A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC

  • STATUS
    Recruiting
  • End date
    Feb 1, 2024
  • participants needed
    280
  • sponsor
    Pfizer
Updated on 28 January 2021
metastasis
crizotinib

Summary

A phase 3 study to demonstrate whether lorlatinib given as monotherapy is superior to crizotinib alone in prolonging the progression-free survival in advanced ALK-positive NSCLC patients who are treatment nave and to compare lorlatinib to crizotinib with respect to overall survival in the same population

Details
Condition Non-Small Cell Lung Cancer
Treatment Crizotinib, Lorlatinib
Clinical Study IdentifierNCT03052608
SponsorPfizer
Last Modified on28 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Non-Small Cell Lung Cancer?
Do you have any of these conditions: Do you have Non-Small Cell Lung Cancer??
Do you have any of these conditions: Do you have Non-Small Cell Lung Cancer??
Do you have any of these conditions: Do you have Non-Small Cell Lung Cancer??
Do you have any of these conditions: Do you have Non-Small Cell Lung Cancer??
Do you have any of these conditions: Do you have Non-Small Cell Lung Cancer??
Histologically or cytologically confirmed diagnosis of locally advanced or metastatic ALK-positive NSCLC; at least 1 extracranial measurable target lesion not previously irradiated. CNS metastases allowed if asymptomatic and not currently requiring corticosteroid treatment
Availability of an archival FFPE tissue specimen
No prior systemic NSCLC treatment
ECOG PS 0, 1, or 2
Age 18 years
Adequate Bone Marrow, Liver, Renal, Pancreatic Function
Negative pregnancy test for females of childbearing potential

Exclusion Criteria

Spinal cord compression unless good pain control attained
Major surgery within 4 weeks prior to randomization
Radiation therapy within 2 weeks prior to randomization, including stereotactic or partial brain irradiation. Whole brain irradiation within 4 weeks prior to randomization
Active bacterial, fungal, or viral infection
Clinically significant cardiovascular disease, active or within 3 months prior to enrollment. Ongoing cardiac dysrhythmias, uncontrolled atrial fibrillation, bradycardia or congenital long QT syndrome
Predisposing characteristics for acute pancreatitis in the last month prior to randomization
History of extensive, disseminated, bilateral or presence of Grade 3 or 4 interstitial fibrosis or interstitial lung disease
Active malignancy (other than NSCLC, non melanoma skin cancer, in situ cervical cancer, papillary thyroid cancer, LCIS/DCIS of the breast, or localized prostate cancer) within the last 3 years prior to randomization
Concurrent use of any of the following food or drugs within 12 days prior to the first dose of lorlatinib or crizotinib
known strong CYP3A inhibitors
known strong CYP3A inducers
known P gp substrates with a narrow therapeutic index
Concurrent use of CYP3A substrates with narrow therapeutic indices within 12 days prior to the first dose of lorlatinib or crizotinib
Other severe acute or chronic medical or psychiatric condition, including recent or active suicidal ideation or behavior, or laboratory abnormality that may increase the risk associated with study participation or interfere with the interpretation of study results
Investigational site staff members directly involved in the conduct of the study and their family members, or Pfizer employees, including their family members, directly involved in the conduct of the study
Participation in other studies involving investigational drug(s) within 2 weeks prior to study entry and/or during study participation
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