Metastatic Non Small Cell Lung CancerLORLAPULMNCT05167500
Efficacy & Safety Study of Lorlatinib in ALK/ROS1 Metastatic NSCLC Patients With Compassionate Use Treatment
An observational study of Metastatic Non Small Cell Lung Cancer, run by Fundación GECP at 25 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Non Small Cell Lung Cancer
- What is being tested?
- Lorlatinib
- Type of treatment
- Pill or oral medicine
- How many people
- 118 participants
- Where
- 25 sitesSpain
- Study dates
- 9 Dec 2021to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Spain25 sites
Complejo Hospitalario Universitario A Coruña
A Coruña, La Coruña, 15006
Centro Oncológico de Galicia
A Coruña, La Coruña, 15009
Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital del Mar
Barcelona, 08003
Hospital Universitari Quiron Dexeus
Barcelona, 08028
Hospital Clinic de Barcelona
Barcelona, 08036
Hospital Universitario de Burgos
Burgos, 09006
Hospital Puerta del Mar
Cadiz, Cádiz, 11009
Hospital Dr. Josep Trueta
Girona, 17007
Hospital Universitario de Jaén
Jaén, 23007
Hospital Universitario Insular de Gran canaria
Las Palmas de Gran Canaria, Gran Canaria, 35016
Complejo Asistencial Universitario de León
León, 24071
Hospital Gregorio Marañón
Madrid, 28007
Hospital Clínico San Carlos
Madrid, 28040
Hospital 12 De Octubre
Madrid, 28041
Hospital Puerta de Hierro
Madrid, 28222
Hospital Fundación de Alcorcón
Madrid, 28922
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011
Hospital Clínico Santiago
Santiago de Compostela, A Coruña, 15706
Hospital Virgen del Rocio
Seville, 41013
Complejo Hospitalario de Toledo
Toledo, 45004
Hospital Universitari i Politécnic La Fe
Valencia, 46009
Hospital Clínico de Valencia
Valencia, 46010
Hospital General de Valencia
Valencia, 46014
Hospital Clínico Lozano Blesa
Zaragoza, 50009
About this study
Official 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
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.
Read the 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.
- Conditions
- Metastatic Non Small Cell Lung Cancer
- Being tested
- Lorlatinib
- Keywords
- Lung Diseases, Non small cell lung cancer, Metastatic disease, Lorlatinib, ALK alteration, ROS1 alteration
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Diseases, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LorlatinibDrug
Also called Lorviqua
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental : Lorlatinib inn ALK Or ROS1 Metastatic NSCLC patient | 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. Receives: Drug: Lorlatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Progression-free survival defined as time from the first dose of lorlatinib to the first documentation of progression or death from any cause.
Measured: 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
Duration of the response defined from the first documentation of tumor response to the first documentation of tumor progression or death from any cause.
Measured: 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
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
Measured: From date of the first dose of lorlatinib treatment until the date of last follow up or death, assessed up to 60 months
Secondary outcomes (2)
Overall survival of ALK and ROS1 NSCLC patients
Overall survival of ALK and ROS1 NSCLC patients from lorlatinib defined as time from the start of treatment until death or last follow-up
Measured: From date of the first dose of lorlatinib treatment until the date of last follow up or death, assessed up to 60 months
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Occurrence and severity of adverse events, with severity determined by NCI CTCAE v5.0 criteria.
Measured: From date of the first dose of lorlatinib treatment until the date of last follow up or death,assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start9 Dec 2021
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación GECP
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonio Calles, MD, Study chair, Fundación GECP Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05167500
- Sponsor's protocol ID
- GECP 21/04_LORLAPULM
- Acronym
- LORLAPULM
- Status last verified
- Mar 2023
- First submitted
- 9 Nov 2021
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05167500
- Acronym / sponsor ID
- LORLAPULM / GECP 21/04_LORLAPULM
- Conditions
- Metastatic Non Small Cell Lung Cancer
- Keywords
- Lung Diseases, Non small cell lung cancer, Metastatic disease, Lorlatinib, ALK alteration, ROS1 alteration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Fundación GECPUniversity, hospital or other
- Study start
- 9 Dec 2021 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 22 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental : Lorlatinib inn ALK Or ROS1 Metastatic NSCLC patient | – | Drug: LorlatinibPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LorlatinibAlso: LorviquaNo 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. | Drug | Experimental : Lorlatinib inn ALK Or ROS1 Metastatic NSCLC patient |
Primary outcome
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.
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.
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
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- Web page of the sponsor where users can find more information about Fundacion GECP studiesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Calles, MD study chair
Fundación GECP Investigator
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Non Small Cell Lung Cancer, run by Fundación GECP at 25 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2023.