A Phase 1 interventional study of Tirzepatide in Lung Cancer, sponsored by University of Chicago. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by University of Chicago · Phase 1, Interventional, and Treatment
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.
5,422 studies on the registry are indexed under Lung Neoplasms; 1,346 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 3,656 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →University of Chicago is the lead sponsor of 924 studies on the registry; 185 are open to participants now.
Of its 103 completed or terminated interventional studies of FDA-regulated products, 72 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Individuals taking with an body mass index (BMI) in obese range (BMI greater than or equal to 30) or those with a BMI greater than or equal to 27 and with cardiac risk factors will receive tirzepatide starting after study enrollment. Individuals that do not meet these BMI criteria will start tirzepatide if they experience weight gain of 5% of more during the study. Statistical analysis will include all participants that receive tirzepatide on this study.
Drug: 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.
Also known as: Monjouro, Zepbound
Body weight changes
To assess the effect of tirzepatide, on change in body weight in patients taking lorlatinib.
Time frame: 1 year post treatment start
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.
Time frame: 1 year post treatment start
Change in Cmax
Determine if the peak concentration of Lorlatinib is significantly altered when co-administered with tirzepatide.
Time frame: 1 year post treatment start
Change in Tmax
Assess if the time to peak concentration is delayed due to tirzepatide's effect on gastric emptying.
Time frame: 1 year post treatment start
Bioavailability
Evaluate partial AUC to estimate the extent of drug absorption.
Time frame: 1 year post treatment start
Rate of metabolic side effects
Number of Common Terminology Criteria for Adverse Events (CTCAE) Grade 1-3 metabolic side effects
Time frame: 1 year from start of treatment
Changes in body mass composition
Changes in body mass will be measured using Bioelectrical Impedance Analysis (BIA).
Time frame: 1 year from start of treatment
Changes in waist circumference
Time frame: 1 year from start of treatment
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))
Time frame: 1 year from start of treatment
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Tirzepatide