Efficacy of Treatment Sequences in Patients With ALK and ROS-1 Positive Non-small Cell Lung Cancer Who Received Lorlatinib as Part of the French Expanded Access Program
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Non-small Cell Lung Cancer Metastatic
- Sponsor
- Intergroupe Francophone de Cancerologie Thoracique
- Enrollment
- 291
- Locations
- 30
- Primary Endpoint
- Progression free survival
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Progression free survival
Time Frame: October 2015 - December 2019
time from first dose of treatment to first occurrence of disease progression or death from any cause during the study
Secondary Outcomes
- Duration of treatment(October 2015 - December 2019)
- Best response(October 2015 - December 2019)
- Duration of treatment beyond progression(October 2015 - December 2019)
- Overall Survival(October 2015 - December 2019)
- Pattern of tumor progression(October 2015 - December 2019)
- Central Nervous System (CNS) best response(October 2015 - December 2019)
- Adverse Events(October 2015 - December 2019)
- Reason for treatment discontinuation(October 2015 - December 2019)
- Central Nervous System (CNS) Progression free survival(October 2015 - December 2019)