Metastatic Non Small Cell Lung Cancer
Conditions
Keywords
Lung Diseases, Non small cell lung cancer, Metastatic disease, Lorlatinib, ALK alteration, ROS1 alteration
Brief summary
This is an observational, non-interventional, retrospective, multicentre and nationwide study. The information will be obtained retrospectively, in most cases when the treatment has already ended. The primary objective of this study is determine the activity of lorlatinib (percentage of responses, duration of response, progression-free survival and time to treatment failure) of patients included in the compassionate use program in Spain.
Detailed description
This is an observational, non-interventional, retrospective, multicentre and nationwide study. The information will be obtained retrospectively, in most cases when the treatment has already ended. In cases where the patient continues on the treatment, the researcher will not modify the clinical management of the patient by participating in the study. Patients with metastatic non-small cell lung cancer treated with lorlatinib who were included in the compassionate use program in Spain between November 2016 and February 2019 for those with an ALK alteration, and between November 2016 to March 2021 for those with ROS1 alteration. According to the records of the Spanish centres participating in this program, approximately 145 patients have been included. The primary objective of this study is determine the activity of lorlatinib (percentage of responses, duration of response, progression-free survival and time to treatment failure) of patients included in the compassionate use program in Spain.
Interventions
DRUGLorlatinib
No treatment will be administered to the patient as an active treatment of this study. Only retrospective data about the patients treated in the compassion use program of Lorlatinib will be collected. The information below is related to Lorlatinib, target drug for the collection of data. Lorviqua 25 mg film-coated tablets.The recommended dose is 100 mg lorlatinib taken orally once daily. Treatment with lorlatinib is recommended as long as the patient is deriving clinical benefit from therapy without unacceptable toxicity. Dosing interruption or dose reduction may be required based on individual safety and tolerability.Lorlatinib should be permanently discontinued if the patient is unable to tolerate the 50 mg dose taken orally once daily.
Sponsors
Fundación GECP
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with metastatic non-small cell lung cancer treated with lorlatinib who were included in the compassionate use program in Spain between November 2016 and February 2019 for those with an ALK alteration, and between November 2016 to March 2021 for those with ROS1 alteration. * Patients must have been treated with at least one cycle of lorlatinib within the compassionate use program. * Alive patients must have signed, dated the ethics committee approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care.
Exclusion criteria
* Alive patients who refuse to sign and date an ethics committee approved written informed consent form. * Patients who were accepted in the compassionate use program , but did not receive treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | From date of the first dose of lorlatinib treatment until the date of last follow up or death, assessed up to 60 months | Progression-free survival defined as time from the first dose of lorlatinib to the first documentation of progression or death from any cause. |
| Duration of the response | From date of the first dose of lorlatinib treatment until the date of last follow up or death, assessed up to 60 months | Duration of the response defined from the first documentation of tumor response to the first documentation of tumor progression or death from any cause. |
| Time to treatment failure | From date of the first dose of lorlatinib treatment until the date of last follow up or death, assessed up to 60 months | Time to treatment failure defined as time from the first dose of lorlatinib to the moment of discontinuation of treatment for any cause, including tumor progression, toxicity or death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival of ALK and ROS1 NSCLC patients | From date of the first dose of lorlatinib treatment until the date of last follow up or death, assessed up to 60 months | Overall survival of ALK and ROS1 NSCLC patients from lorlatinib defined as time from the start of treatment until death or last follow-up |
| Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) | From date of the first dose of lorlatinib treatment until the date of last follow up or death,assessed up to 60 months | Occurrence and severity of adverse events, with severity determined by NCI CTCAE v5.0 criteria. |
Countries
Spain
Outcome results
None listed