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Clinical Trial Summary

In non-small cell lung cancer and metastases in the pleural cavity, pathological effusion is formed. Currently, the most common and effective method of obliteration of the pleural cavity is pleurodesis with talcum powder. Talc, when it surface of the pleura, causes chemical inflammation that leads to the soldering of the lungs and chest wall. As a result, the liquid ceases to accumulate. The addition of a therapeutic dose of afatinib to talc not only blocks effusion into the pleural cavity, but also reduces tumor and metastatic processes.


Clinical Trial Description

The proposed procedure for dry pleurodesis consists of one stage. Talc is introduced into the pleural cavity in several ways: - Drainage - a tube is inserted into the pleural cavity through a puncture in the chest, and then a pasty talcum is delivered into the cavity, which spreads through the cavity during the change of the patient's body position. - Talcum powder - under the control of thoracoscopy, dry talc is blown into the pleural cavity of the patient, which allows him to evenly distribute and significantly increases the effectiveness of the procedure. In this Clinical Trial investigators will use the method of thoracoscopy - the blow in of talcum powder and therapeutic dose of Afatinib. Before injection, a suspension of talc and afatinib is subjected to the procedure of pharmaceutical mixing. The operation is well tolerated by participants and lasts no more than 30 minutes. The effectiveness of the method is 90%. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03827070
Study type Interventional
Source Center Trials & Treatment Europe
Contact
Status Active, not recruiting
Phase Phase 1
Start date March 5, 2019
Completion date July 21, 2023

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