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Trial record 1 of 1 for:    NCT03727477
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Efficacy of Treatment Sequences in Patients With Non-small Cell Lung Cancer Receiving Lorlatinib (LORLATU)

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ClinicalTrials.gov Identifier: NCT03727477
Recruitment Status : Completed
First Posted : November 1, 2018
Last Update Posted : October 20, 2020
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Intergroupe Francophone de Cancerologie Thoracique

Tracking Information
First Submitted Date October 29, 2018
First Posted Date November 1, 2018
Last Update Posted Date October 20, 2020
Actual Study Start Date February 1, 2019
Actual Primary Completion Date October 12, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 30, 2018)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 30, 2018)
  • Best response [ Time Frame: October 2015 - December 2019 ]
    best response recorded from the start of treatment until disease progression or start of further anti-cancer treatment
  • Duration of treatment [ Time Frame: 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 [ Time Frame: October 2015 - December 2019 ]
    site of disease progression after each line of treatment
  • Reason for treatment discontinuation [ Time Frame: October 2015 - December 2019 ]
    this may be disease progression, toxicity, death, other
  • Duration of treatment beyond progression [ Time Frame: October 2015 - December 2019 ]
    time between first occurrence of disease progression and discontinuation the treatment
  • Central Nervous System (CNS) best response [ Time Frame: 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
  • Central Nervous System (CNS) Progression free survival [ Time Frame: 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 [ Time Frame: October 2015 - December 2019 ]
    is defined as the time from the first dose of treatment dose and death from any cause
  • Adverse Events [ Time Frame: October 2015 - December 2019 ]
    complications of lorlatinib therapy will be recorded
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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
  • Non-small Cell Lung Cancer Metastatic
  • ALK Gene Rearrangement Positive
  • ROS-1 Gene Rearrangement Positive
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
 (submitted: October 19, 2020)
291
Original Estimated Enrollment
 (submitted: October 30, 2018)
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:

  • 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
Sex/Gender
Sexes Eligible for Study: All
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
Plan to Share IPD: No
Responsible Party Intergroupe Francophone de Cancerologie Thoracique
Study Sponsor Intergroupe Francophone de Cancerologie Thoracique
Collaborators Pfizer
Investigators
Principal Investigator: Nicolas Girard, MD, PhD Institut Curie Paris
PRS Account Intergroupe Francophone de Cancerologie Thoracique
Verification Date February 2020