Lung Cancer Early Molecular Assessment Trial

• Conditions: Carcinoma, Non-Small-Cell Lung

• Registration Number: NCT02894853
• Lead Sponsor: The Netherlands Cancer Institute

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.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-09-05
• Study First Submitted QC: 2016-09-08
• Study First Posted: 2016-09-09
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-13
• Last Update Posted: 2017-09-14
• Primary Completion: 2019-06
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1297

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The percentage of patients with EGFR mutation or ALK translocation using the combined tumour tissue and liquid biopsy analysis	3 years	Patients with EGFR mutation or ALK translocation using the combined tumour tissue and liquid biopsy analysis

Secondary Outcome Measures

Name	Time	Method
The influence of the liquid biopsies on the diagnostic yield of tissue molecular and pathological analysis.	3 years	Liquid biopsies on the diagnostic yield of tissue molecular
Include the test performance of both techniques in different stage of disease	3 years	Test performance of both techniques in different stage of disease
The percentage of patients with a predefined actionable genetic alteration	3 years	Patients with a predefined actionable genetic alteration
The costs	3 years	The costs

Trial Locations

Locations (1)

Antoni van Leeuwenhoek; 🇳🇱 Amsterdam, North-Holland, Netherlands