Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Afatinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

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

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

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%

Talcum powder

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.

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%.

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)

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.

Center Trials & Treatment

Center Trials & Treatment Europe

Symptoms and General Pathology

Rare Diseases

Pain

Mesothelioma

Mesothelioma, Malignant

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Mesothelial

Pleural Neoplasms

Malignant Mesothelioma

After pleurectomy decortication, Progel® sealant added to the surface of the lung prior to closure of the chest. Participants complete pain scale 3 times each day while in the hospital.

After pleurectomy decortication, talcum powder added to the surface of the lung prior to closure of the chest. Participants complete pain scale 3 times each day while in the hospital.

After pleurectomy decortication, Progel® sealant added to the surface of the lung prior to closure of the chest.

Progel Sealant

After pleurectomy decortication, talcum powder added to the surface of the lung prior to closure of the chest.

Talcum Powder

Participants complete pain scale 3 times each day while in the hospital. Pain is rated on a pain scale of 0 - 10.

Pain Questionnaire

Reza J. Mehran, MD

The goal of this clinical research study is to compare Progel® (a type of surgical sealant that is made from human blood products) to the standard of care (talcum powder) to learn if one method is better than the other for preventing air leaks in patients having a pleurectomy decortication.

If participant agrees to take part in this study, they will have their pleurectomy decortication as planned. Participant will sign a separate consent for this procedure that explains the risks.

At the time of participant's surgery, sutures and staples are used to help correct air leaks, which is standard.

Then, participant will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group:

* One group will have Progel® added to the surface of the lung before closing the chest.
* The other group will have talcum powder added to the surface of the lung before closing the chest.

Participant will have an equal chance of being in either group.

During the surgery, air leaks will be checked electronically and that information will be recorded.

After surgery, participant will be asked to rate their pain on a pain scale of 0-10. Participant will be asked to complete this pain scale 3 times each day while they are in the hospital.

Length of Study Participation:

After participant's surgery and their air leak is resolved, their participation in this study will be over.

This is an investigational study. The Progel® surgical sealant is FDA approved for the control of air leaks during lung surgery. It is investigational to compare the surgical sealant with the standard-of-care (talcum powder) to learn if it can reduce the number of days in the hospital after surgery.

Up to 48 participants will enrolled in this study. All will take part at MD Anderson.

Comparison of Progel Sealant to Standard of Care (SOC) for Patients Undergoing Decortication

A Randomized Phase III Trial to Compare the Progel Sealant to Standard of Care (SOC) for Patients Undergoing Decortication for Mesothelioma or Other Pathologies

Primary outcome is T = time to resolve an air leak in the lungs, allowing the possibility that an air leak may not develop, represented by T=0.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Dry Pleurodesis With Talcum and Afatinib is Used to Treat Patients With Non-Small Cell Lung Carcinoma	NCT03827070	Non Small Cell ...	Afatinib Talcum powder	21 Years - 40 Years	Center Trials & Treatment Europe
Comparison of Progel Sealant to Standard of Care (SOC) for Patients Undergoing Decortication	NCT02511600	Lung Diseases Mesothelioma	Progel Sealant Talcum Powder Pain Questionna...	18 Years -	M.D. Anderson Cancer Center
Dry Pleurodesis With Talcum and Afatinib is Used to Treat Patients With Non-Small Cell Lung Carcinoma	NCT03827070	Non Small Cell ...	Afatinib Talcum powder	21 Years - 40 Years	Center Trials & Treatment Europe

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