Tirzepatide for Lung Cancer
(NSCLC Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Marina Garassino
Principal Investigator
University of Chicago
Are You a Good Fit for This Trial?
This trial is for adults with advanced ALK-positive non-small cell lung cancer who are already taking lorlatinib as their first treatment. People can't join if they use certain diabetes or weight loss drugs, have a history of pancreatitis, thyroid cancer risk, severe mental illness, organ problems, or are pregnant or breastfeeding.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants with NSCLC receiving lorlatinib will receive tirzepatide to address metabolic derangements and weight gain
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Tirzepatide
Trial Overview
The study tests whether adding tirzepatide (a medication that helps with weight and metabolism) can reduce side effects like rapid weight gain in lung cancer patients already on lorlatinib. All participants continue their usual lorlatinib treatment.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Chicago
Lead Sponsor
Pfizer
Industry Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University
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