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

Phase 1

Active, not recruiting

• Conditions: Non Small Cell Lung Cancer
• Interventions: Drug: Afatinib; Drug: Talcum powder

• Registration Number: NCT03827070
• Lead Sponsor: Center Trials & Treatment Europe

Brief 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%.

Study Timeline

• Study First Submitted: 2019-01-29
• Study First Submitted QC: 2019-01-30
• Study First Posted: 2019-02-01
• Study Start: 2019-03-05
• Primary Completion: 2023-02-21
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-23
• Last Update Posted: 2023-04-25
• Study Completion: 2023-07-21

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Talcum powder & Afatinib	Talcum powder	Talcum powder 4 g + Afatinib 0,4 g. Is entered once
Talcum powder & Afatinib	Afatinib	Talcum powder 4 g + Afatinib 0,4 g. Is entered once

Primary Outcome Measures

Name	Time	Method
The effectiveness of the procedure of dry pleurodesis through a thoracoscope	up to 90 days	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.

Trial Locations

Locations (1)

Central Contact; 🇬🇪 Tbilisi, Georgia