Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06487078

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

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

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here