Non Small Cell Lung CancerPhase 1DPTANCT03827070
Dry Pleurodesis With Talcum and Afatinib is Used to Treat Patients With Non-Small Cell Lung Carcinoma
A Phase 1 study testing Afatinib and Talcum powder in people with Non Small Cell Lung Cancer, run by Center Trials & Treatment Europe at 1 site in Georgia.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 40 years, men only
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Afatinib and Talcum powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteGeorgia
- Study dates
- 5 Mar 2019to 21 Jul 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 40 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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%.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Afatinib, Talcum powder
- Keywords
- Afatinib, Talcum powder, Thoracoscopy, Pleurodesis, BIBW2992
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AfatinibDrug
Also called BIBW2992
Used Afatinib particles of which had an average size of 22 μm and a volume concentration of small particles (<5 μm) - only 19%
Talcum powderDrug
Also called Talc
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%
| Study group | Role | What they receive |
|---|---|---|
| Talcum powder & Afatinib | Experimental | Talcum powder 4 g + Afatinib 0,4 g. Is entered once Receives: Drug: Afatinib; Drug: Talcum powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start5 Mar 2019
- Primary completion21 Feb 2023
- Study completion21 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center Trials & Treatment Europe
- Sponsor type
- Research network
- Collaborators
- Center Trials & Treatment
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03827070
- Sponsor's protocol ID
- 9TJJ425H1D
- Acronym
- DPTA
- Status last verified
- Apr 2023
- First submitted
- 29 Jan 2019
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03827070
- Acronym / sponsor ID
- DPTA / 9TJJ425H1D
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Afatinib, Talcum powder, Thoracoscopy, Pleurodesis, BIBW2992
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Center Trials & Treatment EuropeResearch network
- Collaborators
- Center Trials & Treatment
- Study start
- 5 Mar 2019 (actual)
- Primary completion
- 21 Feb 2023 (actual)
- Study completion
- 21 Jul 2023 (estimated)
- First posted
- 1 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Talcum powder & Afatinib | Experimental | Drug: Afatinib, Drug: Talcum powderTalcum powder 4 g + Afatinib 0,4 g. Is entered once |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AfatinibAlso: BIBW2992Used Afatinib particles of which had an average size of 22 μm and a volume concentration of small particles (<5 μm) - only 19% | Drug | Talcum powder & Afatinib |
| Talcum powderAlso: TalcUsed Talcum powder particles of which had an average size of 24.5 μm and a volume concentration of small particles (<5 μm) - only 11% | Drug | Talcum powder & Afatinib |
Primary outcome
The effectiveness of the procedure of dry pleurodesis through a thoracoscope
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Afatinib and Talcum powder in people with Non Small Cell Lung Cancer, run by Center Trials & Treatment Europe at 1 site in Georgia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effectiveness of the procedure of dry pleurodesis through a thoracoscope (time frame: up to 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.