Study of Lorlatinib In Participants with ALK-Positive NSCLC
Research type
Research Study
Full title
Single-Arm Study of Lorlatinib in Participants with Anaplastic Lymphoma Kinase (ALK)-Positive Non-Small Cell Lung Cancer (NSCLC) Whose Disease Progressed After One Prior Second-Generation ALK Tyrosine Kinase Inhibitor (TKI)
IRAS ID
280691
Contact name
Fiona Blackhall
Contact email
Sponsor organisation
Pfizer Inc.
Eudract number
2019-002504-41
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 2 months, 22 days
Research summary
Lorlatinib has received conditional marketing approval from the European Medicine Agency (EMA) and has been recommended by the NICE (following a technology appraisal) for the treatment of patients with metastatic non-small-cell lung cancer who have a mutation in the ALK gene (ALK-positive NSCLC) and whose disease has progressed after receiving ALK inhibitors. However, due to the small amount of patients who have received lorlatinib, the EMA requested more information about the drug in ALK-positive NSCLC.
Lung cancer is one of the most common cancers in the world and NSCLC makes up about 85% of all lung cancers. Although most patients respond well to ALK inhibitors such as crizotinib and the second-generation drugs alectinib and ceritinib, some patients will not respond to treatment, or later develop resistance or disease progression in the brain and spinal cord. Chemotherapy and/or immunotherapy are the standard of care in these cases, and outcomes with chemotherapy alone have been modest. Lorlatinib offers another treatment option for these patients.
Lorlatinib targets an abnormal form of the ALK gene that causes cancer cells to divide and grow uncontrollably. In a critical Phase 2 study, treatment with lorlatinib showed clinically relevant response rates (42.9% had a reduction in tumour size) and was well-tolerated in participants with ALK-positive NSCLC.
This is a Phase 4 open-label study of lorlatinib in participants with ALK-positive NSCLC who have disease progression after receiving alectinib or ceritinib. 70 participants will be enrolled in this study and will have the following procedures to measure safety and effectiveness; Informed consent, tumour and medical history, physical examination, body weight, ECOG performance status, blood sampling, cardiac monitoring, CT and MRI scans, as well as ongoing monitoring of adverse events and concomitant medications. Participants will be able to receive lorlatinib until disease progression or until they have unacceptable side effects.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
20/NW/0295
Date of REC Opinion
14 Aug 2020
REC opinion
Further Information Favourable Opinion