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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 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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My bone marrow, liver, kidneys, and pancreas are functioning well.
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My lung cancer is ALK-positive with at least one measurable lesion outside the brain.
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I can take care of myself but may not be able to do heavy physical work.

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

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 more

Side effects data

From 2020 Phase 1 trial • 29 Patients • NCT03542305
13%
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

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

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
Recent research and studies
~37 spots leftby Apr 2025