See if tirzepatide helps with lorlatinib-related weight gain in NSCLC patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1 interventional study enrolling adults with advanced NSCLC who are receiving lorlatinib as part of their standard care. Participants will receive tirzepatide, a dual GIP/GLP-1 receptor agonist, to see if it can lessen lorlatinib-associated weight gain and metabolic changes while maintaining cancer treatment effectiveness. The trial focuses on safety, tolerability, and preliminary signals of efficacy related to weight management and metabolic health. No changes to lorlatinib dosing are made by the study; lorlatinib treatment continues per standard practice. The study excludes individuals with certain medical and psychiatric conditions or prior GLP-1/GIP therapies to minimize risk and confounding factors.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Chicago Medicine Comprehensive Cancer Center
  Chicago, Illinois, United States Recruiting

Study contacts

• Principal investigator: Marina Garassino — University of Chicago
• Study coordinator: Clinical Trials Intake Intake
• Email: cancerclinicaltrials@bsd.uchicago.edu
• Phone: 855-702-8222

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.