NCT03827070

Dry Pleurodesis With Talcum and Afatinib is Used to Treat Patients With Non-Small Cell Lung Carcinoma

New Method of Treatment for Thoracoscopy or Bronchoscopy by Suspension of Fine Powder of Talcum and Afatinib is Used in Patients With Positive Mutation of EGFR in Non-Small Cell Lung Carcinoma (NSCLC)

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Center Trials & Treatment Europe · Network
• Sex: Male
• Age: 21 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Detailed 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%.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Afatinib	Used Afatinib particles of which had an average size of 22 μm and a volume concentration of small particles (\<5 μm) - only 19%
DRUG	Talcum powder	Used Talcum powder particles of which had an average size of 24.5 μm and a volume concentration of small particles (\<5 μm) - only 11%

Timeline

• Start date: 2019-03-05
• Primary completion: 2023-02-21
• Completion: 2023-07-21
• First posted: 2019-02-01
• Last updated: 2023-04-25

Locations

1 site across 1 country: Georgia