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Analysis of the Effectiveness and Safety of Lorlatinib in Untreated ALK-Positive NSCLC Patients in a French Real-World Context | Clinical Trials | Clareo Health

RECRUITINGNA

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

LOREA: ANALYSIS OF THE EFFECTIVENESS AND SAFETY OF LORLATINIB IN UNTREATED ALK-POSITIVE NSCLC PATIENTS IN A FRENCH REAL-WORLD CONTEXT

NCT06487078•Pfizer

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

•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
+8 more criteria

Locations (1)

Institut Godinot

Reims, France

Key Dates

Start Date

January 20, 2025

Primary Completion Date

November 30, 2028

Completion Date

November 30, 2028

Last Updated

March 25, 2025

Enrollment

ESTIMATED participants

Conditions

ALK+ Non-Small-Cell Lung Carcinoma

Interventions

Lorlatinib

DRUG

Contacts

Pfizer CT.gov Call Center

CONTACT

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