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ALK Inhibitor
Lorlatinib for Non-Small Cell Lung Cancer
Phase 4
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 6 weeks up to approximately 4 years
Awards & highlights
Study Summary
This trial is testing whether lorlatinib is safe and effective for people with lung cancer that has progressed after treatment with alectinib or ceritinib.
Who is the study for?
This trial is for people with ALK-positive non-small cell lung cancer that worsened after treatment with alectinib or ceritinib. Participants should have manageable side effects from previous treatments, at least one measurable lung lesion, and be in good physical condition (ECOG 0-1). They must not be pregnant or breastfeeding and agree to use contraception. People can't join if they've had certain heart conditions, other recent cancers, severe allergies to the drug's components, or are unable to take oral medication.Check my eligibility
What is being tested?
The study tests Lorlatinib's safety and effectiveness in treating ALK-positive non-small cell lung cancer over up to four years. Patients will take Lorlatinib daily by mouth and visit the study site every six weeks for monitoring. The trial includes those who saw their cancer progress after initial treatment with either alectinib or ceritinib.See study design
What are the potential side effects?
Possible side effects of Lorlatinib may include high cholesterol levels, mood changes including anxiety and depression, cognitive effects like confusion or memory problems, nerve damage causing tingling sensations or pain in hands/feet (neuropathy), weight gain due to fluid retention (edema), shortness of breath (dyspnea), fatigue, diarrhea among others.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer is stage IV with an ALK rearrangement.
Select...
I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 6 weeks up to approximately 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 6 weeks up to approximately 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Patients With Overall Objective Response (OR) based on independent central review (ICR)
Secondary outcome measures
Adverse Event (AE) as graded by NCI CTCAE (v 4.03)
Duration of Intra-Cranial Response (IC-DoR) based on ICR/ derived INV
Duration of Response (DoR) based on ICR/ derived investigator
+6 moreSide effects data
From 2020 Phase 1 trial • 29 Patients • NCT0354230513%
Dizziness
13%
Headache
13%
Skin laceration
13%
Oropharyngeal pain
13%
Upper respiratory tract infection
13%
Diarrhoea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Normal Function
Mild Impairment
Moderate Impairment
Severe Impairment
Trial Design
1Treatment groups
Experimental Treatment
Group I: LorlatinibExperimental Treatment1 Intervention
Participants will take 100 mg (four, 25 mg tablets) once daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lorlatinib
2018
Completed Phase 4
~440
Find a Location
Who is running the clinical trial?
PfizerLead Sponsor
4,575 Previous Clinical Trials
10,923,030 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,482 Previous Clinical Trials
8,099,292 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had any cancer other than my current NSCLC or certain low-risk types in the last 3 years.I haven't had radiation therapy (except for bone pain relief) in the last 2 weeks.I am fully active or can carry out light work.My lung cancer is stage IV with an ALK rearrangement.I have a measurable tumor outside the brain and may have stable brain metastases.I have had radiation to more than a quarter of my bone marrow.My cancer progressed after first-line treatment with alectinib or ceritinib.Any side effects from my previous treatments are mild or gone.I do not have any serious infections like HBV, HCV, HIV, or AIDS.My heart's pumping ability is below normal according to tests.I haven't had serious heart or blood vessel problems in the last 3 months.I have previously been treated with ALK inhibitors other than alectinib or ceritinib.I have not had major surgery in the last 4 weeks.You have traits that could make you more likely to get acute pancreatitis, as determined by the researchers.I have a history of lung scarring or inflammation.I haven't taken specific strong medications or certain foods that affect drug metabolism in the last 12 days.I have spinal cord compression but have stable pain and neurological function for the last 4 weeks.I am not pregnant or breastfeeding and agree to use contraception during and after the study.I am a male and agree to use contraception during and for 98 days after the study.I do not have major stomach or bowel problems that affect how I eat or absorb food.My bone marrow, pancreas, kidneys, and liver are all working well.I stopped taking alectinib or ceritinib long enough before starting lorlatinib.
Research Study Groups:
This trial has the following groups:- Group 1: Lorlatinib
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent has Lorlatinib been tested in clinical research?
"Lorlatinib was initially evaluated in 2016 at Ziekehuisgroep Twente. Since that time, 12 trials have been concluded and 16 active studies are underway; a great many of them occurring within Athens, Georgia."
Answered by AI
Does Lorlatinib carry any risks for those using it therapeutically?
"With a score of 3, Lorlatinib has been deemed relatively safe due to its elevated Phase 4 status which implies that the drug is approved for public use."
Answered by AI
Does this research endeavor represent a pioneering effort?
"Currently, 16 clinical studies related to Lorlatinib are recruiting patients across 432 cities and 26 nations. Janssen LP initiated the first trial in 2016; this Phase 2 study involved 1550 volunteers and was concluded with drug approval. Subsequently, an additional 12 trials have been conducted since then."
Answered by AI
How many participants is the research team recruiting for this clinical trial?
"Affirmative. Clinicaltrials.gov data verifies that this scientific inquiry, which was first published on October 8th 2020, is currently looking for subjects to enrol. 85 patients are required from 2 distinct trial sites."
Answered by AI
Does this trial still offer the opportunity for patients to enroll?
"According to clinicaltrials.gov, recruitment is currently ongoing for this trial which was first made available on October 8th 2020 and the most recent update occurred on November 17th 2022."
Answered by AI
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