Efficacy of Treatment Sequences in Patients With Non-small Cell Lung Cancer Receiving Lorlatinib (LORLATU)

Intergroupe Francophone de Cancerologie Thoracique

Status: Completed

Conditions: ALK Gene Rearrangement Positive; ROS-1 Gene Rearrangement Positive; Non-small Cell Lung Cancer Metastatic

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03727477

IFCT-1803

Details and patient eligibility

About

The study will evaluate progression-free survival, overall survival, best response and duration of treatment in patients with advanced ALK- and ROS1-positive non-small cell lung cancer who received lorlatinib as part of the French expanded access program.

Full description

IFCT-1803 LORLATU study will evaluate progression-free survival, overall survival, best response and duration of treatment in patients with advanced ALK- and ROS1-positive non-small cell lung cancer who received lorlatinib (PF-06463922) as part of the French expanded access program. Those outcomes will be correlated to clinical, pathological, and radiological characteristics of patients.

Enrollment: 291 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with histologically or cytologically confirmed locally advanced or metastatic NSCLC (Stage IIIB or IV accordingly to American Joint Committee on Cancer [AJCC] classification) at time of lorlatinib initiation
• Patients who received at least one week of treatment with lorlatinib as part of the French Expanded Access Program (ATU program); ATU was granted due to their inability to meet eligibility criteria for on-going recruiting trials, inability to participate in other clinical trials (e.g., poor performance status, lack of geographic proximity), or because other medical interventions are not considered appropriate or acceptable.

Exclusion criteria

• Patients enrolled in a lorlatinib clinical trial