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Effectiveness and safety of Lorlatinib for untreated ALK-positive lung cancer patients in France

LOREA : ANALYSIS OF THE EFFECTIVENESS AND SAFETY OF LORLATINIB IN UNTREATED ALK-POSITIVE NSCLC PATIENTS IN A FRENCH NON INTERVENTIONAL STUDY

Not applicable Interventional Pfizer · NCT06487078

This study is testing if Lorlatinib is safe and effective for adults in France who have not yet received treatment for ALK-positive lung cancer.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment90 (estimated)
Ages18 Years and up
SexAll
SponsorPfizer Industry-sponsored
Drugs / interventionslorlatinib
Locations31 sites (Paris, Paris and 30 other locations)
Trial IDNCT06487078 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness and safety of Lorlatinib in patients with untreated ALK-positive non-small-cell lung carcinoma (NSCLC) in a real-world setting in France. Participants must be adults with a confirmed diagnosis of locally advanced or metastatic ALK-positive NSCLC and an ECOG performance status of 0, 1, or 2. The study involves a complete radiological evaluation before treatment initiation to ensure proper patient selection. The findings aim to provide insights into the drug's performance outside of controlled clinical trial environments.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with untreated, histologically confirmed ALK-positive NSCLC.

Not a fit: Patients with active malignancies other than specified low-risk cancers or those with poor ECOG performance status may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable information on the effectiveness of Lorlatinib, potentially leading to improved treatment options for patients with ALK-positive NSCLC.

How similar studies have performed: Other studies have shown promising results with Lorlatinib in similar patient populations, indicating a potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Paris, Paris and 30 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions ALK+ Non-Small-Cell Lung Carcinoma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.