Lorlatinib in ALK Inhibitor Treated Unresectable Advanced/Recurrent ALK-Positive Non Small Cell Lung Cancer Patients in India

NCT04541706

Last updated date
Study Location
The Gujarat Cancer and Research Institute
Ahmedabad, Gujarat, 380016, India
Contact
1-800-718-1021

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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.
Advanced Non-Small Cell Lung Cancer
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

1. Evidence of histologically or cytologically confirmed diagnosis of unresectable advanced and/or recurrent NSCLC that carries an ALK rearrangement, as detected by an appropriate test.

2. Disease progression or intolerance to 1 previous treatment with ALK TKI. Participants may have also had prior chemotherapy for their advanced and/or recurrent disease.

3. Participants with asymptomatic CNS metastases (including participants controlled with stable or decreasing steroid use within the last 2 weeks prior to study enrollment) will be eligible.

4. Age ≥18 years.

5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2.

6. Adequate hematologic and renal function as defined as:

1. Absolute neutrophil count (ANC) ≥1,000/mm3;

2. Platelets ≥50,000/mm3;

3. Hemoglobin ≥8 g/dL;

4. Estimated creatinine clearance ≥30 mL/min as calculated using the method standard for the institution.

7. Adequate liver function, including:

1. Total serum bilirubin ≤1.5 × upper limit of normal (ULN);

2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN (≤5.0 × ULN in case of liver metastases).

8. Adequate pancreatic function, including:

1. Serum total amylase ≤1.5 × ULN.*

2. Serum lipase <1.5 × ULN. *if total amylase >1.5 × ULN, but pancreatic amylase is within the ULN, the participant may be enrolled.

9. Acute effects of any prior therapy resolved to baseline severity or to CTCAE Grade <1 except for AEs that in the Investigator's judgment do not constitute a safety risk for the participant.

10. Systemic anticancer therapy completed within a minimum of 5 half-lives of study enrollment (unless clinically meaningful tumor flare per discretion of the Investigator, in which discussion with the Sponsor is warranted).

11. Evidence of a personally signed and dated informed consent document indicating that the participant (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

12. Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.

13. Pregnancy test for females of childbearing potential negative at Screening or female participants who are not of childbearing potential. Male and female participants of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception from the time of Screening, throughout the study and for 3 months after the last dose of assigned treatment, 6 months if female participants.

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


1. Radiation therapy (except palliative to relieve bone pain) within 2 weeks of study
enrollment. Palliative radiation (<10 fractions) must have been completed at least 48
hours prior to study enrollment. Stereotactic or small field brain irradiation must
have completed at least 2 weeks prior to study enrollment. Whole brain radiation must
have completed at least 4 weeks prior to study enrollment. Prior irradiation to >25%
of the bone marrow.


2. Major surgery within 4 weeks prior to enrollment. Minor surgical procedures (eg, port
insertion) are not excluded, but sufficient time should have passed for adequate wound
healing.


3. Known prior or suspected severe hypersensitivity to study drug or any component in its
formulation.


4. Active and clinically significant bacterial, fungal, or viral infection.


5. Clinically significant vascular (both arterial and venous) and non-vascular cardiac
conditions (active or within 3 months prior to enrollment), which may include, but are
not limited to:


1. Arterial disease such as cerebral vascular accident/stroke (including transient
ischemic attack [TIA]), myocardial infarction, unstable angina;


2. Venous diseases such as cerebral venous thrombosis, symptomatic pulmonary
embolism;


3. Non-vascular cardiac disease such as congestive heart failure (New York Heart
Association Classification Class ≥II), second degree or third degree
atrioventricular (AV) block (unless paced) or any AV block with PR interval >220
msec; or ongoing cardiac dysrhythmias of NCI CTCAE Grade ≥2, uncontrolled atrial
fibrillation of any grade, bradycardia defined as <50 beats per minute (bpm)
(unless participant is otherwise healthy such as long distance runners, etc.),
machine read ECG with QT interval corrected for heart rate (QTc) >470 msec, or
congenital long QT syndrome.


6. History or known presence of interstitial fibrosis, interstitial lung disease (ILD),
pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, obliterative
bronchiolitis, and pulmonary fibrosis.


7. 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 enrollment in this study.


8. 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 enrollment.


9. Concurrent use of any of the following food or drugs (consult the Sponsor if in doubt
whether a food or a drug falls into any of the categories described below) within 12
days prior to the first dose of lorlatinib:


1. Known strong cytochrome (CYP)3A inducers (eg, carbamazepine, enzalutamide,
mitotane, rifampin, St. John's Wort).


2. Known strong CYP3A inhibitors (eg, grapefruit juice or grapefruit/grapefruit
related citrus fruits [eg, Seville oranges, pomelos], boceprevir, cobicistat,
clarithromycin, conivaptan, diltiazem, idelalisib, indinavir, itraconazole,
ketoconazole, lopinavir, nelfinavir, paritaprevir, posaconazole, ritonavir alone
and with elvitegravir or indinavir or lopinavir or paritaprevir or ombitasvir or
dasabuvir or saquinavir or tipranavir, telaprevir and voriconazole). The topical
use of these medications (if applicable), such as 2% ketoconazole cream, is
allowed.


3. Known CYP3A substrates with narrow therapeutic index, such as pimozide,
quinidine, tacrolimus, cyclosporine, sirolimus, alfentanil, fentanyl (including
transdermal patch) or ergot alkaloids (ergotamine, dihydroergotamine).


4. Known permeability glycoprotein (P-gp) substrates with a narrow therapeutic index
(eg, digoxin).


10. Participants who are investigational site staff members directly involved in the
conduct of the study and their family members, site staff members otherwise supervised
by the Investigator, or participants who are Pfizer employees directly involved in the
conduct of the study.


11. Participation in other studies involving investigational drug(s) (Phases 1-4) during
study participation.


12. Breastfeeding female participants.

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Advanced Non-Small Cell Lung CancerLorlatinib in ALK Inhibitor Treated Unresectable Advanced/Recurrent ALK-Positive Non Small Cell Lung Cancer Patients in India
NCT04541706
  1. Ahmedabad, Gujarat
  2. Ahmedabad, Gujarat
  3. Nagpur, Maharashtra
  4. Pune, Maharashtra
  5. New Delhi, Delhi
  6. Gurugram, Haryana
  7. Nashik, Maharashtra
  8. Pune, Maharashtra
  9. Pune, Maharashtra
  10. Thane, Maharashtra
  11. Hyderabad, Telangana State
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Lorlatinib in ALK Inhibitor Treated Unresectable Advanced/Recurrent ALK-Positive Non Small Cell Lung Cancer Patients in India
Official Title  ICMJE SINGLE-ARM STUDY TO EVALUATE THE SAFETY OF LORLATINIB IN ALK INHIBITOR-TREATED UNRESECTABLE ADVANCED AND/OR RECURRENT ALK-POSITIVE NON-SMALL CELL LUNG CANCER PARTICIPANTS IN INDIA
Brief Summary

Lorlatinib is a third-generation, oral, reversible, ATP-competitive, macrocyclic TKI of ALK and ROS1. Lorlatinib was specifically designed to penetrate the CNS and to overcome known secondary resistance mutations in the ALK tyrosine kinase domain.

This is a Phase 4, open-label, multicenter, non-randomized, prospective, single arm study to evaluate the safety and tolerability of lorlatinib in adult participants with unresectable advanced and/or recurrent ALK-positive NSCLC with resistance or intolerance to at least 1 prior ALK inhibitor treatment.

This study is being conducted as a post approval study to fulfill Central Drugs Standard Control Organization (CDSCO) request relating to additional information on use of Lorlatinib in Indian patients.

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 Advanced Non-Small Cell Lung Cancer
Intervention  ICMJE Drug: Lorlatinib
Lorlatinib will be supplied for oral administration as 25 mg tablets. The recommended dosage of lorlatinib is 100 mg orally once daily.
Other Name: LORBRIQUA
Study Arms  ICMJE Experimental: Lorlatinib
The recommended dosage of lorlatinib is 100 mg orally once daily, with or without food, until disease progression, unacceptable toxicity, or participant refusal/lost to follow-up. About 100 participants will be enrolled in this study.
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 4, 2020)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 20, 2023
Estimated Primary Completion Date December 20, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Evidence of histologically or cytologically confirmed diagnosis of unresectable advanced and/or recurrent NSCLC that carries an ALK rearrangement, as detected by an appropriate test.
  2. Disease progression or intolerance to 1 previous treatment with ALK TKI. Participants may have also had prior chemotherapy for their advanced and/or recurrent disease.
  3. Participants with asymptomatic CNS metastases (including participants controlled with stable or decreasing steroid use within the last 2 weeks prior to study enrollment) will be eligible.
  4. Age ?18 years.
  5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2.
  6. Adequate hematologic and renal function as defined as:

    1. Absolute neutrophil count (ANC) ?1,000/mm3;
    2. Platelets ?50,000/mm3;
    3. Hemoglobin ?8 g/dL;
    4. Estimated creatinine clearance ?30 mL/min as calculated using the method standard for the institution.
  7. Adequate liver function, including:

    1. Total serum bilirubin ?1.5 × upper limit of normal (ULN);
    2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ?2.5 × ULN (?5.0 × ULN in case of liver metastases).
  8. Adequate pancreatic function, including:

    1. Serum total amylase ?1.5 × ULN.*
    2. Serum lipase <1.5 × ULN. *if total amylase >1.5 × ULN, but pancreatic amylase is within the ULN, the participant may be enrolled.
  9. Acute effects of any prior therapy resolved to baseline severity or to CTCAE Grade <1 except for AEs that in the Investigator's judgment do not constitute a safety risk for the participant.
  10. Systemic anticancer therapy completed within a minimum of 5 half-lives of study enrollment (unless clinically meaningful tumor flare per discretion of the Investigator, in which discussion with the Sponsor is warranted).
  11. Evidence of a personally signed and dated informed consent document indicating that the participant (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
  12. Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.
  13. Pregnancy test for females of childbearing potential negative at Screening or female participants who are not of childbearing potential. Male and female participants of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception from the time of Screening, throughout the study and for 3 months after the last dose of assigned treatment, 6 months if female participants.

Exclusion Criteria:

  1. Radiation therapy (except palliative to relieve bone pain) within 2 weeks of study enrollment. Palliative radiation (<10 fractions) must have been completed at least 48 hours prior to study enrollment. Stereotactic or small field brain irradiation must have completed at least 2 weeks prior to study enrollment. Whole brain radiation must have completed at least 4 weeks prior to study enrollment. Prior irradiation to >25% of the bone marrow.
  2. Major surgery within 4 weeks prior to enrollment. Minor surgical procedures (eg, port insertion) are not excluded, but sufficient time should have passed for adequate wound healing.
  3. Known prior or suspected severe hypersensitivity to study drug or any component in its formulation.
  4. Active and clinically significant bacterial, fungal, or viral infection.
  5. Clinically significant vascular (both arterial and venous) and non-vascular cardiac conditions (active or within 3 months prior to enrollment), which may include, but are not limited to:

    1. Arterial disease such as cerebral vascular accident/stroke (including transient ischemic attack [TIA]), myocardial infarction, unstable angina;
    2. Venous diseases such as cerebral venous thrombosis, symptomatic pulmonary embolism;
    3. Non-vascular cardiac disease such as congestive heart failure (New York Heart Association Classification Class ?II), second degree or third degree atrioventricular (AV) block (unless paced) or any AV block with PR interval >220 msec; or ongoing cardiac dysrhythmias of NCI CTCAE Grade ?2, uncontrolled atrial fibrillation of any grade, bradycardia defined as <50 beats per minute (bpm) (unless participant is otherwise healthy such as long distance runners, etc.), machine read ECG with QT interval corrected for heart rate (QTc) >470 msec, or congenital long QT syndrome.
  6. History or known presence of interstitial fibrosis, interstitial lung disease (ILD), pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, obliterative bronchiolitis, and pulmonary fibrosis.
  7. 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 enrollment in this study.
  8. 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 enrollment.
  9. Concurrent use of any of the following food or drugs (consult the Sponsor if in doubt whether a food or a drug falls into any of the categories described below) within 12 days prior to the first dose of lorlatinib:

    1. Known strong cytochrome (CYP)3A inducers (eg, carbamazepine, enzalutamide, mitotane, rifampin, St. John's Wort).
    2. Known strong CYP3A inhibitors (eg, grapefruit juice or grapefruit/grapefruit related citrus fruits [eg, Seville oranges, pomelos], boceprevir, cobicistat, clarithromycin, conivaptan, diltiazem, idelalisib, indinavir, itraconazole, ketoconazole, lopinavir, nelfinavir, paritaprevir, posaconazole, ritonavir alone and with elvitegravir or indinavir or lopinavir or paritaprevir or ombitasvir or dasabuvir or saquinavir or tipranavir, telaprevir and voriconazole). The topical use of these medications (if applicable), such as 2% ketoconazole cream, is allowed.
    3. Known CYP3A substrates with narrow therapeutic index, such as pimozide, quinidine, tacrolimus, cyclosporine, sirolimus, alfentanil, fentanyl (including transdermal patch) or ergot alkaloids (ergotamine, dihydroergotamine).
    4. Known permeability glycoprotein (P-gp) substrates with a narrow therapeutic index (eg, digoxin).
  10. Participants who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the Investigator, or participants who are Pfizer employees directly involved in the conduct of the study.
  11. Participation in other studies involving investigational drug(s) (Phases 1-4) during study participation.
  12. Breastfeeding female participants.
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 India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04541706
Other Study ID Numbers  ICMJE B7461030
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
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 October 2020

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