Lung Cancer Early Molecular Assessment Trial

Carcinoma, Non-Small-Cell Lung Clinical Trial

— LEMA  

Official title:

Lung Cancer Early Molecular Assessment Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02894853
• Other study ID #: M15LEM
• Secondary ID: NL54778.031.15
• Status: Recruiting
• Phase: N/A
• First received: September 5, 2016
• Last updated: September 13, 2017
• Start date: June 2016
• Est. completion date: December 2019

Study information

• Verified date: September 2017
• Source: The Netherlands Cancer Institute
• Contact: Michel van den Heuvel, MD
• Phone: 0031-20-512
• Email: m.vd.heuvel[@]nki.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1297
• Est. completion date: December 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

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

Locations

Country	Name	City	State
Netherlands	Antoni van Leeuwenhoek	Amsterdam	North-Holland

Sponsors (4)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute	AstraZeneca, Merck Sharp & Dohme Corp., Roche Pharma AG

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of patients with EGFR mutation or ALK translocation using the combined tumour tissue and liquid biopsy analysis	Patients with EGFR mutation or ALK translocation using the combined tumour tissue and liquid biopsy analysis	3 years
Secondary	Include the test performance of both techniques in different stage of disease	Test performance of both techniques in different stage of disease	3 years
Secondary	The percentage of patients with a predefined actionable genetic alteration	Patients with a predefined actionable genetic alteration	3 years
Secondary	The costs	The costs	3 years
Secondary	The influence of the liquid biopsies on the diagnostic yield of tissue molecular and pathological analysis.	Liquid biopsies on the diagnostic yield of tissue molecular	3 years