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

NCT03052608

Last updated date
Study Location
Bendigo Day Surgery Collection Centre and Laboratory
Bendigo, Victoria, 3550, Australia
Contact
1-800-718-1021

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

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[email protected]

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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.

NEED INFO?

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

Pfizer Clinical Trials Contact Center

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[email protected]

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC
Official Title  ICMJE 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
Brief 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 naïve and to compare lorlatinib to crizotinib with respect to overall survival in the same population
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Non-Small-Cell Lung
Intervention  ICMJE
  • Drug: Lorlatinib
    ALK-positive NSCL treatment
    Other Name: PF-06463922
  • Drug: Crizotinib
    ALK-positive NSCL treatment
    Other Name: Xalkori
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 9, 2017)
280
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 1, 2024
Actual Primary Completion Date March 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Canada,   China,   Czechia,   France,   Germany,   Hong Kong,   India,   Italy,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   Poland,   Russian Federation,   Singapore,   Spain,   Taiwan,   Turkey,   United Kingdom,   United States
Removed Location Countries Denmark
 
Administrative Information
NCT Number  ICMJE NCT03052608
Other Study ID Numbers  ICMJE B7461006
2016-003315-35 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP