ALK Gene Rearrangement Positive, Non-small Cell Lung Cancer Metastatic, ROS-1 Gene Rearrangement Positive
Conditions
Keywords
lorlatinib, Non-small Cell Lung Cancer, IFCT, Real-world study
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.
Interventions
None listed
Sponsors
Pfizer
Intergroupe Francophone de Cancerologie Thoracique
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival | 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
| Measure | Time frame | Description |
|---|---|---|
| Duration of treatment | October 2015 - December 2019 | time from first dose of treatment to discontinuation of treatment or death from any cause during the study |
| Pattern of tumor progression | October 2015 - December 2019 | site of disease progression after each line of treatment |
| Reason for treatment discontinuation | October 2015 - December 2019 | this may be disease progression, toxicity, death, other |
| Duration of treatment beyond progression | October 2015 - December 2019 | time between first occurrence of disease progression and discontinuation the treatment |
| Best response | October 2015 - December 2019 | best response recorded from the start of treatment until disease progression or start of further anti-cancer treatment |
| Central Nervous System (CNS) Progression free survival | October 2015 - December 2019 | time from first dose of treatment to first occurrence of disease progression in the CNS or death from any cause during the study |
| Overall Survival | October 2015 - December 2019 | is defined as the time from the first dose of treatment dose and death from any cause |
| Adverse Events | October 2015 - December 2019 | complications of lorlatinib therapy will be recorded |
| Central Nervous System (CNS) best response | October 2015 - December 2019 | 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 |
Countries
France
Outcome results
None listed