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

Last updated on June 16, 2018

FOR MORE INFORMATION
Study Location
Florida Cancer Specialists
Altamonte Springs, Florida, 32701 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

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A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC
A Phase 3, Randomized, Open-label Study Of Lorlatinib (Pf-06463922) Monotherapy Versus Crizotinib Monotherapy In The First-line Treatment Of Patients With Advanced Alk-positive Non-small Cell Lung Cancer
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
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Carcinoma, Non-Small-Cell Lung
  • Drug: Lorlatinib
    ALK-positive NSCL treatment
    Other Name: PF-06463922
  • Drug: Crizotinib
    ALK-positive NSCL treatment
    Other Name: Xalkori
  • Experimental: Lorlatinib
    Lorlatinib single agent, 100 mg (4 x 25 mg) oral tables, QD, continuously
    Intervention: Drug: Lorlatinib
  • Active Comparator: Crizotinib
    Crizotinib single agent, 250 mg (1 x 250) oral capsules, BID, continuously
    Intervention: Drug: Crizotinib
Gainor JF, Shaw AT. J-ALEX: alectinib versus crizotinib in ALK-positive lung cancer. Lancet. 2017 Jul 1;390(10089):3-4. doi: 10.1016/S0140-6736(17)31074-7. Epub 2017 May 10.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
280
October 23, 2023
February 17, 2020   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Australia,   Belgium,   Canada,   Denmark,   France,   Germany,   Italy,   Japan,   Korea, Republic of,   Netherlands,   Poland,   Russian Federation,   Singapore,   Spain,   Taiwan,   United Kingdom,   United States
 
 
NCT03052608
B7461006
2016-003315-35 ( EudraCT Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
URL: http://
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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