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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

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

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival | time from first dose of treatment to first occurrence of disease progression or death from any cause during the study | October 2015 - December 2019 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best response | best response recorded from the start of treatment until disease progression or start of further anti-cancer treatment | October 2015 - December 2019 | 
| Duration of treatment | time from first dose of treatment to discontinuation of treatment or death from any cause during the study | October 2015 - December 2019 | 
| Pattern of tumor progression | site of disease progression after each line of treatment | October 2015 - December 2019 | 
| Reason for treatment discontinuation | this may be disease progression, toxicity, death, other | October 2015 - December 2019 | 
| Duration of treatment beyond progression | time between first occurrence of disease progression and discontinuation the treatment | October 2015 - December 2019 | 
| Central Nervous System (CNS) best response | in patients with CNS measurable lesion, best response on CNS locations recorded from the start of treatment until disease progression or start of further anti-cancer treatment | October 2015 - December 2019 | 
| Central Nervous System (CNS) Progression free survival | time from first dose of treatment to first occurrence of disease progression in the CNS or death from any cause during the study | October 2015 - December 2019 | 
| Overall Survival | is defined as the time from the first dose of treatment dose and death from any cause | October 2015 - December 2019 | 
| Adverse Events | complications of lorlatinib therapy will be recorded | October 2015 - December 2019 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IFCT, lorlatinib, Non-small Cell Lung Cancer, Real-world study