Lung Cancer Early Molecular Assessment Trial

NCT ID: NCT02894853

Last Updated: 2017-09-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1297 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2019-12-31

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

Liquid (blood) biopsies and tumor biopsy (optional)

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

Intervention Type: GENETIC

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

Roche Pharma AG

INDUSTRY

Sponsor Role: collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

The Netherlands Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michel van den Heuvel, MD

Role: PRINCIPAL_INVESTIGATOR

Antoni van Leeuwenhoek

Locations

Antoni van Leeuwenhoek

Amsterdam, North Holland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Michel van den Heuvel, MD

Role: CONTACT

m.vd.heuvel@nki.nl

0031-20-512 ext. 9111

Robert Schouten, MSc

Role: CONTACT

r.schouten@nki.nl

0031-20-512 ext. 9111

Facility Contacts

Michael van den Heuvel, MD

Role: primary

m.vd.heuvel@nki.nl

+31-20-512 ext. 9111

Robert Schouten, MD

Role: backup

r.schouten@nki.nl

+31-20-512 ext. 9111

References

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.

Reference Type: DERIVED

PMID: 35217576 (View on PubMed)

Other Identifiers

NL54778.031.15

Identifier Type: OTHER

Identifier Source: secondary_id

M15LEM

Identifier Type: -

Identifier Source: org_study_id