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

Study Overview
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Brief Summary
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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
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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%.

Official Title
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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)

Conditions
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Non Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Afatinib
* Drug: Talcum powder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-small cell lung cancer with positive mutation of EGFR verified Malignant pleural effusion Recurrent pleural effusion Complete lung expansion (> 80%) after puncture emptying confirmed by chest radiography. Karnofsky index > 50 Agreed to participate in the study and sign an Informed Consent Exclusion Criteria: Radiotherapy not earlier than 3 months before the pleurodesis procedure Previous surgeries on the same hemitorace Thrombocytopenia or coagulation disorders Trapped lung syndrome Patients with estimated life expectancy < 4-8 weeks Pleural or active systemic infection

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Talcum powder & Afatinib<br>Talcum powder 4 g + Afatinib 0,4 g. Is entered once | Drug: Afatinib<br>* Used Afatinib particles of which had an average size of 22 μm and a volume concentration of small particles (<5 μm) - only 19%<br>* Other names: BIBW2992;Drug: Talcum powder<br>* 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%<br>* Other names: Talc;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effectiveness of the procedure of dry pleurodesis through a thoracoscope | Evaluation of the effectiveness of the dry pleurodesis procedure in combination with talc and afatinib with the introduction of a powder suspension through a thoracoscope. The assessment is performed by CT (computed tomography) of each participant twice: 30 days from the day of the procedure and 90 days later. | up to 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Afatinib, Talcum powder, Thoracoscopy, Pleurodesis, BIBW2992