Clinical trial
Impact of Using a GLP1 on Treatment Related Side Effects of Lung Cancer Patients Receiving Lorlatinib
Opening soon · Phase 1 · 1 countries · Registry ID NCT07782359
What this study is about
The proposed study seeks to address a critical gap in the management of lorlatinib-induced metabolic derangements, particularly rapid weight gain, which can adversely affect treatment adherence, dosing and ultimately patient outcomes. In this study patients with non-small cell lung cancer (NSCLC) receiving lorlatinib treatment will receive tirzepatide, a dual GIP/GLP-1 receptor agonist with demonstrated efficacy in weight reduction and metabolic improvement. This study seeks to evaluate its potential to mitigate side effects while preserving the therapeutic efficacy of lorlatinib.
Basic eligibility
Full registry criteria
Treatments and study arms
Tirzepatide
Participants will receive tirzepatide with weekly subcutaneous injections at 2.5 mg, following a structured dose escalation protocol over 20 weeks to reach the target dose of 15 mg per week or the maximum tolerated dose.
Primary outcomes
To assess the effect of tirzepatide, on change in body weight in patients taking lorlatinib.
To assess the effect of tirzepatide on change in lipid profile High-density lipoprotein (HDL), low-density lipoprotein (LDL), total cholesterol, triglycerides) at 52 weeks compared to baseline.
Determine if the peak concentration of Lorlatinib is significantly altered when co-administered with tirzepatide.
Assess if the time to peak concentration is delayed due to tirzepatide's effect on gastric emptying.
Evaluate partial AUC to estimate the extent of drug absorption.
Study locations
1 locations were listed when this page was built. The first 40 are shown.