Implantable Microdevices for in Situ Evaluation of Drug Responses in Lung Cancer

NCT07892300 | Not Yet Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: 26-320
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Lung Cancer; Mesothelioma; Suspected Lung Cancer; Suspected Mesothelioma

Keywords

non small cell lung cancer; small cell lung cancer; mesothelioma; suspected lung cancer

Outcome Measures

Primary Outcomes (1)

• 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

  up to 30 days

Secondary Outcomes (1)

• Feasibility of assessing tissue responses from microdevice treated tumor regions

  14 days

Study Arms (1)

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.

Drug: Implantable Micro- drug delivery Microdevice (IMD)

Interventions

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.

Implantable Microdevice (IMD) + Standard-of-care Surgical Retrieval + Standard-of-Care Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Oliver Jonas: lead

MeSH Terms

Conditions

Lung Neoplasms; Mesothelioma; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Mesothelial; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• Raphael Bueno, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raphael Bueno, MD

CONTACT

617-732-6824; rbueno@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 17, 2026
• First Posted: October 23, 2026
• Study Start (Estimated): October 30, 2026
• Primary Completion (Estimated): October 30, 2030
• Study Completion (Estimated): October 30, 2031
• Last Updated: October 23, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.