A Phase 1 interventional study of Afatinib and Talcum powder in Non Small Cell Lung Cancer, sponsored by Center Trials & Treatment Europe. Status unknown at 1 site in Georgia. Open to male participants aged 21 Years to 40 Years. Per ClinicalTrials.gov, last updated 2023-04-25.
Sponsored by Center Trials & Treatment Europe · Phase 1, Interventional, and Treatment
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:
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%.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's enrollment of 12 is below the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Center Trials & Treatment Europe is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Talcum powder 4 g + Afatinib 0,4 g. Is entered once
Drug: Afatinib · Drug: Talcum powder
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
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
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.
Time frame: up to 90 days
This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
Center Trials & Treatment Europe