NCT07495098Not yet recruitingPhase 1
Phase 1B Trial of Intratumoral Cisplatin for Stage IV Lung Cancer
Source: ClinicalTrials.gov · Last updated 27 Mar 2026
Brief summary (registry, in English)
The addition of intravenous (given through a vein) cisplatin to immunotherapy improves treatment outcomes for lung cancer, but unfortunately results in significantly more side effects since the rest of the body is exposed to significant amounts of the drug. Our clinical trial data indicate that injecting cisplatin directly into the tumor using a bronchoscope (a small flexible tube with a camera in it) has very few side effects, and results in significant cell death and potentially improvement in the immune response. The goal of this proposal is to evaluate a computational approach, that incorporates data from a CT scan, to determine the optimal dose and delivery location within a tumor to maximize tumor cell killing and the immune response.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 20 Mar 2026
- Start date
- 1 Jul 2026
- Primary completion date
- 1 Jul 2030
- Lead sponsor
- University of Vermont
- Diseases
- Lung cancer
- NCT number
- NCT07495098
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 12
- From 1 Jul 2026 to the primary completion date, 1 Jul 2030
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 2.5.1 Inclusion criteria
- Age 18 years or above
- Eastern Cooperative Oncology Group (ECOG) performance score 0-2
- Have known or suspected metastatic NSCLC at time of enrollment (including patients who progress on initial therapy or are found to have metastatic disease during therapy and are not excluded
- Patient is able and willing to provide informed consent.
- Rapid on-site cytopathologic examination (ROSE) performed during the procedure (if not previously diagnosed) and returns likely NSCLC. No injection will be performed if ROSE is non-diagnostic.
- A CT scan of the chest (with or without contrast) within the prior 3 months.
- The presence of an EBUS accessible target site determined by a treating investigator. These may be primary lung cancers or metastatic sites (including when a lymph node station has been replaced by metastatic tumor), that are accessible by EBUS.
- MDC agreement of likely Stage IV NSCLC (confirmation from at minimum a Medical Oncologist and Radiation Oncologist on clinical stage).
- Patients must have adequate organ and marrow function as defined below:
- Leukocytes ≥3,000/mcL
- Platelets ≥100,000/mcL
- Total bilirubin ≤ institutional upper limit of normal (ULN)
- AST(SGOT)/ALT(SGPT) ≤ institutional ULN
- Creatinine ≤ institutional ULN
- 2.5.2 Exclusion criteria
- Use of an investigational agent in prior 30 days
- Pregnancy/lactation (pregnancy test to be performed by pre-op as part of standard of care for women of child-bearing age as defined by UVMMC Policy NPREP16)
- Treatment with intravenous cytotoxic chemotherapy within the past 14 days
- Allergy to cisplatin or its derivatives
- Allergy to iodinated contrast
- Patient not appropriate for the research study based on physician discretion
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.