clinically evident progression.
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
- All newly diagnosed ALK translocated lung cancer adenocarcinomas.
Key inclusion criteria (2 listed)
- Patients with ALK translocated metastatic NSCLC, treated with alectinib as 1st line therapy in routine clinical practice
- Written (personally dated and signed) informed consent
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| AlectinibUse of ctDNA to establish response and resistance to alectinib. | Drug | – |
Primary outcome
PFS on alectinib
Time frame: 46 month
time from initiation of treatment to progression
mechanism of resistance
Time frame: 15.2 month
ctDNA to establish resistance mechanisms to alectinib treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Individual participant dataSharing planned: Undecided. All data will be published
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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.
Peter Meldgaard, MD, PhD principal investigator
Aarhus 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 Lung Cancer and ALK Gene Mutation, run by Aarhus 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 2 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 2 Feb 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?
Results are not available in the source record.
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?
PFS on alectinib (time frame: 46 month). The study lists 2 primary outcomes in all. 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 2 Feb 2021.