Actively Recruiting
Analysis of the Effectiveness and Safety of Lorlatinib in Untreated ALK-Positive NSCLC Patients in a French Real-World Context
Led by Pfizer · Updated on 2026-05-06
90
Participants Needed
31
Research Sites
201 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Analysis of the Effectiveness and Safety of Lorlatinib in Untreated ALK-Positive NSCLC Patients in a French Real-World context
CONDITIONS
Official Title
Analysis of the Effectiveness and Safety of Lorlatinib in Untreated ALK-Positive NSCLC Patients in a French Real-World Context
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years of age or older at inclusion
- Histologically or cytologically confirmed locally advanced or metastatic ALK-positive NSCLC
- Complete radiological evaluation before lorlatinib treatment including contrast-enhanced CT scan of thorax and upper abdomen and brain MRI
- ECOG performance status of 0, 1, or 2
You will not qualify if you...
- Active malignancy within the last 2 years prior to inclusion except certain specified cancers
- Prior adjuvant ALK TKI therapy unless metastatic relapse occurs more than one year after completion
- Previous systemic therapy for metastatic NSCLC
- Use of known strong CYP3A inhibitors, strong CYP3A inducers, or P-gp substrates with narrow therapeutic index within 12 days before lorlatinib
- Medical or psychiatric conditions that increase risk or make participation inappropriate
- Positive pregnancy test for females of childbearing potential
- Breastfeeding or unwilling/unable to use highly effective contraception for females of childbearing potential during and 35 days after treatment
- Fertile males unwilling/unable to use highly effective contraception during and 97 days after treatment
- Participation in another clinical study except observational or follow-up period of interventional study
- Deprivation of liberty, protective custody, guardianship, or inability to provide signed consent
- Not affiliated with French social security system
- Opposition to data collection
- Inability to comply with study protocol including treatment and visits
- Inaptitude to respond due to linguistic, psychological, social, or geographical reasons
- Investigator site staff involved in the study and their family members
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 31 locations
1
Institut Curie
Paris, Paris, France, 75005
Actively Recruiting
2
Centre Hospitalier du Pays d AIX
Aix-en-Provence, France, 13100
Actively Recruiting
3
CH ALBI
Albi, France, 81000
Actively Recruiting
4
Chu Amiens Sud
Amiens, France, 80000
Actively Recruiting
5
Ch Avignon
Avignon, France, 84000
Not Yet Recruiting
6
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, France, 30072
Not Yet Recruiting
7
Institut Bergonie
Bordeaux, France, 33076
Not Yet Recruiting
8
Hopital Morvan
Brest, France, 29000
Not Yet Recruiting
9
CHIC
Créteil, France, 94010
Actively Recruiting
10
Clcc Georges Francois Leclerc
Dijon, France, 21000
Actively Recruiting
11
Hopital de Villefranche Sur Saone
Gleizé, France, 69400
Not Yet Recruiting
12
Chu Limoges
Limoges, France, 87042
Actively Recruiting
13
Centre Leon Berard
Lyon, France, 69373
Not Yet Recruiting
14
Hopital Robert Schuman de Vantoux
Metz, France, 57070
Actively Recruiting
15
CHRU de Nancy
Nancy, France, 54035
Not Yet Recruiting
16
CHU Nantes
Nantes, France, 44093
Actively Recruiting
17
Hopital Cochin
Paris, France, 75014
Not Yet Recruiting
18
Hopital Saint Joseph
Paris, France, 75674
Actively Recruiting
19
Hopital Europeen Georges Pompidou
Paris, France, 75908
Actively Recruiting
20
Centre Hospitalier Francois Mitterand
Pau, France, 64046
Actively Recruiting
21
Ch Annecy Genevois
Pringy, France, 74374
Actively Recruiting
22
Ch Cornouaille
Quimper, France, 29107
Actively Recruiting
23
Institut Godinot
Reims, France, 51056
Actively Recruiting
24
Hopital Pontchaillou
Rennes, France, 35033
Actively Recruiting
25
Hopital Foch
Suresnes, France, 92151
Actively Recruiting
26
Chits Ch Sainte Musse
Toulon, France, 83000
Not Yet Recruiting
27
CHRU Bretonneau
Tours, France, 37000
Actively Recruiting
28
Ch Troyes
Troyes, France, 10003
Actively Recruiting
29
Hopital de Rangueil
TSA 50032 Toulouse, France, 31059
Actively Recruiting
30
Clinique Teissier
Valenciennes, France, 59300
Actively Recruiting
31
CHBA
Vannes, France, 56017
Actively Recruiting
Research Team
P
Pfizer CT.gov Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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