Loading search results
OOTER
Clinical Study on the Safety and Efficacy of Orlistat in Third-generation EGFR-TKI Resistance
Sponsor study identifier
interventional
36
0 countries
N/A
Study Start
February 16, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
May 15, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 15, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
EGFR mutation positivity accounts for 50% of lung adenocarcinoma cases. Multiple clinical trials, represented by FLAURA, AENEAS, and FURLONG studies, have confirmed that third-generation EGFR-TKI can provide significant benefits to patients with EGFR sensitive mutations and has become the first-line preferred treatment for EGFR mutation positive NSCLC, with a median PFS of around 19 and OS of around 38 months. These large-scale Phase III studies have confirmed the excellent efficacy of third-generation EGFR-TKI in EGFR mutation positive patients. However, regardless of the targeted drug, resistance will occur within less than 2 years. Blood test data for first-line treatment with osimertinib showed that the most common forms of resistance were secondary MET amplification (20%), EGFR C797S mutation (8%), PIK3CA, Her-2 amplification, and so on. The mechanism of resistance is complex and has many factors. Currently, for the treatment of third-generation EGFR-TKI resistance, the IMPOWER150 and ORIENTAL31 treatment modes are commonly used. Although the combination of these four drugs has good efficacy, the side effects are significant. Some patients are unwilling to undergo chemotherapy due to physical problems and hope to continue taking targeted drugs orally. Orlistat is a long-acting and potent specific gastrointestinal lipase inhibitor that can directly block the absorption of body fat. It is commonly used for weight loss in clinical practice and is relatively inexpensive. Our project team found in vitro and in vivo data that orlistat can effectively promote sensitivity to osimertinib. The combination of orlistat and osimertinib can overcome osimertinib resistance without significant toxic side effects. For patients who are unwilling to undergo chemotherapy and require continued oral targeted therapy, the investigators attempted to add orlistat to see if it can improve resistance.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 15, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 3, 2025
Actual (reported)February 11, 2025
Actual (reported)February 16, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 15, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 15, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
ORR
Overall response rate (ORR) was defined as the combination of CR and PR.
At the end of cycle 3 (each cycle is 21 days)
Safety (Rate of grade 3 and higher grade treatment-related adverse events)
From date of treatment allocation until treatment completion 30 days
For patients who are resistant to osimertinib and require continued oral administration of targeted drugs, we will add orlistat
First Submitted
February 3, 2025
First Posted
February 11, 2025
Study Start
February 16, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
Contact the study team to confirm eligibility.
May 15, 2025
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 15, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 12, 2025
Record last verified: 2025-02
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: