Ireland
--:--IST
Recruiting Not applicable

Analysis of the Effectiveness and Safety of Lorlatinib in Untreated ALK-Positive NSCLC Patients in a French Real-World Context

NCT06487078 · tracked via the Priya Life Science France tracker
Sponsor
Phase
Not applicable
Started
2025-01-20
Last updated
2026-05-06

Condition(s) studied

ALK+ Non-Small-Cell Lung Carcinoma

Investigational drug(s) / intervention(s)

Lorlatinib →

Lorlatinib: ALK-positive NSCL treatment

Study summary

Analysis of the Effectiveness and Safety of Lorlatinib in Untreated ALK-Positive NSCLC Patients in a French Real-World context

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 Exclusion Criteria: 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.

Primary outcome measure(s)

  • Progression-Free Survival (PFS) — From time of Study Start up to 25 months
    Time from inclusion to date of disease progression or death of any cause whichever occurs first.

Trial sites (31)

FacilityCityRegionStatus
Institut Curie Paris Paris Recruiting
Centre Hospitalier du Pays d AIX Aix-en-Provence France Recruiting
CH ALBI Albi France Recruiting
Chu Amiens Sud Amiens France Recruiting
Ch Avignon Avignon France Not Yet Recruiting
Polyclinique Bordeaux Nord Aquitaine Bordeaux France Not Yet Recruiting
Institut Bergonie Bordeaux France Not Yet Recruiting
Hopital Morvan Brest France Not Yet Recruiting
CHIC Créteil France Recruiting
Clcc Georges Francois Leclerc Dijon France Recruiting
Hopital de Villefranche Sur Saone Gleizé France Not Yet Recruiting
Chu Limoges Limoges France Recruiting
Centre Leon Berard Lyon France Not Yet Recruiting
Hopital Robert Schuman de Vantoux Metz France Recruiting
CHRU de Nancy Nancy France Not Yet Recruiting
CHU Nantes Nantes France Recruiting
Hopital Cochin Paris France Not Yet Recruiting
Hopital Saint Joseph Paris France Recruiting
Hopital Europeen Georges Pompidou Paris France Recruiting
Centre Hospitalier Francois Mitterand Pau France Recruiting
Ch Annecy Genevois Pringy France Recruiting
Ch Cornouaille Quimper France Recruiting
Institut Godinot Reims France Recruiting
Hopital Pontchaillou Rennes France Recruiting
Hopital Foch Suresnes France Recruiting
Chits Ch Sainte Musse Toulon France Not Yet Recruiting
CHRU Bretonneau Tours France Recruiting
Ch Troyes Troyes France Recruiting
Hopital de Rangueil TSA 50032 Toulouse France Recruiting
Clinique Teissier Valenciennes France Recruiting
CHBA Vannes France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06487078 on ClinicalTrials.gov ↗ ← All trials in France