Non-small Cell Lung Cancer MetastaticLORLATUNCT03727477
Efficacy of Treatment Sequences in Patients With Non-small Cell Lung Cancer Receiving Lorlatinib
An observational study of Non-small Cell Lung Cancer Metastatic and ALK Gene Rearrangement Positive, run by Intergroupe Francophone de Cancerologie Thoracique at 30 sites in France.
Trial summary
The study will evaluate progression-free survival, overall survival, best response and duration of treatment in patients with advanced ALK- and ROS1-positive non-small cell lung cancer who received lorlatinib as part of the French expanded access program. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer Metastatic, ALK Gene Rearrangement Positive, ROS-1 Gene Rearrangement Positive
- How many people
- 291 participants
- Where
- 30 sitesFrance
- Study dates
- 1 Feb 2019to 12 Oct 2020
- 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 histologically or cytologically confirmed locally advanced or metastatic NSCLC who received at least one week of treatment with lorlatinib as part of the French Expanded Access Program (ATU program). Selection period would start at October 2015 (e.g.,initiation of lorlatinib treatment)
Who may be able to join
- Patients with histologically or cytologically confirmed locally advanced or metastatic NSCLC (Stage IIIB or IV accordingly to American Joint Committee on Cancer [AJCC] classification) at time of lorlatinib initiation
- Patients who received at least one week of treatment with lorlatinib as part of the French Expanded Access Program (ATU program); ATU was granted due to their inability to meet eligibility criteria for on-going recruiting trials, inability to participate in other clinical trials (e.g., poor performance status, lack of geographic proximity), or because other medical interventions are not considered appropriate or acceptable.
Who cannot join
- Patients enrolled in a lorlatinib clinical trial
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
France30 sites
Aix-en-Provence - CH
Aix-en-Provence
Angers - CHU
Angers
Annemasse - CH
Annemasse
Avignon - CH
Avignon
Bordeaux - Polyclinique
Bordeaux
Brest - Morvan CHU
Brest
Cahors - CH
Cahors
Chartres-CH
Chartres
Clermont-Ferrand - CHU
Clermont-Ferrand
Colmar - CH
Colmar
Créteil - CHI
Créteil
La Roche-Sur-Yon - CH
La Roche-sur-Yon
Libourne - CH
Libourne
Lorient - CHBS
Lorient
Lyon - CRLCC
Lyon
Marseille - CRLCC
Marseille
Montpellier - ICM
Montpellier
Mulhouse - GHRMSA
Mulhouse
Paris - Curie
Paris
Paris - Saint-Louis
Paris
Paris - Tenon
Paris
Lyon - URCOT
Pierre-Bénite
Reims - CHU
Reims
Saint-Etienne - CHU
Saint-Etienne
Saint-Nazaire - Clinique Mutualiste de l'Estuaire
Saint-Nazaire
Toulouse - CHU
Toulouse
Tours - CHU
Tours
Valenciennes - Clinique
Valenciennes
Vandoeuvre-lès-Nancy - CRLCC
Vandœuvre-lès-Nancy
Villejuif - Gustave Roussy
Villejuif
About this study
Official title: Efficacy of Treatment Sequences in Patients With ALK and ROS-1 Positive Non-small Cell Lung Cancer Who Received Lorlatinib as Part of the French Expanded Access Program
The study will evaluate progression-free survival, overall survival, best response and duration of treatment in patients with advanced ALK- and ROS1-positive non-small cell lung cancer who received lorlatinib as part of the French expanded access program.
Read the detailed description
IFCT-1803 LORLATU study will evaluate progression-free survival, overall survival, best response and duration of treatment in patients with advanced ALK- and ROS1-positive non-small cell lung cancer who received lorlatinib (PF-06463922) as part of the French expanded access program. Those outcomes will be correlated to clinical, pathological, and radiological characteristics of patients.
- Conditions
- Non-small Cell Lung Cancer Metastatic, ALK Gene Rearrangement Positive, ROS-1 Gene Rearrangement Positive
- Keywords
- lorlatinib, Non-small Cell Lung Cancer, IFCT, Real-world study
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
time from first dose of treatment to first occurrence of disease progression or death from any cause during the study
Measured: October 2015 - December 2019
Secondary outcomes (9)
Best response
best response recorded from the start of treatment until disease progression or start of further anti-cancer treatment
Measured: October 2015 - December 2019
Duration of treatment
time from first dose of treatment to discontinuation of treatment or death from any cause during the study
Measured: October 2015 - December 2019
Pattern of tumor progression
site of disease progression after each line of treatment
Measured: October 2015 - December 2019
Reason for treatment discontinuation
this may be disease progression, toxicity, death, other
Measured: October 2015 - December 2019
Duration of treatment beyond progression
time between first occurrence of disease progression and discontinuation the treatment
Measured: October 2015 - December 2019
Central Nervous System (CNS) best response
in patients with CNS measurable lesion, best response on CNS locations recorded from the start of treatment until disease progression or start of further anti-cancer treatment
Measured: October 2015 - December 2019
Central Nervous System (CNS) Progression free survival
time from first dose of treatment to first occurrence of disease progression in the CNS or death from any cause during the study
Measured: October 2015 - December 2019
Overall Survival
is defined as the time from the first dose of treatment dose and death from any cause
Measured: October 2015 - December 2019
Adverse Events
complications of lorlatinib therapy will be recorded
Measured: October 2015 - December 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2018
- Study start1 Feb 2019
- Primary completion12 Oct 2020
- Study completion12 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung Cancer MetastaticStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 291 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intergroupe Francophone de Cancerologie Thoracique
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Nicolas Girard, MD, PhD, Principal investigator, Institut Curie Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03727477
- Sponsor's protocol ID
- IFCT-1803
- Acronym
- LORLATU
- Status last verified
- May 2023
- First submitted
- 29 Oct 2018
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Girard N, Galland-Girodet S, Avrillon V, Besse B, Duruisseaux M, Cadranel J, Otto J, Prevost A, Roch B, Bennouna J, Bouledrak K, Coudurier M, Egenod T, Lamy R, Ricordel C, Moro-Sibilot D, Odier L, Tillon-Strozyk J, Zalcman G, Missy P, Westeel V, Baldacci S. Lorlatinib for advanced ROS1+ non-small-cell lung cancer: results of the IFCT-1803 LORLATU study. ESMO Open. 2022 Apr;7(2):100418. doi: 10.1016/j.esmoop.2022.100418. Epub 2022 Feb 26.
PubMed 35227966Baldacci S, Besse B, Avrillon V, Mennecier B, Mazieres J, Dubray-Longeras P, Cortot AB, Descourt R, Doubre H, Quantin X, Duruisseaux M, Monnet I, Moro-Sibilot D, Cadranel J, Clement-Duchene C, Cousin S, Ricordel C, Merle P, Otto J, Schneider S, Langlais A, Morin F, Westeel V, Girard N. Lorlatinib for advanced anaplastic lymphoma kinase-positive non-small cell lung cancer: Results of the IFCT-1803 LORLATU cohort. Eur J Cancer. 2022 May;166:51-59. doi: 10.1016/j.ejca.2022.01.018. Epub 2022 Mar 9.
PubMed 35278825
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Treatment Sequences in Patients With ALK and ROS-1 Positive Non-small Cell Lung Cancer Who Received Lorlatinib as Part of the French Expanded Access Program
- ClinicalTrials.gov ID
- NCT03727477
- Acronym / sponsor ID
- LORLATU / IFCT-1803
- Conditions
- Non-small Cell Lung Cancer Metastatic, ALK Gene Rearrangement Positive, ROS-1 Gene Rearrangement Positive
- Keywords
- lorlatinib, Non-small Cell Lung Cancer, IFCT, Real-world study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 291 participants (actual)
- Lead sponsor
- Intergroupe Francophone de Cancerologie ThoraciqueUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 12 Oct 2020 (actual)
- Study completion
- 12 Oct 2020 (actual)
- First posted
- 1 Nov 2018 (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.
The study will evaluate progression-free survival, overall survival, best response and duration of treatment in patients with advanced ALK- and ROS1-positive non-small cell lung cancer who received lorlatinib as part of the French expanded access program.
Detailed description
IFCT-1803 LORLATU study will evaluate progression-free survival, overall survival, best response and duration of treatment in patients with advanced ALK- and ROS1-positive non-small cell lung cancer who received lorlatinib (PF-06463922) as part of the French expanded access program. Those outcomes will be correlated to clinical, pathological, and radiological characteristics of patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with histologically or cytologically confirmed locally advanced or metastatic NSCLC who received at least one week of treatment with lorlatinib as part of the French Expanded Access Program (ATU program). Selection period would start at October 2015 (e.g.,initiation of lorlatinib treatment)
Key inclusion criteria (2 listed)
- Patients with histologically or cytologically confirmed locally advanced or metastatic NSCLC (Stage IIIB or IV accordingly to American Joint Committee on Cancer [AJCC] classification) at time of lorlatinib initiation
- Patients who received at least one week of treatment with lorlatinib as part of the French Expanded Access Program (ATU program); ATU was granted due to their inability to meet eligibility criteria for on-going recruiting trials, inability to participate in other clinical trials (e.g., poor performance status, lack of geographic proximity), or because other medical interventions are not considered appropriate or acceptable.
Key exclusion criteria (1 listed)
- Patients enrolled in a lorlatinib clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression free survival
Time frame: October 2015 - December 2019
time from first dose of treatment to first occurrence of disease progression or death from any cause during the study
9 secondary outcomes
Best response
Time frame: October 2015 - December 2019
Duration of treatment
Time frame: October 2015 - December 2019
Pattern of tumor progression
Time frame: October 2015 - December 2019
Reason for treatment discontinuation
Time frame: October 2015 - December 2019
Duration of treatment beyond progression
Time frame: October 2015 - December 2019
Central Nervous System (CNS) best response
Time frame: October 2015 - December 2019
Central Nervous System (CNS) Progression free survival
Time frame: October 2015 - December 2019
Overall Survival
Time frame: October 2015 - December 2019
Adverse Events
Time frame: October 2015 - December 2019
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 24 May 2023.
- Results publication: PubMed 35227966Girard N, Galland-Girodet S, Avrillon V, Besse B, Duruisseaux M, Cadranel J, Otto J, Prevost A, Roch B, Bennouna J, Bouledrak K, Coudurier M, Egenod T, Lamy R, Ricordel C, Moro-Sibilot D, Odier L, Tillon-Strozyk J, Zalcman G, Missy P, Westeel V, Baldacci S. Lorlatinib for advanced ROS1+ non-small-cell lung cancer: results of the IFCT-1803 LORLATU study. ESMO Open. 2022 Apr;7(2):100418. doi: 10.1016/j.esmoop.2022.100418. Epub 2022 Feb 26.
- Results publication: PubMed 35278825Baldacci S, Besse B, Avrillon V, Mennecier B, Mazieres J, Dubray-Longeras P, Cortot AB, Descourt R, Doubre H, Quantin X, Duruisseaux M, Monnet I, Moro-Sibilot D, Cadranel J, Clement-Duchene C, Cousin S, Ricordel C, Merle P, Otto J, Schneider S, Langlais A, Morin F, Westeel V, Girard N. Lorlatinib for advanced anaplastic lymphoma kinase-positive non-small cell lung cancer: Results of the IFCT-1803 LORLATU cohort. Eur J Cancer. 2022 May;166:51-59. doi: 10.1016/j.ejca.2022.01.018. Epub 2022 Mar 9.
- 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.
Nicolas Girard, MD, PhD principal investigator
Institut Curie Paris
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer Metastatic and ALK Gene Rearrangement Positive, run by Intergroupe Francophone de Cancerologie Thoracique at 30 sites in France.
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 2 inclusion and 1 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 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in France. 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: October 2015 - December 2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03727477, which also lists 2 linked publications.
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 24 May 2023.