Clinical trial NCT02894853: Lung Cancer Early Molecular Assessment Trial
Official title: Lung Cancer Early Molecular Assessment Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
Collaborators: name: AstraZeneca
name: Roche Pharma AG
name: Merck Sharp & Dohme LLC
First posted: 2016-09-09
Enrollment: 1297
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The percentage of patients with EGFR mutation or ALK translocation using the combined tumour tissue and liquid biopsy analysis
timeFrame: 3 years
Secondary outcomes:
measure: Include the test performance of both techniques in different stage of disease
timeFrame: 3 years
measure: The percentage of patients with a predefined actionable genetic alteration
timeFrame: 3 years
measure: The costs
timeFrame: 3 years
measure: The influence of the liquid biopsies on the diagnostic yield of tissue molecular and pathological analysis.
timeFrame: 3 years
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Antoni van Leeuwenhoek
state: North-Holland
Study officials:
affiliation: Antoni van Leeuwenhoek
name: Michel van den Heuvel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.