NCT06487078

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
31mo left

Started Jan 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

31 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress34%
Jan 2025Nov 2028

First Submitted

Initial submission to the registry

June 5, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 5, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

January 20, 2025

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2028

Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

3.9 years

First QC Date

June 5, 2024

Last Update Submit

May 5, 2026

Conditions

ALK+ Non-Small-Cell Lung Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Progression-Free Survival (PFS)

    Time from inclusion to date of disease progression or death of any cause whichever occurs first.

    From time of Study Start up to 25 months

Secondary Outcomes (17)

  • Overall Survival (OS)

    From time of Study Start up to 25 months

  • Objective Response Rate (ORR)

    From time of Study Start up to 24 months

  • Duration of Response (DR)

    From time of Study Start up to 24 months

  • Intracranial Objective Response Rate (IC-ORR)

    From time of Study Start up to 24 months

  • Intracranial Time to Progression (IC-TTP)

    From time of Study Start up to 24 months

  • +12 more secondary outcomes

Study Arms (1)

Lorlatinib

EXPERIMENTAL

Lorlatinib single agent, 100 mg (4 x 25 mg) oral tables, QD, continuously

Drug: Lorlatinib

Interventions

LorlatinibDRUG

ALK-positive NSCL treatment

Also known as: PF-06463922
Lorlatinib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (31)

Institut Curie

Paris, Paris, 75005, France

RECRUITING

Centre Hospitalier du Pays d AIX

Aix-en-Provence, 13100, France

RECRUITING

CH ALBI

Albi, 81000, France

RECRUITING

Chu Amiens Sud

Amiens, 80000, France

RECRUITING

Ch Avignon

Avignon, 84000, France

NOT YET RECRUITING

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, 30072, France

NOT YET RECRUITING

Institut Bergonie

Bordeaux, 33076, France

NOT YET RECRUITING

Hopital Morvan

Brest, 29000, France

NOT YET RECRUITING

CHIC

Créteil, 94010, France

RECRUITING

Clcc Georges Francois Leclerc

Dijon, 21000, France

RECRUITING

Hopital de Villefranche Sur Saone

Gleizé, 69400, France

NOT YET RECRUITING

Chu Limoges

Limoges, 87042, France

RECRUITING

Centre Leon Berard

Lyon, 69373, France

NOT YET RECRUITING

Hopital Robert Schuman de Vantoux

Metz, 57070, France

RECRUITING

CHRU de Nancy

Nancy, 54035, France

NOT YET RECRUITING

CHU Nantes

Nantes, 44093, France

RECRUITING

Hopital Cochin

Paris, 75014, France

NOT YET RECRUITING

Hopital Saint Joseph

Paris, 75674, France

RECRUITING

Hopital Europeen Georges Pompidou

Paris, 75908, France

RECRUITING

Centre Hospitalier Francois Mitterand

Pau, 64046, France

RECRUITING

Ch Annecy Genevois

Pringy, 74374, France

RECRUITING

Ch Cornouaille

Quimper, 29107, France

RECRUITING

Institut Godinot

Reims, 51056, France

RECRUITING

Hopital Pontchaillou

Rennes, 35033, France

RECRUITING

Hopital Foch

Suresnes, 92151, France

RECRUITING

Chits Ch Sainte Musse

Toulon, 83000, France

NOT YET RECRUITING

CHRU Bretonneau

Tours, 37000, France

RECRUITING

Ch Troyes

Troyes, 10003, France

RECRUITING

Hopital de Rangueil

TSA 50032 Toulouse, 31059, France

RECRUITING

Clinique Teissier

Valenciennes, 59300, France

RECRUITING

CHBA

Vannes, 56017, France

RECRUITING

Related Links

MeSH Terms

Interventions

lorlatinib

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2024

First Posted

July 5, 2024

Study Start

January 20, 2025

Primary Completion (Estimated)

November 30, 2028

Study Completion (Estimated)

November 30, 2028

Last Updated

May 6, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Locations

FR(31)