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ALK Inhibitor

Lorlatinib for Non-Small Cell Lung Cancer

Phase 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 2 years

Awards & highlights

Study Summary

This trial will test the safety and effectiveness of the lorlatinib in treating patients with ALK-positive or ROS1-positive non-small cell lung cancer (NSCLC).

Eligible Conditions

Non-Small Cell Lung Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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

Intracranial Disease Control Rate (DCR)

Secondary outcome measures

Intracranial Objective Response Rate (ORR)

Median Intracranial Duration of Response (DOR)

Median Overall Survival

+4 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%

Study treatment Arm

Normal Function

Mild Impairment

Moderate Impairment

Severe Impairment

Trial Design

1Treatment groups

Experimental Treatment

Group I: LorlatinibExperimental Treatment1 Intervention

Lorlatinib will be administered orally once daily on a 21 day cycle Blood will be collected for biomarker studies

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lorlatinib

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,932 Previous Clinical Trials

13,198,465 Total Patients Enrolled

Ibiayi Dagogo-Jack, MDPrincipal Investigator - Massachusetts General Hospital

Brigham & Women's Hospital, Massachusetts General Hospital, Massachusetts General Physicians Organization Inc

1 Previous Clinical Trials

96 Total Patients Enrolled

Frequently Asked Questions

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

Are there opportunities available for participants in this research project?

"The trial, which was initially published on October 1st 2016 and revised most recently on March 7th 2021, is actively seeking participants. Data hosted by clinicaltrials.gov supports this claim."

Answered by AI

Has Lorlatinib been officially greenlighted by the FDA?

"Lorlatinib's safety is estimated to be a 2, as there is some evidence of it being safe, yet no proof that it produces the desired clinical effect."

Answered by AI

Is this the inaugural research of its kind?

"As of today, there are 16 ongoing trials for Lorlatinib on a worldwide scale. The initial research first began in 2016 by Janssen LP and included 1550 participants across 432 cities from 26 nations. It has since progressed to Phase 2 drug approval; 12 studies have been concluded thus far."

Answered by AI

What other exploration has been done with regards to Lorlatinib?

"At present, 16 clinical trials are in-progress examining Lorlatinib. Of these studies, one is being undertaken at the Phase 3 level. The bulk of investigative centres for this drug are based in Goyang-Si, Gyeonggi-do; however 872 trial sites around the world are assessing its efficacy."

Answered by AI

What is the total enrollment quota for this research endeavor?

"Affirmative, clinicaltrials.gov demonstrates that this medical trial is still open to participants. It was first posted on October 1st 2016 and recently updated on March 7th 2021. 30 individuals need to be enlisted from a single site for the study's completion."

Answered by AI

Recent research and studies

JCO Precision OncologyJournal

Phase II Study of Lorlatinib in Patients with Anaplastic Lymphoma Kinase–positive Lung Cancer and Cns-specific Relapse

Dagogo-Jack, Ibiayi, Geoffrey R. Oxnard, Makenzi Evangelist, Subba R. Digumarthy, Jessica J. Lin, Justin F. Gainor, John F. Murphy, et al.. 2022. “Phase II Study of Lorlatinib in Patients with Anaplastic Lymphoma Kinase–positive Lung Cancer and Cns-specific Relapse”. JCO Precision Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/po.21.00522.

clinicaltrials.govStudy

A Study of Lorlatinib in Advanced ALK and ROS1 Rearranged Lung Cancer With CNS Metastasis in the Absence of Measurable Extracranial Lesions

Ibiayi Dagogo-Jack, M.D. 2016. "A Study of Lorlatinib in Advanced ALK and ROS1 Rearranged Lung Cancer With CNS Metastasis in the Absence of Measurable Extracranial Lesions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02927340.

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