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Lorlatinib for Lung Cancer

Phase 4
Recruiting
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 adequate Bone Marrow, Liver, Renal, and Pancreatic Function
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to approximately 5 years
Awards & highlights

Study Summary

This trial will provide continued lorlatinib treatment and safety monitoring to those who benefit from it, to further understand its safety profile.

Who is the study for?
This trial is for individuals with non-small cell lung cancer who are benefiting from ongoing Lorlatinib treatment in previous Pfizer studies. They must have good bone marrow, liver, kidney, and pancreatic function and agree to follow reproductive guidelines. Pregnant or breastfeeding women can't participate.Check my eligibility
What is being tested?
The study continues providing Lorlatinib to patients from prior trials who still benefit from it. It aims to gather more safety data on the long-term use of Lorlatinib in treating non-small cell lung cancer.See study design
What are the potential side effects?
While specific side effects aren't listed here, common ones associated with Lorlatinib may include swelling, weight gain, mood effects, nerve damage causing tingling or pain, and high cholesterol levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My bone marrow, liver, kidneys, and pancreas are functioning well.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to approximately 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to approximately 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with adverse events leading to permanent discontinuation of study intervention
Number of serious adverse events reported for all participants

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

1Treatment groups
Experimental Treatment
Group I: LorlatinibExperimental Treatment1 Intervention
Lorlatinib single agent, 100 mg (4 x 25 mg) oral tables, QD, 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
4,562 Previous Clinical Trials
10,906,776 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,471 Previous Clinical Trials
8,088,167 Total Patients Enrolled

Media Library

Lorlatinib Clinical Trial Eligibility Overview. Trial Name: NCT05144997 — Phase 4
Non-Small Cell Lung Cancer Research Study Groups: Lorlatinib
Non-Small Cell Lung Cancer Clinical Trial 2023: Lorlatinib Highlights & Side Effects. Trial Name: NCT05144997 — Phase 4
Lorlatinib 2023 Treatment Timeline for Medical Study. Trial Name: NCT05144997 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the capacity of this experiment in terms of participants?

"Affirmative. Clinicaltrials.gov displays that this medical trial, which appeared on December 28th 2021 remains active and is currently recruiting participants. 200 individuals are being enrolled from a single medical centre."

Answered by AI

Could you please elucidate the potential risks associated with Lorlatinib?

"Lorlatinib has already been approved by the FDA, so its safety level is rated a 3."

Answered by AI

Is this clinical research program currently enrolling participants?

"According to information hosted on clinicaltrials.gov, enrollment is presently ongoing for this medical trial which was first publicized on December 28th 2021 and last revised on February 22nd 2023."

Answered by AI

Does this clinical research represent a pioneering effort?

"Presently, 17 trials for Lorlatinib are being conducted in 440 cities and 26 nations. The pioneer investigation of this drug occurred in 2016 when Amgen sponsored a trial with 1550 participants which eventually culminated in Phase 2 FDA clearance. Since then, 12 such studies have been completed."

Answered by AI

Has any other experimentation been done with Lorlatinib?

"Currently, there are 17 ongoing lorlatinib clinical trials with 1 in the third stage of testing. Broadly based out of Boston, Massachusetts these tests can be found at 901 different medical sites around the world."

Answered by AI
~107 spots leftby Dec 2026