Clinical trial NCT03827070: Dry Pleurodesis With Talcum and Afatinib is Used to Treat Patients With Non-Small Cell Lung Carcinoma
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Non Small Cell Lung Cancer
Keywords: Afatinib
Talcum powder
Thoracoscopy
Pleurodesis
BIBW2992
Lead sponsor: Center Trials & Treatment Europe
Sponsor class: NETWORK
Collaborators: name: Center Trials & Treatment
First posted: 2019-02-01
Enrollment: 12
Sex: MALE
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment
Primary purpose: TREATMENT

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%.

Eligibility criteria: 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

Primary outcomes:
measure: The effectiveness of the procedure of dry pleurodesis through a thoracoscope
timeFrame: up to 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tbilisi
country: Georgia
facility: Central Contact
Study officials:
References: