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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.
Must not have
Active bacterial, fungal, or viral infection
Concurrent use of any of the following food or drugs within 12 days prior to the first dose of lorlatinib or crizotinib: known strong CYP3A inhibitors, known strong CYP3A inducers, known P gp substrates with a narrow therapeutic index, CYP3A substrates with narrow therapeutic indices within 12 days prior to the first dose of lorlatinib or crizotinib.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from time of study start up to 45 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial

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.
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.
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 below
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I have not received any systemic treatment for NSCLC.
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any ongoing infections.
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I haven't taken certain strong medications or specific foods that affect drug metabolism in the last 12 days.
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I have not had major surgery in the last 4 weeks.
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I have not had any type of brain radiation in the last 2 to 4 weeks.
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I have severe lung scarring or disease affecting both lungs.
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I haven't had any cancer other than NSCLC or minor skin, cervical, thyroid, breast, or prostate cancers in the last 3 years.
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I have had risk factors for acute pancreatitis in the last month.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from time of study start up to 45 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from time of study start up to 45 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression-Free Survival (PFS) Based on Blinded Independent Central Review (BICR) Assessment
Secondary study objectives
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 more

Side effects data

From 2020 Phase 1 trial • 29 Patients • NCT03542305
13%
Diarrhoea
13%
Ecchymosis
13%
Dizziness
13%
Headache
13%
Upper respiratory tract infection
13%
Skin abrasion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Moderate Impairment
Severe Impairment
Mild Impairment
Normal Function

Awards & Highlights

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.

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
~530

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,658 Previous Clinical Trials
17,876,991 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,544 Previous Clinical Trials
14,918,167 Total Patients Enrolled

Media Library

Crizotinib (ALK Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03052608 — Phase 3
Non-Small Cell Lung Cancer Research Study Groups: Lorlatinib, Crizotinib
Non-Small Cell Lung Cancer Clinical Trial 2023: Crizotinib Highlights & Side Effects. Trial Name: NCT03052608 — Phase 3
Crizotinib (ALK Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03052608 — Phase 3
~35 spots leftby Nov 2025
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