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

NCT03827070 | Unknown Phase 1 DMC

• 1 other identifier: 9TJJ425H1D
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Small Cell Lung Cancer

Keywords

Afatinib; Talcum powder; Thoracoscopy; Pleurodesis; BIBW2992

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Talcum powder & Afatinib

EXPERIMENTAL

Talcum powder 4 g + Afatinib 0,4 g. Is entered once

Drug: Afatinib; Drug: Talcum powder

Interventions

Afatinib DRUG

Used Afatinib particles of which had an average size of 22 μm and a volume concentration of small particles (\<5 μm) - only 19%

Also known as: BIBW2992

Talcum powder & Afatinib

Talcum powder DRUG

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%

Also known as: Talc

Talcum powder & Afatinib

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Center Trials & Treatment Europe: lead
• Center Trials & Treatment: collaborator

Study Sites (1)

Central Contact

Tbilisi, 0008, Georgia

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Afatinib; Talc

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Magnesium Silicates; Magnesium Compounds; Inorganic Chemicals; Silicates; Minerals; Silicic Acid; Silicon Dioxide; Silicon Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: None (Open Label)
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: February 1, 2019
• Study Start: March 5, 2019
• Primary Completion: February 21, 2023
• Study Completion: July 21, 2023
• Last Updated: April 25, 2023

Record last verified: 2023-04

Locations

GE (1)