Lung CancerEarly Phase 1NCT07892300
Implantable Microdevices for in Situ Evaluation of Drug Responses in Lung Cancer
A Early Phase 1 study testing Implantable Micro- drug delivery Microdevice (IMD) in people with Lung Cancer and Mesothelioma, run by Oliver Jonas.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Mesothelioma, Suspected Lung Cancer
- What is being tested?
- Implantable Micro- drug delivery Microdevice (IMD)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2026to 30 Oct 2031
- Phase
- Early Phase 1
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have the ability to understand and the willingness to sign a written informed consent document.
- Participants must have confirmed or suspected lung cancer or mesothelioma or other intrathoracic malignancy, and are planned for surgical resection of the tumor as part of their standard clinical care.
- Participants must be 18 years of age or older.
- Participants must be evaluated by a medical oncologist or surgeon who will determine the clinically appropriate treatment strategy based on clinical history and extent of disease.
- Patients must be deemed medically stable to undergo both percutaneous procedures and standard-of-care surgical procedures.
- Participants will undergo laboratory testing within 30 days prior to the procedure (or within 72 hours if there has been a change in the clinical status since the initial blood draw). Patients must have absolute neutrophil count ≥1,000/mcL, platelets ≥120,000/mcL, PT (INR) 1.5 and PTT <1.5x control.
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- Participants must have undergone CT, MRI or other clinical imaging that assesses the extent of disease and allows the research team to assess for study eligibility. This will have been done as part of the standard-of-care.
- The participant's case must be reviewed by representatives of interventional radiology and the appropriate surgical subspecialty to assess the following factors:
- Patient is clinically stable to undergo microdevice implantation and surgical procedures.
- Patient has sufficient volume of disease to allow implantation of the microdevice.
- Patient has a lesion for which the microdevice is a) amenable to percutaneous placement, and b) amenable to removal at the time of surgery.
- Patients must be willing to undergo research-related genetic sequencing (somatic and germline) and data management, including the deposition of de-identified genetic sequencing data in NIH central data repositories.
Who cannot join
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmia, or psychiatric illness/social situations that would limit the safety of a biopsy and/or surgery.
- Uncorrectable bleeding or coagulation disorder known to cause increased risk with surgical or biopsy procedures (detailed below).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Pilot Study of an Implantable Microdevice for in Situ Evaluation of Drug Responses in Lung Cancer
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.
Read the detailed description
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.
- Being tested
- Implantable Micro- drug delivery Microdevice (IMD)
- Keywords
- non small cell lung cancer, small cell lung cancer, mesothelioma, suspected lung cancer
- Medical subject headings
- Lung Neoplasms, Mesothelioma, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable Micro- drug delivery Microdevice (IMD)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Implantable Microdevice (IMD) + Standard-of-care Surgical Retrieval + Standard-of-Care Treatment | Experimental | 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. Receives: Drug: Implantable Micro- drug delivery Microdevice (IMD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 30 days
Secondary outcomes (1)
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.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start30 Oct 2026 (estimated)
- Primary completion30 Oct 2030 (estimated)
- Study completion30 Oct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oliver Jonas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Oliver Jonas, Brigham and Women's Hospital
- Investigators
- Raphael Bueno, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07892300
- Sponsor's protocol ID
- 26-320
- Status last verified
- Oct 2026
- First submitted
- 17 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.