Orlistat Overcoming Third-generation EGFR-TKI Resistance

Launched by PING PENG · Feb 8, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to help patients with lung adenocarcinoma, particularly those who have developed resistance to a common treatment called osimertinib. Researchers are testing whether adding a medication called orlistat, which is usually used for weight loss, can help these patients respond better to osimertinib without causing significant side effects. The goal is to provide a treatment option for patients who prefer to continue taking targeted medications orally instead of undergoing more intense chemotherapy.

To be eligible for this trial, participants should have already received treatment with third-generation targeted therapies and developed resistance to them. They should also have a good overall health status, be expected to live for at least three more months, and have certain blood test results within specific limits. Patients who have serious medical conditions, brain metastases with symptoms, or are pregnant or breastfeeding cannot participate. If you or a loved one is interested in this trial, it could be a chance to explore a new treatment approach aimed at improving outcomes with fewer side effects.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Previously received three generations of systemic TKI treatment and developed resistance (including Axitinib, Amitinib, Fumatinib, Bevatinib, Lazetinib, etc.);
• • 2. General condition score ECOG 0-2 points;
• • 3. Expected survival period of more than 3 months;
• 4. Laboratory examination:
• • ① WBC≥3.5×109／L，ANC≥1.5×109／L，PLT≥80×109／L， Hb≥90g/L；
• • ② Blood BUN and creatinine are within 1.5 times the upper limit of normal values;
• • ③ TBIL ≤ 1.5 times the upper limit of normal value;
• • ④ ALT and AST ≤ 2.5 times the upper limit of normal values; Patients with liver metastasis should not exceed 5 times the upper limit of normal values;
• • ⑤ Normal coagulation function (PT, APTT within 1.5 times the upper limit of normal range).
• • 5. The patient requests to continue taking targeted drugs orally
• • 6. Voluntarily sign the informed consent form, with expected compliance.
• Exclusion Criteria:
• • 1. Suffering from serious medical diseases, including serious heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, serious infection, and active gastrointestinal ulcer;
• • 2. A large amount of pleural and pericardial effusion requires immediate treatment;
• • 3. Brain metastases with clinical symptoms;
• • 4. Pregnant or lactating women;
• • 5. The patient is able to tolerate chemotherapy and is willing to accept it