An Early Phase 1 interventional study of Implantable Micro- drug delivery Microdevice (IMD) in Lung Cancer, Mesothelioma and Suspected Lung Cancer, sponsored by Oliver Jonas. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Oliver Jonas · Early Phase 1, Interventional, and Diagnostic
This research is being done to study the safety and feasibility of implanting and retrieving a microdevice that releases microdoses of 20 specific drugs or drug combinations as a possible tool to evaluate the effectiveness of several cancer drugs against lung cancer or mesothelioma.
The name of the intervention(s) involved in this study are:
Implantable Microdevice (IMD) Surgery (excision of tumor) Drugs used in this study will include drugs already used as standard of care for the treatment of lung cancer and mesothelioma, or other drugs that are approved or being investigated for these indications.
This pilot research study is being conducted to evaluate the safety and feasibility of implanting and retrieving investigational drug-releasing microdevices in tumors of patients with lung cancer or malignant mesothelioma. The study will also explore the potential of these microdevices as a tool to assess how individual tumors respond to multiple anticancer drugs and drug combinations.
The microdevices are designed to release very small quantities (microdoses) of selected anticancer drugs directly into spatially distinct regions of a tumor. The drugs evaluated may include treatments currently approved for lung cancer or mesothelioma, as well as drugs approved for other cancer types that are being investigated as potential treatments for these diseases. The purpose of this localized drug exposure is to measure biological responses within the tumor tissue, rather than to provide therapeutic treatment.
The study involves implanting one or more microdevices, each small enough to fit within the tip of a needle, directly into an accessible tumor. The microdevices release microdoses of anticancer drugs through passive diffusion into the surrounding tumor tissue. Drug exposure is intended to remain localized to small regions of the tumor, with minimal systemic exposure.
After approximately 3 days, the microdevices and small regions of surrounding tumor tissue will be retrieved through a planned biopsy or surgical procedure. The collected tissues will be analyzed to evaluate local tumor responses to the individual drugs or drug combinations, including changes in tumor cell viability, cell death, and other biological markers of drug activity.
Research procedures may include screening for eligibility, clinical evaluations, imaging studies, microdevice implantation, tumor tissue sampling, blood collection, and follow-up visits.
The primary objectives of the study are to evaluate the safety and technical feasibility of microdevice implantation, localized drug delivery, and device retrieval in patients with lung cancer or mesothelioma. Exploratory objectives include characterizing tumor responses to multiple anticancer drugs and identifying biological markers associated with drug sensitivity or resistance.
The microdevice is investigational and has not been approved by the U.S. Food and Drug Administration (FDA) for the treatment of any disease. The microdevice-based drug testing procedure is experimental and is not intended to provide direct therapeutic benefit to participants.
Participation in this research study is expected to last up to 4 months.
Approximately 20 participants are expected to enroll, including 10 participants in each of two study cohorts.
7,333 studies on the registry are indexed under Lung Neoplasms; 1,554 are open to participants now.
This study's planned enrollment of 20 is below the median of 60 across 5,345 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Oliver Jonas is the lead sponsor of 5 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
The participant's case must be reviewed by representatives of interventional radiology and the appropriate surgical subspecialty to assess the following factors:
Exclusion Criteria:
Participants with confirmed or suspected lung cancer or malignant mesothelioma who are candidates for standard-of-care surgical tumor resection will be eligible for study participation and will undergo the following study procedures: * \*\*Microdevice implantation:\*\* Placement of 1-4 investigational drug-releasing microdevices into an accessible tumor approximately 72 ± 24 hours prior to scheduled standard-of-care surgery. Microdevices may be implanted using image-guided percutaneous techniques or other clinically appropriate approaches, depending on tumor location and accessibility. The number of microdevices implanted will be determined on a case-by-case basis based on tumor characteristics, anatomical location, procedural feasibility, and participant-specific considerations. * \*\*Microdevice retrieval and tissue collection:\*\* At the time of scheduled standard-of-care surgery, the implanted microdevices will be surgically retrieved along with surrounding tumor tissue and analyzed.
Drug: Implantable Micro- drug delivery Microdevice (IMD)
Small, implantable device with 20 microreservoirs for drug and drug combinations, via needle, percutaneously, and guided by interventional radiologic techniques. Drugs will include selected anticancer agents, such as methotrexate, gemcitabine, pemetrexed, paclitaxel, ipilimumab, nivolumab, pembrolizumab, carboplatin, abemaciclib, vinorelbine, etoposide, and osimertinib.
Safety of microdevice implantation and indwelling
Any grade 4-5 adverse events likely or definitely attributable to device placement, indwelling or retrieval Any death attributable to the study procedures and not attributable to the underlying malignancy or external causes Any device or microdose drug adverse effect resulting in major adverse events as defined in the protocol
Time frame: up to 30 days
Feasibility of assessing tissue responses from microdevice treated tumor regions
We will assess the technical feasibility of retrieving and processing the microdevices with surrounding tissue for downstream research analysis. A device retrieval is defined as successful if at least half of the reservoirs are surrounded by at least 500 microns of tissue.
Time frame: 14 days
No study locations are listed for this record.
Plan to share: Yes — The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: Oliver Jonas, PhD. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Data can be shared no earlier than 1 year following the date of publication.
Access criteria: Contact the Partners Innovations team at http://www.partners.org/innovation.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Oliver Jonas