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

Opening soonPhase 1Interventional

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionLung Cancer

Full registry criteria

Inclusion Criteria: * Age ≥ 18 years * Receiving lorlatinib as first-line treatment for advanced NSCLC ALK-positive, already prescribed and administered by the patient's treating oncologist as standard of care at the time of study enrollment. This study does not initiate lorlatinib therapy or assign lorlatinib dosing; participants must already be receiving lorlatinib prior to enrollment Exclusion Criteria: * Known hypersensitivity to GLP-1 agonists. * Active, unstable psychiatric illness; current suicidal ideation * Severe organ dysfunction or systemic illness. * Anorexia nervosa * History of pancreatitis * Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 * Current use of Glucagon-Like Peptide-1 Receptor Agonists (GLP-1 RA) or glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) \[GLP-1 RA/GIP\] co-agonist use within the last 90 days prior to screening * Current anti-obesity medication use (other than GLP-1 RA) or dipeptidyl peptidase-4 (DPP4) inhibitor use or use within the last 30 days prior to screening * Pregnant, breastfeeding or planning pregnancy

Treatments and study arms

Tirzepatide

Drug

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

Body weight changes1 year post treatment start

To assess the effect of tirzepatide, on change in body weight in patients taking lorlatinib.

Lipid changes1 year post treatment start

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.

Change in Cmax1 year post treatment start

Determine if the peak concentration of Lorlatinib is significantly altered when co-administered with tirzepatide.

Change in Tmax1 year post treatment start

Assess if the time to peak concentration is delayed due to tirzepatide's effect on gastric emptying.

Bioavailability1 year post treatment start

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.

University of Chicago Medicine Comprehensive Cancer Center🇺🇸 Chicago, Illinois, United States
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