Lung Cancer Early Molecular Assessment Trial (LEMA)

Netherlands Cancer Institute (NKI)

Status: Unknown

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Genetic: Liquid (blood) biopsies and tumor biopsy (optional)

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02894853

NL54778.031.15 (Other Identifier)

M15LEM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,297 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.