Study of Lorlatinib In Participants With Anaplastic Lymphoma Kinase (ALK) -Positive NSCLC

NCT04362072

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Carcinoma, Non-Small-Cell Lung
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

- Participants must have evidence of histologically or cytologically confirmed diagnosis of metastatic NSCLC (Stage IV, American Joint Committee on Cancer [AJCC] v7.0) that carries an ALK rearrangement, as determined by the Food and Drug Administration (FDA) approved fluorescence in situ hybridization (FISH) assay (Abbott Molecular Inc) or by Immunohistochemistry (IHC) (Ventana Inc).

- Disease Status Requirements: disease progression after alectinib or ceritinib as first line therapy (the study will limit enrollment of participants with best response of progression or indeterminate on prior alectinib to 8 participants). Participants may have had prior chemotherapy, but only if before starting treatment with alectinib or ceritinib.

- Tumor Requirements: All Participants must have at least one measurable target extracranial lesion according to RECIST v1.1. Participants with asymptomatic CNS metastases (including participants controlled with stable or decreasing steroid use within the last 2 weeks prior to study entry) will be eligible. Participants who have leptomeningeal disease (LM) or carcinomatous meningitis (CM) will be eligible if the LM/CM is visualized on magnetic resonance imaging (MRI) or if documented baseline cerebral spinal fluid (CSF) positive cytology is available.

- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.

- Adequate bone marrow functioning, pancreatic function, renal function and liver function

- Acute effects of any prior therapy resolved to baseline severity or to CTCAE Grade ≤1 except for adverse events (AEs) that in the investigator' judgment do not constitute a safety risk for the participant.

- Systemic anti-cancer therapy with alectinib or ceritinib discontinued within a minimum of 5 half-lives prior to first dose of lorlatinib on the study (unless clinically meaningful tumor flare per discretion of the investigator, in which discussion with the sponsor is warranted).

- Male participants are eligible to participate if they agree to use proper contraception during the intervention period and for at least 98 days after the last dose of study intervention

- Female participants are eligible to participate if they are not pregnant or breastfeeding, and agree to use proper contraception during the intervention period and for at least 35 days after the last dose of study intervention.

- Capable of giving signed informed consent and willingness and ability to comply with the study scheduled visits and other procedures.

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


- Prior ALK TKI treatment or anti-cancer treatment other than first line alectinib or
ceritinib.


- Spinal cord compression unless the participant has good pain control attained through
therapy, and there is stabilization or recovery of neurological function for the 4
weeks prior to randomization.


- Gastrointestinal abnormalities, including inability to take oral medication;
requirement for intravenous alimentation; prior surgical procedures affecting
absorption including total gastric resection or lap band; active inflammatory
gastrointestinal disease, chronic diarrhea, symptomatic diverticular disease;
treatment for active peptic ulcer disease in the past 6 months; malabsorption
syndromes.


- Active and clinically significant bacterial, fungal, or viral infection including
hepatitis B virus (HBV) or hepatitis C virus (HCV), known human immunodeficiency virus
(HIV), or acquired immunodeficiency syndrome (AIDS) related illness.


- Clinically significant vascular (both arterial and venous) and non-vascular cardiac
conditions, (active or within 3 months prior to enrollment)


- Participants presenting with abnormal Left Ventricular Ejection Fraction (LVEF) by
echocardiogram or Multi-Gated Acquisition Scan according to institutional lower
limits.


- Participants with predisposing characteristics for acute pancreatitis according to
investigator judgment


- History or known presence of interstitial fibrosis, interstitial lung disease,
pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, obliterative
bronchiolitis, and pulmonary fibrosis.


- Other severe acute or chronic medical or psychiatric condition, including recent
(within the past year) or active suicidal ideation or behavior, or laboratory
abnormality that may increase the risk associated with study participation or
investigational product administration or may interfere with the interpretation of
study results and, in the judgment of the investigator, would make the participant
inappropriate for entry into this study.


- Evidence of active malignancy (other than current NSCLC, non-melanoma skin cancer, in
situ cervical cancer, papillary thyroid cancer, ductal carcinoma in situ (DCIS) of the
breast or localized and presumed cured prostate cancer) within the last 3 years prior
to randomization.


- Radiation therapy (except palliative to relieve bone pain) within 2 weeks of study
entry. Palliative radiation must have been completed at least 48 hours prior to study
entry. Stereotactic or small field brain irradiation must have completed at least 2
weeks prior to study entry. Whole brain radiation must have completed at least 4 weeks
prior to study entry.


- Prior irradiation to >25% of the bone marrow.


- Concurrent use of any of the following food or drugs within 12 days prior to the first
dose of lorlatinib: known strong CYP3A inducers, known strong CYP3A inhibitors, known
CYP3A substrates with narrow therapeutic index, known permeability glycoprotein (P-gp)
substrates with a narrow therapeutic index


- Major surgery within 4 weeks prior to enrollment.


- Known prior or suspected severe hypersensitivity to study interventions or any
component in their formulations.


- Investigator site staff members directly involved in the conduct of the study and
their family members, site staff members otherwise supervised by the investigator, or
Pfizer employees, including their family members, directly involved in the conduct of
the study.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study of Lorlatinib In Participants With Anaplastic Lymphoma Kinase (ALK) -Positive NSCLC
Official Title  ICMJE Single-Arm Study of Lorlatinib in Participants With Anaplastic Lymphoma Kinase (ALK)-Positive Non-Small Cell Lung Cancer (NSCLC) Whose Disease Progressed After One Prior Second-Generation ALK Tyrosine Kinase Inhibitor (TKI)
Brief Summary A Phase 4 study to assess Overall and Intracranial Response Rate of single-agent lorlatinib in participants with advanced ALK-positive NSCLC whose disease has progressed on alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI)therapy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Carcinoma
  • Non-Small-Cell Lung
Intervention  ICMJE Drug: Lorlatinib
25 milligram (mg) tablet
Study Arms  ICMJE Experimental: Lorlatinib
Participants will take 100 mg (four, 25 mg tablets) once daily.
Intervention: Drug: Lorlatinib
Publications * Not Provided

*   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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 22, 2020)
85
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 17, 2023
Estimated Primary Completion Date October 17, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participants must have evidence of histologically or cytologically confirmed diagnosis of metastatic NSCLC (Stage IV, American Joint Committee on Cancer [AJCC] v7.0) that carries an ALK rearrangement, as determined by the Food and Drug Administration (FDA) approved fluorescence in situ hybridization (FISH) assay (Abbott Molecular Inc) or by Immunohistochemistry (IHC) (Ventana Inc).
  • Disease Status Requirements: disease progression after alectinib or ceritinib as first line therapy (the study will limit enrollment of participants with best response of progression or indeterminate on prior alectinib to 8 participants). Participants may have had prior chemotherapy, but only if before starting treatment with alectinib or ceritinib.
  • Tumor Requirements: All Participants must have at least one measurable target extracranial lesion according to RECIST v1.1. Participants with asymptomatic CNS metastases (including participants controlled with stable or decreasing steroid use within the last 2 weeks prior to study entry) will be eligible. Participants who have leptomeningeal disease (LM) or carcinomatous meningitis (CM) will be eligible if the LM/CM is visualized on magnetic resonance imaging (MRI) or if documented baseline cerebral spinal fluid (CSF) positive cytology is available.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
  • Adequate bone marrow functioning, pancreatic function, renal function and liver function
  • Acute effects of any prior therapy resolved to baseline severity or to CTCAE Grade ?1 except for adverse events (AEs) that in the investigator' judgment do not constitute a safety risk for the participant.
  • Systemic anti-cancer therapy with alectinib or ceritinib discontinued within a minimum of 5 half-lives prior to first dose of lorlatinib on the study (unless clinically meaningful tumor flare per discretion of the investigator, in which discussion with the sponsor is warranted).
  • Male participants are eligible to participate if they agree to use proper contraception during the intervention period and for at least 98 days after the last dose of study intervention
  • Female participants are eligible to participate if they are not pregnant or breastfeeding, and agree to use proper contraception during the intervention period and for at least 35 days after the last dose of study intervention.
  • Capable of giving signed informed consent and willingness and ability to comply with the study scheduled visits and other procedures.

Exclusion criteria:

  • Prior ALK TKI treatment or anti-cancer treatment other than first line alectinib or ceritinib.
  • Spinal cord compression unless the participant has good pain control attained through therapy, and there is stabilization or recovery of neurological function for the 4 weeks prior to randomization.
  • Gastrointestinal abnormalities, including inability to take oral medication; requirement for intravenous alimentation; prior surgical procedures affecting absorption including total gastric resection or lap band; active inflammatory gastrointestinal disease, chronic diarrhea, symptomatic diverticular disease; treatment for active peptic ulcer disease in the past 6 months; malabsorption syndromes.
  • Active and clinically significant bacterial, fungal, or viral infection including hepatitis B virus (HBV) or hepatitis C virus (HCV), known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS) related illness.
  • Clinically significant vascular (both arterial and venous) and non-vascular cardiac conditions, (active or within 3 months prior to enrollment)
  • Participants presenting with abnormal Left Ventricular Ejection Fraction (LVEF) by echocardiogram or Multi-Gated Acquisition Scan according to institutional lower limits.
  • Participants with predisposing characteristics for acute pancreatitis according to investigator judgment
  • History or known presence of interstitial fibrosis, interstitial lung disease, pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, obliterative bronchiolitis, and pulmonary fibrosis.
  • Other severe acute or chronic medical or psychiatric condition, including recent (within the past year) or active suicidal ideation or behavior, or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
  • Evidence of active malignancy (other than current NSCLC, non-melanoma skin cancer, in situ cervical cancer, papillary thyroid cancer, ductal carcinoma in situ (DCIS) of the breast or localized and presumed cured prostate cancer) within the last 3 years prior to randomization.
  • Radiation therapy (except palliative to relieve bone pain) within 2 weeks of study entry. Palliative radiation must have been completed at least 48 hours prior to study entry. Stereotactic or small field brain irradiation must have completed at least 2 weeks prior to study entry. Whole brain radiation must have completed at least 4 weeks prior to study entry.
  • Prior irradiation to >25% of the bone marrow.
  • Concurrent use of any of the following food or drugs within 12 days prior to the first dose of lorlatinib: known strong CYP3A inducers, known strong CYP3A inhibitors, known CYP3A substrates with narrow therapeutic index, known permeability glycoprotein (P-gp) substrates with a narrow therapeutic index
  • Major surgery within 4 weeks prior to enrollment.
  • Known prior or suspected severe hypersensitivity to study interventions or any component in their formulations.
  • Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or Pfizer employees, including their family members, directly involved in the conduct of the study.
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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04362072
Other Study ID Numbers  ICMJE B7461027
2019-002504-41 ( EudraCT Number )
Has Data Monitoring Committee No
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 April 2020

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