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Spots Global Cancer Trial Database for Activity of Lorlatinib Based on ALK Resistance Mutations Detected on Blood in ALK Positive NSCLC Patients

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Trial Identification

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

Interventions

Lorlatinib

Study Description

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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