Analysis of the Effectiveness and Safety of Lorlatinib in Untreated ALK-Positive NSCLC Patients i… (NCT06487078) | Clinical Trial Compass
RecruitingNot Applicable
Analysis of the Effectiveness and Safety of Lorlatinib in Untreated ALK-Positive NSCLC Patients in a French Real-World Context
France90 participantsStarted 2025-01-20
Plain-language summary
Analysis of the Effectiveness and Safety of Lorlatinib in Untreated ALK-Positive NSCLC Patients in a French Real-World context
Who can participate
Age range18 Years
SexALL
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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 o…
What they're measuring
1
Progression-Free Survival (PFS)
Timeframe: From time of Study Start up to 25 months