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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
All Individual Drugs Already Approved
No Placebo-Only Group

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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Intracranial Disease Control Rate (DCR)
Secondary study objectives
Median Intracranial Duration of Response (DOR)
Median extra-cranial PFS

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
Mild Impairment
Severe Impairment
Normal Function

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,008 Previous Clinical Trials
13,307,372 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
~3 spots leftby Nov 2025
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