Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07782359

Impact of Using a GLP1 on Treatment Related Side Effects of Lung Cancer Patients Receiving Lorlatinib

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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location contact

Clinical Trials Intake

CONTACT

[email protected]

855-702-8222

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Monjouro, Zepbound

Primary outcomes

  1. Body weight changes

    Time frame: 1 year post treatment start

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

  2. Lipid changes

    Time frame: 1 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.

  3. Change in Cmax

    Time frame: 1 year post treatment start

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

  4. Change in Tmax

    Time frame: 1 year post treatment start

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

  5. Bioavailability

    Time frame: 1 year post treatment start

    Evaluate partial AUC to estimate the extent of drug absorption.

Secondary outcomes

  1. Rate of metabolic side effects

    Time frame: 1 year from start of treatment

    Number of Common Terminology Criteria for Adverse Events (CTCAE) Grade 1-3 metabolic side effects

  2. Changes in body mass composition

    Time frame: 1 year from start of treatment

    Changes in body mass will be measured using Bioelectrical Impedance Analysis (BIA).

  3. Changes in waist circumference

    Time frame: 1 year from start of treatment

  4. Changes in cardiometabolic markers

    Time frame: 1 year from start of treatment

    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))

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Intake Intake

CONTACT

[email protected]

855-702-8222

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • Pfizer

Registry information

Official study title

Impact of Tirzepatide on Lorlatinib-Associated Weight Gain and Metabolic Derangements in Patients With Non-Small Cell Lung Cancer (NSCLC)

Acronym: NSCLC

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Aug 24, 2026
Registry last updated
Aug 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.