Analysis of the Effectiveness and Safety of Lorlatinib in Untreated ALK-Positive NSCLC Patients in a French Real-World context
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
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.
known strong CYP3A inhibitors
Single group
Lorlatinib
DrugALK-positive NSCL treatment
Progression-Free Survival (PFS)
Time from inclusion to date of disease progression or death of any cause whichever occurs first.
Overall Survival (OS)
Time from inclusion to date of death from any cause.
Objective Response Rate (ORR)
proportion of patients with a Complete Response (CR) or Partial Response (PR) as a best response during the lorlatinib treatment. Responses to treatment will be defined according to investigator
Duration of Response (DR)
time between the first documentation of objective response and the first documentation of disease progression or death from any cause whichever occurred first, for participants with a confirmed objective response of CR or PR.
Intracranial Objective Response Rate (IC-ORR)
proportion of patients with intracranial objective response of complete response (CR) or partial response (PR) as a best response in the subset of patients with at least 1 intracranial lesion assessed by investigator.
