Efficacy of Treatment Sequences in Patients With Non-small Cell Lung Cancer Receiving Lorlatinib
NCT03727477
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Adult Trials: 18+ Years
- 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.
- Patients enrolled in a lorlatinib clinical trial
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Efficacy of Treatment Sequences in Patients With Non-small Cell Lung Cancer Receiving Lorlatinib | |||
| Official Title | 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 | |||
| 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. | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Cohort Time Perspective: Retrospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Non-Probability Sample | |||
| Study Population | Patients with histologically or cytologically confirmed locally advanced or metastatic NSCLC who received at least one week of treatment with lorlatinib as part of the French Expanded Access Program (ATU program). Selection period would start at October 2015 (e.g.,initiation of lorlatinib treatment) | |||
| Condition |
| |||
| Intervention | Not Provided | |||
| Study Groups/Cohorts | Not Provided | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status | Completed | |||
| Actual Enrollment | 291 | |||
| Original Estimated Enrollment | 300 | |||
| Actual Study Completion Date | October 12, 2020 | |||
| Actual Primary Completion Date | October 12, 2020 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender |
| |||
| Ages | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | France | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT03727477 | |||
| Other Study ID Numbers | IFCT-1803 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement |
| |||
| Responsible Party | Intergroupe Francophone de Cancerologie Thoracique | |||
| Study Sponsor | Intergroupe Francophone de Cancerologie Thoracique | |||
| Collaborators | Pfizer | |||
| Investigators |
| |||
| PRS Account | Intergroupe Francophone de Cancerologie Thoracique | |||
| Verification Date | February 2020 | |||