Activity of Lorlatinib Based on ALK Resistance Mutations Detected on Blood in ALK Positive NSCLC Patients
- Registration Number
- 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
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 68
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Lorlatinib Lorlatinib Lorlatinib is administered orally at the daily dose of 100 mg (four tablets of 25 mg). Lorlatinib will be taken continuously on a daily basis until disease progression, unacceptable toxicity, occurrence of any withdrawal criterion, whichever comes first.
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS) 12 months after enrolment of last patient Progression Free Survival Rate at 12 months (PFSR-12) is defined as the proportion of patients at 12 months who are alive and non-progressing.
- Secondary Outcome Measures
Name Time Method Overall Response Rate (ORR) 12 months after enrolment of last patient Overall Response Rate (ORR) is an overall rate including patients with documented complete response (CR) or partial response (PR)
CNS Overall Response Rate (CNS-ORR) 12 months after enrolment of last patient CNS Overall Response Rate (CNS ORR) is an overall rate including patients with documented complete response (CNS-CR) or partial response (CNS-PR)
Overall Survival (OS) 12 months after enrolment of last patient OS is defined as the time interval between the date of enrolment and the date of death from any cause. If no event has been observed, then the patient is censored at the last date known to be alive.
Duration of Response (DOR) 12 months after enrolment of last patient Duration of Response will only be reported for patients who achieved either CR or PR. The duration of response is measured from the time measurement criteria are met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. If progression has not been observed, the patient will be censored at the date of the last follow up examination. In the event of death without progression competing risk method will be used.
Safety profile according to NCI CTCAE v.5 30 days after last dose Safety profile according to NCI CTCAE v.5
Trial Locations
- Locations (25)
Cliniques Universitaires Saint-Luc
🇧🇪Brussels, Belgium
Hospital Universitari Son Espases
🇪🇸Palma De Mallorca, Spain
The Christie NHS Foundation Trust
🇬🇧Manchester, United Kingdom
Gustave Roussy
🇫🇷Villejuif, France
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
Centre Hopitalier Intercommunal De Creteil
🇫🇷Créteil, France
Clinica Universidad de Navarra - Clinica Universitaria De Navarra
🇪🇸Pamplona, Spain
Hospital Clinic Universitari de Barcelona
🇪🇸Barcelona, Spain
University Hospital Virgen del Rocio
🇪🇸Sevilla, Spain
Hospital Universitario Ramon y Cajal
🇪🇸Madrid, Spain
Hospital Universitario 12 De Octubre
🇪🇸Madrid, Spain
Hospital De La Santa Creu I Sant Pau
🇪🇸Barcelona, Spain
Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol
🇪🇸Barcelona, Spain
CHU de Brest
🇫🇷Brest, France
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis
🇳🇱Amsterdam, Netherlands
CHU-UCL Namur - CHU Mont Godinne - UCL Namur
🇧🇪Yvoir, Belgium
Institut Jules Bordet-Hopital Universitaire ULB
🇧🇪Brussels, Belgium
Centre Hospitalier Avignon
🇫🇷Avignon, France
Academisch Ziekenhuis Maastricht
🇳🇱Maastricht, Netherlands
Erasmus MC
🇳🇱Rotterdam, Netherlands
King Hussein Cancer Center
🇯🇴Amman, Jordan
Oslo University Hospital - Radiumhospitalet
🇳🇴Oslo, Norway
Hospital General Universitario Gregorio Maranon
🇪🇸Madrid, Spain
Institut Catala d'Oncologia - ICO L'Hospitalet - Hospital Duran i Reynals
🇪🇸Hospitalet De Llobregat, Barcelona, Spain
Assistance Publique Hopitaux Paris - Hopital Avicenne
🇫🇷Bobigny, France