Carcinoma, Non-Small-Cell LungLEMANCT02894853
Lung Cancer Early Molecular Assessment Trial
An observational study of Carcinoma, Non-Small-Cell Lung, run by The Netherlands Cancer Institute at 1 site in Netherlands.
Trial summary
The investigators hypothesize that an early molecular profiling, that includes both tissue and blood-bases analysis, for all NSCLC patients, including stage I-III, will increase diagnostic efficiency. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Liquid (blood) biopsies and tumor biopsy (optional)
- How many people
- 1,297 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2016to 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: All patients presenting with NSCLC will be profiled upfront, irrespective of disease stage and pathology using both tissue and blood-based genetic testing
Who may be able to join
- Suspicion of lung carcinoma or established NSCLC but awaiting start of definitive treatment
- Written informed consent to undergo diagnostic procedure and molecular analysis of the disease.
Who cannot join
- Not motivated to receive any treatment at any point in time. Patients who consider undergoing treatment in the future are eligible.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Antoni van Leeuwenhoek
Amsterdam, North Holland, 1066CX
Michael van den Heuvel, MD, +31-20-512 ext. 9111, m.vd.heuvel@nki.nl
Robert Schouten, MD, +31-20-512 ext. 9111, r.schouten@nki.nl
About this study
The investigators hypothesize that an early molecular profiling, that includes both tissue and blood-bases analysis, for all NSCLC patients, including stage I-III, will increase diagnostic efficiency. When molecular profiles are available at an earlier stage of disease, more patients will benefit from personalized therapy once needed. This will result in both a better quality of life and outcome.
Read the detailed description
In this prospective multicentre trial tumours of all patients presenting with NSCLC will be profiled upfront, irrespective of disease stage and pathology using both tissue and blood-based genetic testing. A minimal molecular profiling is depicted but other targets will be included in due time. The study is divided in two parts. In the first part participating centres will have a run-in period of half a year in which molecular profiling is performed as is currently standard of care. This period will be used to measure the impact of increased awareness on the diagnostic process. During the second part of the study a comprehensive upfront profiling according to local standards will take place for all NSCLC patients. Liquid (blood) biopsies will be included in order to increase the diagnostic yield for those patients where tissue biopsies are not adequate. Patients will be treated according to standard of care, or included in clinical studies where appropriate. Re-biopsies (both tissue and liquid) will be advocated at the time of establishing disease progression/disseminated disease, and personalized therapy will be initiated according to the existing data from the molecular profiling.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Liquid (blood) biopsies and tumor biopsy (optional)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liquid (blood) biopsies and tumor biopsy (optional)Genetic
Liquid (blood) biopsies: 40 ml (maximal 10 times per patient) Tumor biopsy (optional)
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients with EGFR mutation or ALK translocation using the combined tumour tissue and liquid biopsy analysis
Patients with EGFR mutation or ALK translocation using the combined tumour tissue and liquid biopsy analysis
Measured: 3 years
Secondary outcomes (4)
Include the test performance of both techniques in different stage of disease
Test performance of both techniques in different stage of disease
Measured: 3 years
The percentage of patients with a predefined actionable genetic alteration
Patients with a predefined actionable genetic alteration
Measured: 3 years
The costs
The costs
Measured: 3 years
The influence of the liquid biopsies on the diagnostic yield of tissue molecular and pathological analysis.
Liquid biopsies on the diagnostic yield of tissue molecular
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,297 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, Roche Pharma AG, Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Michel van den Heuvel, MD, Principal investigator, Antoni van Leeuwenhoek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02894853
- Sponsor's protocol ID
- M15LEM
- Other IDs
- NL54778.031.15
- Acronym
- LEMA
- Status last verified
- Sep 2017
- First submitted
- 5 Sep 2016
- Last updated
- 14 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Schuurbiers M, Huang Z, Saelee S, Javey M, de Visser L, van den Broek D, Heuvel MVD, Lovejoy AF, Monkhorst K, Klass D. Biological and technical factors in the assessment of blood-based tumor mutational burden (bTMB) in patients with NSCLC. J Immunother Cancer. 2022 Feb;10(2):e004064. doi: 10.1136/jitc-2021-004064.
PubMed 35217576
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Cancer Early Molecular Assessment Trial
- ClinicalTrials.gov ID
- NCT02894853
- Acronym / sponsor ID
- LEMA / M15LEM
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,297 participants (estimated)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Collaborators
- AstraZeneca, Roche Pharma AG, Merck Sharp & Dohme LLC
- Study start
- Jun 2016
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 9 Sep 2016 (estimated)
- 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 investigators hypothesize that an early molecular profiling, that includes both tissue and blood-bases analysis, for all NSCLC patients, including stage I-III, will increase diagnostic efficiency. When molecular profiles are available at an earlier stage of disease, more patients will benefit from personalized therapy once needed. This will result in both a better quality of life and outcome.
Detailed description
In this prospective multicentre trial tumours of all patients presenting with NSCLC will be profiled upfront, irrespective of disease stage and pathology using both tissue and blood-based genetic testing. A minimal molecular profiling is depicted but other targets will be included in due time. The study is divided in two parts. In the first part participating centres will have a run-in period of half a year in which molecular profiling is performed as is currently standard of care. This period will be used to measure the impact of increased awareness on the diagnostic process. During the second part of the study a comprehensive upfront profiling according to local standards will take place for all NSCLC patients. Liquid (blood) biopsies will be included in order to increase the diagnostic yield for those patients where tissue biopsies are not adequate. Patients will be treated according to standard of care, or included in clinical studies where appropriate. Re-biopsies (both tissue and liquid) will be advocated at the time of establishing disease progression/disseminated disease, and personalized therapy will be initiated according to the existing data from the molecular profiling.
Study design
- Observational model
- Other
- 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 patients presenting with NSCLC will be profiled upfront, irrespective of disease stage and pathology using both tissue and blood-based genetic testing
Key inclusion criteria (2 listed)
- Suspicion of lung carcinoma or established NSCLC but awaiting start of definitive treatment
- Written informed consent to undergo diagnostic procedure and molecular analysis of the disease.
Key exclusion criteria (1 listed)
- Not motivated to receive any treatment at any point in time. Patients who consider undergoing treatment in the future are eligible.
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 |
|---|---|---|
| Liquid (blood) biopsies and tumor biopsy (optional)Liquid (blood) biopsies: 40 ml (maximal 10 times per patient) Tumor biopsy (optional) | Genetic | – |
Primary outcome
The percentage of patients with EGFR mutation or ALK translocation using the combined tumour tissue and liquid biopsy analysis
Time frame: 3 years
Patients with EGFR mutation or ALK translocation using the combined tumour tissue and liquid biopsy analysis
4 secondary outcomes
Include the test performance of both techniques in different stage of disease
Time frame: 3 years
The percentage of patients with a predefined actionable genetic alteration
Time frame: 3 years
The costs
Time frame: 3 years
The influence of the liquid biopsies on the diagnostic yield of tissue molecular and pathological analysis.
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2017.
- Derived from this study: PubMed 35217576Schuurbiers M, Huang Z, Saelee S, Javey M, de Visser L, van den Broek D, Heuvel MVD, Lovejoy AF, Monkhorst K, Klass D. Biological and technical factors in the assessment of blood-based tumor mutational burden (bTMB) in patients with NSCLC. J Immunother Cancer. 2022 Feb;10(2):e004064. doi: 10.1136/jitc-2021-004064.
- 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.
Michel van den Heuvel, MD principal investigator
Antoni van Leeuwenhoek
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 Carcinoma, Non-Small-Cell Lung, run by The Netherlands Cancer Institute at 1 site in Netherlands.
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 1 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 14 Sep 2017. 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 Netherlands. 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?
Contact Michel van den Heuvel, MD (0031-20-512 ext. 9111, m.vd.heuvel@nki.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of patients with EGFR mutation or ALK translocation using the combined tumour tissue and liquid biopsy analysis (time frame: 3 years). 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 NCT02894853, which also lists 1 linked publication.
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 14 Sep 2017.