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Tests treatment safety and results for ALK+ Non-Small-Cell Lung Carcinoma
Official title Analysis of the Effectiveness and Safety of Lorlatinib in Untreated ALK-Positive NSCLC Patients in a French Real-World Context
ClinicalTrials.gov ID: NCT06487078
What this study is testing
What is Lorlatinib?
Lorlatinib is an investigational medicine, being studied as a potential treatment for alk+ non-small-cell lung carcinoma.
Also referred to as PF-06463922.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Analysis of the Effectiveness and Safety of Lorlatinib in Untreated ALK-Positive NSCLC Patients in a French Real-World context
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Complete radiological evaluation has to be performed before the start of lorlatinib by contrast enhanced CT-scan of thorax and upper abdomen and...
- Patients with ECOG performance status grade 0, 1, or 2
You likely can't join if
- 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...
- Patients who have previously received adjuvant ALK TKI therapy (unless metastatic relapse occurs more than one year after completion of adjuvant...
- 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
See the full eligibility 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
- 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...
- 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-treatment) clinical study or during the follow-up period of an treatment 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...
The study team makes the final eligibility decision.
Where it's taking place
- Paris, Paris, France
- Aix-en-Provence, France
- Albi, France
- Amiens, France
- Avignon, France
- Bordeaux, France
- Brest, France
- Créteil, France
- Dijon, France
- Gleizé, France
- Limoges, France
- Lyon, France
- Metz, France
- Nancy, France
- Nantes, France
- Paris, France
- Pau, France
- Pringy, France
- Quimper, France
- Reims, France
+ 8 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, Paris, France; Aix-en-Provence, France; Albi, France; Amiens, France; Avignon, France; Bordeaux, France and 22 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.