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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• CHU de Toulouse - Hopital Larrey
  Toulouse, Haute-garonne, France Recruiting
• Institut Curie
  Paris, Paris, France Recruiting
• Centre Hospitalier du Pays d AIX
  Aix-en-Provence, France Recruiting
• Ch Albi
  Albi, France Recruiting
• Chu Amiens Sud
  Amiens, France Recruiting
• Chic
  Créteil, France Recruiting

Study contacts

• Study coordinator: Pfizer CT.gov Call Center
• Email: ClinicalTrials.gov_Inquiries@pfizer.com
• Phone: 1-800-718-1021

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• NXP900 with Lorlatinib in ALK-positive NSCLC

  This study tests whether adding NXP900 to lorlatinib helps people with ALK-positive non-small cell lung cancer who have already received prior therapy.

  Recruiting Phase 1 Nuvectis Pharma, Inc. · Fairfax, Virginia · NCT07784959

• See if tirzepatide helps with lorlatinib-related weight gain in NSCLC patients

  This study tests whether tirzepatide can reduce rapid weight gain in adults with non-small cell lung cancer who are already taking lorlatinib.

  Recruiting Phase 1 University of Chicago · Chicago, Illinois · NCT07782359

• Vortioxetine for cognitive problems in ALK/ROS1-positive NSCLC treated with lorlatinib

  This observational study tests whether vortioxetine can help with cognitive and neurological side effects in adults with ALK/ROS1-positive NSCLC who are taking lorlatinib.

  Recruiting Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo · Bogotá · NCT07633626

• Lorlatinib with local consolidation therapy for ALK-positive advanced non-small cell lung cancer

  This trial will test whether adding local consolidation treatments to lorlatinib helps people with ALK-positive advanced non-small cell lung cancer stay progression-free longer.

  Recruiting Phase 2 M.D. Anderson Cancer Center · Houston, Texas · NCT07415005

• Iruplinalkib for ALK-positive advanced lung adenocarcinoma after lorlatinib

  We will try iruplinalkib in adults with advanced ALK-positive lung adenocarcinoma who progressed on or couldn't tolerate lorlatinib to see how well it works and how safe it is in routine care.

  Recruiting Peking University Shenzhen Hospital · Shenzhen, Guangdong · NCT07374614

• Combining chemotherapy with Lorlatinib for ALK positive lung cancer

  This study is testing if combining chemotherapy with Lorlatinib can help people with ALK positive lung cancer who have seen their disease get worse while on Lorlatinib.

  Recruiting Phase 2 Centro di Riferimento Oncologico - Aviano · Aviano and 8 other locations · NCT06378892

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.