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Brief Title: Activity of Lorlatinib Based on ALK Resistance Mutations Detected on Blood in ALK Positive NSCLC Patients
Official Title: Activity of Lorlatinib Based on ALK Resistance Mutations on Blood in ALK Positive NSCLC Patients Previously Treated With 2nd Generation ALK Inhibitor
Study ID: NCT04127110
Brief Summary: This study includes patients diagnosed with a metastatic non small cell lung cancer (NSCLC) with anaplastic lymphoma kinase (ALK) translocation. The standard treatment for patients with metastatic non small cell lung cancer with ALK translocation is represented by personalized treatment with drugs called ALK inhibitors. During the treatment with an ALK inhibitor, the tumour can start to grow again, because the tumour adapts to the drug and develops escape mechanisms, becoming resistant. At the tumour cells level, the mechanisms underlying resistance can include the development of other alterations, mainly mutations, including in the ALK gene. The alterations that developed depend on the drug the tumour has been exposed to. The alterations can be identified by analysing tumour tissue obtained through a biopsy, however, repeating a tumour biopsy is difficult and risky and might not be able to provide sufficient tissue for the test. Therefore in the last years, new tests have been developed to identify the mutations in the blood. Lorlatinib is a drug that inhibits ALK and has already been identified to be able to control the tumour growth when ALK mutations are identified and is already approved as standard treatment after progression to a previous treatment with ALK inhibitors. The purpose of this study is to identify which patient populations may benefit most from treatment with lorlatinib, based on the alterations found in their genes.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Institut Jules Bordet-Hopital Universitaire ULB, Brussels, , Belgium
Cliniques Universitaires Saint-Luc, Brussels, , Belgium
Universitair Ziekenhuis Antwerpen, Edegem, , Belgium
CHU-UCL Namur - CHU Mont Godinne - UCL Namur, Yvoir, , Belgium
Centre Hospitalier Avignon, Avignon, , France
Assistance Publique Hopitaux Paris - Hopital Avicenne, Bobigny, , France
CHU de Brest, Brest, , France
Centre Hopitalier Intercommunal De Creteil, Créteil, , France
Gustave Roussy, Villejuif, , France
King Hussein Cancer Center, Amman, , Jordan
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis, Amsterdam, , Netherlands
Academisch Ziekenhuis Maastricht, Maastricht, , Netherlands
Erasmus MC, Rotterdam, , Netherlands
Oslo University Hospital - Radiumhospitalet, Oslo, , Norway
Institut Catala d'Oncologia - ICO L'Hospitalet - Hospital Duran i Reynals, Hospitalet De Llobregat, Barcelona, Spain
Hospital Clinic Universitari de Barcelona, Barcelona, , Spain
Hospital De La Santa Creu I Sant Pau, Barcelona, , Spain
Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol, Barcelona, , Spain
Hospital General Universitario Gregorio Maranon, Madrid, , Spain
Clinica Universidad de Navarra - Clinica Universitaria De Navarra, Madrid, , Spain
Hospital Universitario 12 De Octubre, Madrid, , Spain
Hospital Universitario Ramon y Cajal, Madrid, , Spain
Hospital Universitari Son Espases, Palma De Mallorca, , Spain
Clinica Universidad de Navarra - Clinica Universitaria De Navarra, Pamplona, , Spain
University Hospital Virgen del Rocio, Sevilla, , Spain
The Christie NHS Foundation Trust, Manchester, , United Kingdom
Name: Anne-Marie Dingemans, MD
Affiliation: Erasmus MC, Rotterdam, Netherlands
Role: PRINCIPAL_INVESTIGATOR
Name: Laura Mezquita, MD
Affiliation: Hospital Clinic Universitari de Barcelona, Spain
Role: PRINCIPAL_INVESTIGATOR