Home
Clinical Trials
NCT03052608

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

Last Updated: 2024-12-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

296 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-27

Study Completion Date

2028-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 naïve and to compare lorlatinib to crizotinib with respect to overall survival in the same population

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Carcinoma, Non-Small-Cell Lung

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

ALK; anaplastic lymphoma kinase; Non-Small-Cell Lung cancer; NSCLC

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lorlatinib

Lorlatinib single agent, 100 mg (4 x 25 mg) oral tables, QD, continuously

Group Type EXPERIMENTAL

Lorlatinib

Intervention Type DRUG

ALK-positive NSCL treatment

Crizotinib

Crizotinib single agent, 250 mg (1 x 250) oral capsules, BID, continuously

Group Type ACTIVE_COMPARATOR

Crizotinib

Intervention Type DRUG

ALK-positive NSCL treatment

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lorlatinib

ALK-positive NSCL treatment

Intervention Type DRUG

Crizotinib

ALK-positive NSCL treatment

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

PF-06463922 Xalkori

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Florida Cancer Specialists

Altamonte Springs, Florida, United States

Site Status

Florida Cancer Specialists

Brandon, Florida, United States

Site Status

Florida Cancer Specialists

Clearwater, Florida, United States

Site Status

Florida Cancer Specialists

Gainesville, Florida, United States

Site Status

Florida Cancer Specialists

Largo, Florida, United States

Site Status

Florida Cancer Specialists

Lecanto, Florida, United States

Site Status

Florida Cancer Specialists

Orange City, Florida, United States

Site Status

Florida Cancer Specialists

Orlando, Florida, United States

Site Status

Florida Cancer Specialists

Spring Hill, Florida, United States

Site Status

Florida Cancer Specialists

St. Petersburg, Florida, United States

Site Status

Florida Cancer Specialists

Tampa, Florida, United States

Site Status

Florida Cancer Specialists

Tavares, Florida, United States

Site Status

Florida Cancer Specialists

The Villages, Florida, United States

Site Status

Florida Cancer Specialists

Winter Park, Florida, United States

Site Status

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Ophthalmic Consultants of Boston Inc

Boston, Massachusetts, United States

Site Status

The William P. Beetham Eye Institute, Joslin Diabetes Center

Boston, Massachusetts, United States

Site Status

University of Rochester Cancer Center Pharmacy

Rochester, New York, United States

Site Status

University of Rochester Medical Center

Rochester, New York, United States

Site Status

Tennessee Oncology, PLLC

Dickson, Tennessee, United States

Site Status

Tennessee Oncology, PLLC

Franklin, Tennessee, United States

Site Status

Tennessee Oncology, PLLC

Gallatin, Tennessee, United States

Site Status

Tennessee Oncology, PLLC

Hermitage, Tennessee, United States

Site Status

Tennessee Oncology, PLLC

Lebanon, Tennessee, United States

Site Status