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.
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
Known hypersensitivity to GLP-1 agonists.
Active, unstable psychiatric illness; current suicidal ideation
Severe organ dysfunction or systemic illness.
Anorexia nervosa
Single group
Tirzepatide
DrugParticipants 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.
Body weight changes
To assess the effect of tirzepatide, on change in body weight in patients taking lorlatinib.
Lipid changes
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 Cmax
Determine if the peak concentration of Lorlatinib is significantly altered when co-administered with tirzepatide.
Change in Tmax
Assess if the time to peak concentration is delayed due to tirzepatide's effect on gastric emptying.
Rate of metabolic side effects
Number of Common Terminology Criteria for Adverse Events (CTCAE) Grade 1-3 metabolic side effects
Changes in body mass composition
Changes in body mass will be measured using Bioelectrical Impedance Analysis (BIA).
Changes in waist circumference
Changes in cardiometabolic markers
The number of participants that experience a change in cardiometabolic markers will be reported. This includes changes in blood tests for any of the following: Hemoglobin A1c (HbA1c), insulin, glucose, Apolipoprotein B (ApoB), homocysteine, C-reactive protein (CRP), and lipoprotein(a) (Lp(a))
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University of Chicago
Lead sponsor
Pfizer
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
