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Completed

NCT Number: NCT05167500

Efficacy & Safety Study of Lorlatinib in ALK/ROS1 Metastatic NSCLC Patients With Compassionate Use Treatment

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.

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Key information

Conditions

Metastatic Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Clínico Santiago, Santiago de Compostela, A Coruña, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lorlatinib

Drug

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.

Other names: Lorviqua

Primary outcomes

  1. Progression-free survival

    Time frame: 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.

  2. Duration of the response

    Time frame: 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.

  3. Time to treatment failure

    Time frame: 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 outcomes

  1. Overall survival of ALK and ROS1 NSCLC patients

    Time frame: 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

  2. Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fundación GECP

Other

Registry information

Official study title

Retrospective, Observational Study On The Efficacy And Safety Of Lorlatinib In ALK or ROS1 Metastatic Non-Small Cell Lung Cancer Patients Treated Within The Compassionate Use Program In Spain

Acronym: LORLAPULM

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 22, 2021
Registry last updated
Mar 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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