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ALK Inhibitor
Lorlatinib vs Crizotinib for Non-Small Cell Lung Cancer
Phase 3
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No prior systemic NSCLC treatment.
Age ≥18 years.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from time of study start up to 45 months
Awards & highlights
Study Summary
This trial is testing whether a new drug, lorlatinib, is better than the standard drug, crizotinib, at treating patients with a certain type of lung cancer who have not yet received treatment.
Who is the study for?
This trial is for adults over 18 with advanced ALK-positive NSCLC who haven't had treatment before. They need good organ function and a negative pregnancy test if applicable. People with serious infections, lung fibrosis, uncontrolled heart conditions, recent major surgery or certain mental health risks can't join.Check my eligibility
What is being tested?
The study compares two drugs: Lorlatinib and Crizotinib as first-line treatments for NSCLC. It aims to see if Lorlatinib is better at delaying cancer progression without the disease getting worse and will also look at overall survival rates compared to Crizotinib.See study design
What are the potential side effects?
Possible side effects of both Lorlatinib and Crizotinib include liver problems, nausea, diarrhea, vision disorders, swelling due to fluid retention, fatigue, neuropathy (nerve pain or numbness), cognitive effects like confusion or memory issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have not received any systemic treatment for NSCLC.
Select...
I am 18 years old or older.
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I can take care of myself but may not be able to do heavy physical work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from time of study start up to 45 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from time of study start up to 45 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-Free Survival (PFS) Based on Blinded Independent Central Review (BICR) Assessment
Secondary outcome measures
Therapeutic procedure
Change From Baseline in Health Status as Assessed by EuroQol 5 Dimension 5 Level (EQ-5D-5L) - Index Across Time
Change From Baseline in Health Status as Assessed by EuroQol 5 Dimension 5 Level (EQ-5D-5L) - Visual Analogue Scale (VAS) Across Time
+24 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
2Treatment groups
Experimental Treatment
Active Control
Group I: LorlatinibExperimental Treatment1 Intervention
Lorlatinib single agent, 100 mg (4 x 25 mg) oral tables, QD, continuously
Group II: CrizotinibActive Control1 Intervention
Crizotinib single agent, 250 mg (1 x 250) oral capsules, BID, continuously
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
4,567 Previous Clinical Trials
10,911,577 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,474 Previous Clinical Trials
8,092,745 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any ongoing infections.I have not received any systemic treatment for NSCLC.I haven't taken certain strong medications or specific foods that affect drug metabolism in the last 12 days.I am 18 years old or older.My bone marrow, liver, kidneys, and pancreas are functioning well.I have spinal cord compression but my pain is well managed.I have not had major surgery in the last 4 weeks.You have a serious medical or mental health condition, including recent thoughts of suicide, or abnormal lab results that could make it risky for you to participate in the study.There is a stored tissue sample available for the study.I have not had any type of brain radiation in the last 2 to 4 weeks.My lung cancer is ALK-positive with at least one measurable lesion outside the brain.I have severe lung scarring or disease affecting both lungs.Women who can have children must have a negative pregnancy test.I haven't had any cancer other than NSCLC or minor skin, cervical, thyroid, breast, or prostate cancers in the last 3 years.I can take care of myself but may not be able to do heavy physical work.I have had serious heart problems or irregular heartbeats in the last 3 months.I have had risk factors for acute pancreatitis in the last month.
Research Study Groups:
This trial has the following groups:- Group 1: Lorlatinib
- Group 2: Crizotinib
Awards:
This trial has 2 awards, including:- 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.
Is this the first study of its kind?
"Since 2011, when the first clinical study on lorlatinib was conducted, this medication has undergone extensive research. The first 44-person trial was sponsored by Pfizer and, following its success, lorlatinib received Phase 1 drug approval. Now, 47 clinical trials are ongoing in 1221 cities across 37 countries."
Answered by AI
Does Lorlatinib have any serious side effects?
"This particular medication, Lorlatinib, is in Phase 3 of clinical trials. This means that while there is data supporting its efficacy, there is also multiple rounds of data affirming its safety. Consequently, our team at Power rates Lorlatinib as being a 3 in terms of safety."
Answered by AI
Could you provide some context regarding Lorlatinib research?
"53 clinical trials studying lorlatinib have been completed since 2011, with 47 more ongoing. A large proportion of these studies are being conducted in Dickson, Florida."
Answered by AI
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