Clinical trial · Interventional
Impact of Using a GLP1 on Treatment Related Side Effects of Lung Cancer Patients Receiving Lorlatinib
Impact of Tirzepatide on Lorlatinib-Associated Weight Gain and Metabolic Derangements in Patients With Non-Small Cell Lung Cancer (NSCLC)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tirzepatide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tirzepatide Treatment
- description
- 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.
- interventionNames
- Drug: Tirzepatide
Primary outcomes (5)
- measure
- Body weight changes
- timeFrame
- 1 year post treatment start
- description
- To assess the effect of tirzepatide, on change in body weight in patients taking lorlatinib.
- measure
- Lipid changes
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available