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Lung Cancer Early Molecular Assessment Trial

Lung Cancer Early Molecular Assessment Trial

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02894853
Acronym
LEMA
Enrollment
1297
Registered
2016-09-09
Start date
2016-06-30
Completion date
2019-12-31
Last updated
2017-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Brief 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. 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.

Interventions

GENETICLiquid (blood) biopsies and tumor biopsy (optional)

Liquid (blood) biopsies: 40 ml (maximal 10 times per patient) Tumor biopsy (optional)

Sponsors

AstraZeneca
CollaboratorINDUSTRY
Roche Pharma AG
CollaboratorINDUSTRY
Merck Sharp & Dohme LLC
CollaboratorINDUSTRY
The Netherlands Cancer Institute
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* Not motivated to receive any treatment at any point in time. Patients who consider undergoing treatment in the future are eligible.

Design outcomes

Primary

MeasureTime frameDescription
The percentage of patients with EGFR mutation or ALK translocation using the combined tumour tissue and liquid biopsy analysis3 yearsPatients with EGFR mutation or ALK translocation using the combined tumour tissue and liquid biopsy analysis

Secondary

MeasureTime frameDescription
Include the test performance of both techniques in different stage of disease3 yearsTest performance of both techniques in different stage of disease
The percentage of patients with a predefined actionable genetic alteration3 yearsPatients with a predefined actionable genetic alteration
The costs3 yearsThe costs
The influence of the liquid biopsies on the diagnostic yield of tissue molecular and pathological analysis.3 yearsLiquid biopsies on the diagnostic yield of tissue molecular

Countries

Netherlands

Contacts

Primary ContactMichel van den Heuvel, MD
m.vd.heuvel@nki.nl0031-20-512
Backup ContactRobert Schouten, MSc
r.schouten@nki.nl0031-20-512

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 5, 2026