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

Non Small Cell Lung Cancer Clinical Trial

— DPTA  

Official title:

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03827070
• Other study ID #: 9TJJ425H1D
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: March 5, 2019
• Est. completion date: July 21, 2023

Study information

• Verified date: April 2023
• Source: Center Trials & Treatment Europe
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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%.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: July 21, 2023
• Est. primary completion date: February 21, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 21 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

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%
• 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%

Locations

Country	Name	City	State
Georgia	Central Contact	Tbilisi

Sponsors (2)

Lead Sponsor	Collaborator
Center Trials & Treatment Europe	Center Trials & Treatment

Country where clinical trial is conducted

Georgia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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