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

Last updated on March 18, 2019

FOR MORE INFORMATION
Study Location
NeoGenomics Laboratory (Attn: BioPharm Services, Project support Administrator)
Aliso Viejo, California, 92656 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-Small-Cell Lung Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

1. known strong CYP3A inhibitors .

2. known strong CYP3A inducers

3. 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.

NCT03052608
Pfizer
Recruiting
A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now