NCT04809103CompletedPhase 1
Intratumoral Cisplatin for Resectable NSCLC
A Phase 1 Trial of Intratumoral Cisplatin for Early Stage, Resectable, Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 6 Feb 2026
Brief summary (registry, in English)
PRIMARY OBJECTIVE: To identify the maximum tolerated dose (MTD) of intratumoral cisplatin, delivered during a single bronchoscopy with cone-beam CT confirmation, in a dose escalation protocol DESIGN: 3+3 dose escalation.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 6 (actual)
- First submitted
- 8 Mar 2021
- Start date
- 8 Mar 2021
- Primary completion date
- 1 Oct 2025
- Lead sponsor
- University of Vermont
- Diseases
- Lung cancer
- NCT number
- NCT04809103
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 6
- From 8 Mar 2021 to the primary completion date, 1 Oct 2025
- 1 site in 1 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.
Prior treatment
- Use of an investigational agent within 30 days of the screening visit
- IV chemotherapy within the 30 days of the screening visit
- History of prior radiation to the study lesion
Other illness
- History of allergic reaction to cisplatin or its derivatives
- Patients with uncontrolled intercurrent illness
Age
- 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 University of Vermont Medical Center Policy
Other
- Physician determination that patient would not be appropriate for study
Who the study is looking for
- Age ≥18 years.
- Eastern Cooperative Oncology Group performance status 0 or 1
- Patients must have adequate organ and marrow function as defined below:
- Leukocytes ≥3,000/microliter
- Platelets ≥100,000/microliter
- Total bilirubin ≤ institutional upper limit of normal (ULN)
- Aspartate aminotransferase /Alanine aminotransferase ≤3 × institutional upper limit of normal
- Creatinine ≤ institutional ULN
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
- Have known or suspected clinical stage I-IIb NSCLC after computed tomography (CT) and/or positron emission tomography at time of enrollment
- Presence of a target lesion with a minimum volume of 1.0 cm3, (approximately1.2 cm in diameter) and ≤ 5.0 cm in diameter
- Agreement from a cardiothoracic surgeon, following review of past medical history, medications, pulmonary function testing, and CT scan that patient is likely to be a surgical candidate and that, after considering known possible adverse events, delivery of intratumoral cisplatin is unlikely to adversely affect surgical feasibility
- Rapid on-site cytopathologic examination (ROSE) performed during the procedure returns likely NSCLC (per the determination of a trained, attending, cytopathologist). No research procedures will be performed if ROSE is non-diagnostic
- A CT scan of the chest (with or without contrast) within 1 month of the screening visit
- Ability to understand and the willingness to sign a written informed consent document
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Vermont Coordinator of this site? Confirm its status | Burlington | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.