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ALK Inhibitor

Lorlatinib for Non-Small Cell Lung Cancer

Phase 1 & 2

Waitlist Available

Led By Ibiayi Dagogo-Jack, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study Summary

This trial is testing the combination of Lorlatinib with Crizotinib, Binimetinib, or TNO155 as potential treatments for ALK-positive or ROS1-positive lung cancer.

Eligible Conditions

Anaplastic Lymphoma Kinase Gene Translocation
ROS1 Rearrangement
Non-Small Cell Lung Cancer
Cancer
Lung Cancer
MET Amplification

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 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

Maximum tolerated dose as assessed by CTCAE v5.0. Phase I.

The objective response rate, including partial and complete responses, as evaluated by RECIST v1.1. Phase II

Secondary outcome measures

Duration of Response to Treatment as Assessed by RECIST v1.1

Therapeutic procedure

Progression-Free Survival as assessed by RECIST v1.1 and the Kaplan-Meier Method

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%

Study treatment Arm

Normal Function

Mild Impairment

Moderate Impairment

Severe Impairment

Trial Design

3Treatment groups

Experimental Treatment

Group I: Lorlatinib and TNO155Experimental Treatment2 Interventions

The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits. The phase I part of the study will follow a standard 3+3 design. Enrollment to the different study arms will occur in parallel. Lorlatinib will be administered orally once daily at a predetermined dose for 21 days TNO155 will be administered orally once daily at a predetermined dose for 14 out of 21 days. Phase II patients will be treated with Lorlatinib + TNO155 at a dose recommended based on the phase I study.

Group II: Lorlatinib and CrizotinibExperimental Treatment2 Interventions

The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits. Phase 1 (the dose-finding portion of the study) will follow a standard 3+3 design. Enrollment to the different study arms will occur in parallel. Lorlatinib will be administered orally once daily at a predetermined dose for 28 days Crizotinib will be administered orally twice daily at a predetermined dose for 28 days Phase II patients will be treated with Lorlatinib and Crizotinib at a dose recommended based on the phase I study.

Group III: Lorlatinib and BinimetinibExperimental Treatment2 Interventions

The research study procedures include screening for eligibility and study treatment. Study treatment will include evaluations, biopsies, and follow up visits. The phase I part of the study will follow a standard 3+3 design. Enrollment to the different study arms will occur in parallel. Lorlatinib will be administered orally once daily at a predetermined dose for 28 days Binimetinib will be administered orally twice daily at a predetermined dose for 28 days. Phase II patients will be treated with Lorlatinib + Binimetinib at a dose recommended based on the phase I study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lorlatinib

FDA approved

Crizotinib

FDA approved

Binimetinib

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Array BioPharmaIndustry Sponsor

28 Previous Clinical Trials

1,301 Total Patients Enrolled

Massachusetts General HospitalLead Sponsor

2,925 Previous Clinical Trials

13,197,808 Total Patients Enrolled

PfizerIndustry Sponsor

4,566 Previous Clinical Trials

10,907,827 Total Patients Enrolled

Frequently Asked Questions

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

What other uses has Lorlatinib been put to in the past?

"At the moment, there are a total of 100 clinical trials researching lorlatinib. Out of those, 9 are currently in phase 3. The largest concentration of these studies is located in Cambridge, England; however, there are 8621 different locations running lorlatinib trials."

Answered by AI

Is this a new or innovative method for conducting research on treatments?

"Work on lorlatinib began in 2011 with a 44 person clinical trial sponsored by Pfizer. After the Phase 1 drug approval in 2011, 100 more people are being studied across 47 different nations and 1413 cities."

Answered by AI

Are we still able to enroll new patients in this research project?

"This is accurate. The clinicaltrials.gov website contains details indicating that this study is still recruiting patients, with the posting dating back to May 1st 2020 and the most recent edit on March 7th 2021. They are looking for 96 individuals total between 2 distinct locations."

Answered by AI

For what purpose is Lorlatinib most often prescribed?

"Lorlatinib is an effective treatment for malignant neoplasms and other conditions like metastatic melanoma, unresectable melanoma, and disease."

Answered by AI

How many people are included in the trial data?

"Yes, as indicated by the clinicaltrials.gov website, this trial is open for recruitment and taking place at two locations. To date, 96 patients have been enrolled in the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Lorlatinib Combinations in Lung Cancer

Ibiayi Dagogo-Jack, M.D. 2020. "Lorlatinib Combinations in Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04292119.