NCT06487078 Analysis of the Effectiveness and Safety of Lorlatinib in Untreated ALK-Positive NSCLC Patients in a French Real-World Context
| NCT ID | NCT06487078 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pfizer |
| Condition | ALK+ Non-Small-Cell Lung Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-01-20 |
| Primary Completion | 2028-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2025-01-20 with a primary completion date of 2028-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Analysis of the Effectiveness and Safety of Lorlatinib in Untreated ALK-Positive NSCLC Patients in a French Real-World context
Eligibility 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.
Contact & Investigator
Pfizer CT.gov Call Center
STUDY DIRECTOR
Pfizer
Frequently Asked Questions
Who can join the NCT06487078 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying ALK+ Non-Small-Cell Lung Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06487078 currently recruiting?
Yes, NCT06487078 is actively recruiting participants. Contact the research team at ClinicalTrials.gov_Inquiries@pfizer.com for enrollment information.
Where is the NCT06487078 trial being conducted?
This trial is being conducted at Paris, France, Aix-en-Provence, France, Albi, France, Amiens, France and 11 additional locations.
Who is sponsoring the NCT06487078 clinical trial?
NCT06487078 is sponsored by Pfizer. The principal investigator is Pfizer CT.gov Call Center at Pfizer. The trial plans to enroll 90 participants.