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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | time from first dose of treatment to first occurrence of disease progression or death from any cause during the study | October 2015 - December 2019 |
| Measure | Description | Time Frame |
|---|---|---|
| Best response | best response recorded from the start of treatment until disease progression or start of further anti-cancer treatment | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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)
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| Name | Affiliation | Role |
|---|---|---|
| Nicolas Girard, MD, PhD | Institut Curie Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aix-en-Provence - CH | Aix-en-Provence | France | ||||
| Angers - CHU |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35227966 | Result | 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. | |
| 35278825 |
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| October 2015 - December 2019 |
| Pattern of tumor progression | site of disease progression after each line of treatment | October 2015 - December 2019 |
| Reason for treatment discontinuation | this may be disease progression, toxicity, death, other | October 2015 - December 2019 |
| Duration of treatment beyond progression | time between first occurrence of disease progression and discontinuation the treatment | 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 | 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 | October 2015 - December 2019 |
| Overall Survival | is defined as the time from the first dose of treatment dose and death from any cause | October 2015 - December 2019 |
| Adverse Events | complications of lorlatinib therapy will be recorded | October 2015 - December 2019 |
| Angers |
| France |
| Annemasse - CH | Annemasse | France |
| Avignon - CH | Avignon | France |
| Bordeaux - Polyclinique | Bordeaux | France |
| Brest - Morvan CHU | Brest | France |
| Cahors - CH | Cahors | France |
| Chartres-CH | Chartres | France |
| Clermont-Ferrand - CHU | Clermont-Ferrand | France |
| Colmar - CH | Colmar | France |
| Créteil - CHI | Créteil | France |
| La Roche-Sur-Yon - CH | La Roche-sur-Yon | France |
| Libourne - CH | Libourne | France |
| Lorient - CHBS | Lorient | France |
| Lyon - CRLCC | Lyon | France |
| Marseille - CRLCC | Marseille | France |
| Montpellier - ICM | Montpellier | France |
| Mulhouse - GHRMSA | Mulhouse | France |
| Paris - Curie | Paris | France |
| Paris - Saint-Louis | Paris | France |
| Paris - Tenon | Paris | France |
| Lyon - URCOT | Pierre-Bénite | France |
| Reims - CHU | Reims | France |
| Saint-Etienne - CHU | Saint-Etienne | France |
| Saint-Nazaire - Clinique Mutualiste de l'Estuaire | Saint-Nazaire | France |
| Toulouse - CHU | Toulouse | France |
| Tours - CHU | Tours | France |
| Valenciennes - Clinique | Valenciennes | France |
| Vandoeuvre-lès-Nancy - CRLCC | Vandœuvre-lès-Nancy | France |
| Villejuif - Gustave Roussy | Villejuif | France |
| Result |
| Baldacci 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. |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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