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RecruitingPhase 1

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether tirzepatide can reduce side effects of lorlatinib, especially rapid weight gain, while keeping the cancer treatment working. It is for adults with advanced non-small cell lung cancer who are already taking 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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 or older.
  • You have advanced non-small cell lung cancer that is ALK-positive, meaning it has a change in the ALK gene.
  • You are already taking lorlatinib as your first treatment for this cancer, prescribed by your cancer doctor. The study does not start lorlatinib or choose its dose.

Who can't join

  • You have a known allergy to GLP-1 medicines.
  • You have a mental health illness that is active and not stable, or you currently have thoughts of suicide.
  • You have severe organ problems or a serious illness affecting your whole body.
  • You have anorexia nervosa, an eating disorder, or have had pancreatitis, which is swelling of the pancreas.
  • You or a family member has had medullary thyroid cancer or multiple endocrine neoplasia type 2, a condition that causes tumors in glands that make hormones.
  • You currently use a GLP-1 medicine or a combined GIP/GLP-1 medicine, or used one within 90 days before screening.
  • You currently use another weight-loss medicine or a DPP-4 inhibitor, a type of diabetes medicine, or used one within 30 days before screening.
  • You are pregnant, breastfeeding, or planning to become pregnant.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

IL