Informations générales (source: ClinicalTrials.gov)
LOREA: ANALYSIS OF THE EFFECTIVENESS AND SAFETY OF LORLATINIB IN UNTREATED ALK-POSITIVE NSCLC PATIENTS IN A FRENCH REAL-WORLD CONTEXT
Interventional
N/A
Pfizer (Voir sur ClinicalTrials)
janvier 2025
novembre 2028
11 septembre 2025
Analysis of the Effectiveness and Safety of Lorlatinib in Untreated ALK-Positive NSCLC
Patients in a French Real-World context
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FOCH | Jaafar BENNOUNA | 15/12/2025 08:26:55 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Institut Godinot - 51056 - Reims Cedex - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria: Participants are eligible to be included in the study only if all the
following criteria apply:
- Patients (male or female) 18 years of age or older at age inclusion
- Patients with histologically or cytologically confirmed diagnosis of locally
advanced or metastatic (TNM 8th classification) ALK-positive NSCLC (IHC 3+/FISH
positive/transcriptomic method)
- Complete radiological evaluation has to be performed before the start of lorlatinib
by contrast enhanced CT-scan of thorax and upper abdomen and brain MRI, as per
routine care
- Patients with ECOG performance status grade 0, 1, or 2
following criteria apply:
- Patients (male or female) 18 years of age or older at age inclusion
- Patients with histologically or cytologically confirmed diagnosis of locally
advanced or metastatic (TNM 8th classification) ALK-positive NSCLC (IHC 3+/FISH
positive/transcriptomic method)
- Complete radiological evaluation has to be performed before the start of lorlatinib
by contrast enhanced CT-scan of thorax and upper abdomen and brain MRI, as per
routine care
- Patients with ECOG performance status grade 0, 1, or 2
Participants are excluded from the study if any of the following
criteria Apply
- Evidence of active malignancy within the last 2 years prior to inclusion (other than
NSCLC, non-melanoma skin cancer, cervical in situ cancer, papillary thyroid cancer,
lobular carcinoma in situ/ductal carcinoma in situ (LCIS/DCIS) of the breast, or
localized prostate cancer).
- Patients who have previously received adjuvant ALK TKI therapy (unless metastatic
relapse occurs more than one year after completion of adjuvant therapy).
- Patients who have previously received systemic NSCLC therapy in metastatic
condition.
- Patients using any of the following food or drugs within 12 days prior to the first
dose of lorlatinib:
- known strong CYP3A inhibitors
- known strong CYP3A inducers
- known P gp substrates with a narrow therapeutic index
- Patients with any medical or psychiatric condition, or that may, in the
investigator's judgment, increase the risk of study participation or make the
participant inappropriate for the study.
- Positive pregnancy test for females of childbearing potential.
- Breastfeeding and childbearing potential female unwilling/unable to use a highly
effective contraception method for the study duration and for at least 35 days after
the last dose of lorlatinib
- Fertile male patients unwilling/unable to use a highly effective method of
contraception for the duration of the study and for at least 97 days after the last
dose of lorlatinib.
- Patients participating in another clinical study, unless it is an observational
(non-interventional) clinical study or during the follow-up period of an
interventional study.
- Patients deprived of their liberty, under protective custody or guardianship or
unable to provide signed consent.
- Patients not affiliated to the French social security system.
- Patients opposed to the collection of their data.
- Patients willing and able to comply with the protocol for the duration of the study
including undergoing treatment, scheduled visits and examinations including
follow-up.
- Patients judged inapt to respond to the questions required for the study due to
linguistical, psychological, social, or geographical reasons.
- Investigator site staff directly involved in the conduct of the study and their
family members, site staff otherwise supervised by the investigator, and sponsor and
sponsor delegate employees directly involved in the conduct of the study and their
family members.
criteria Apply
- Evidence of active malignancy within the last 2 years prior to inclusion (other than
NSCLC, non-melanoma skin cancer, cervical in situ cancer, papillary thyroid cancer,
lobular carcinoma in situ/ductal carcinoma in situ (LCIS/DCIS) of the breast, or
localized prostate cancer).
- Patients who have previously received adjuvant ALK TKI therapy (unless metastatic
relapse occurs more than one year after completion of adjuvant therapy).
- Patients who have previously received systemic NSCLC therapy in metastatic
condition.
- Patients using any of the following food or drugs within 12 days prior to the first
dose of lorlatinib:
- known strong CYP3A inhibitors
- known strong CYP3A inducers
- known P gp substrates with a narrow therapeutic index
- Patients with any medical or psychiatric condition, or that may, in the
investigator's judgment, increase the risk of study participation or make the
participant inappropriate for the study.
- Positive pregnancy test for females of childbearing potential.
- Breastfeeding and childbearing potential female unwilling/unable to use a highly
effective contraception method for the study duration and for at least 35 days after
the last dose of lorlatinib
- Fertile male patients unwilling/unable to use a highly effective method of
contraception for the duration of the study and for at least 97 days after the last
dose of lorlatinib.
- Patients participating in another clinical study, unless it is an observational
(non-interventional) clinical study or during the follow-up period of an
interventional study.
- Patients deprived of their liberty, under protective custody or guardianship or
unable to provide signed consent.
- Patients not affiliated to the French social security system.
- Patients opposed to the collection of their data.
- Patients willing and able to comply with the protocol for the duration of the study
including undergoing treatment, scheduled visits and examinations including
follow-up.
- Patients judged inapt to respond to the questions required for the study due to
linguistical, psychological, social, or geographical reasons.
- Investigator site staff directly involved in the conduct of the study and their
family members, site staff otherwise supervised by the investigator, and sponsor and
sponsor delegate employees directly involved in the conduct of the study and their
family members.