Overview

This trial is active, not recruiting.

Condition carcinoma, non-small-cell lung
Treatment liquid (blood) biopsies and tumor biopsy (optional)
Sponsor The Netherlands Cancer Institute
Collaborator AstraZeneca
Start date June 2016
End date June 2019
Trial size 1297 participants
Trial identifier NCT02894853, M15LEM, NL54778.031.15

Summary

We 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective prospective

Primary Outcomes

Measure
The percentage of patients with EGFR mutation or ALK translocation using the combined tumour tissue and liquid biopsy analysis
time frame: 3 years

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Lung Cancer Early Molecular Assessment Trial
Principal investigator Michel van den Heuvel, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by The Netherlands Cancer Institute.