Phase 1 Trial of Endobronchial Ultrasound-Guided Transbronchial Needle Injection of Cisplatin for Stage IV Lung Cancer
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ClinicalTrials.gov Identifier: NCT04311762 |
Recruitment Status :
Recruiting
First Posted : March 17, 2020
Last Update Posted : March 19, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lung Cancer Metastatic | Drug: cisplatin | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 9 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase 1 Trial of Endobronchial Ultrasound-Guided Transbronchial Needle Injection of Cisplatin for Stage IV Lung Cancer |
Actual Study Start Date : | February 26, 2020 |
Estimated Primary Completion Date : | March 2022 |
Estimated Study Completion Date : | March 2022 |

- Drug: cisplatin
Intratumoral delivery of cisplatin via bronchoscopy (endobronchial ultrasound)Other Name: Platinol
- Dose limiting toxicity [ Time Frame: 14 days ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 based on 8.2 below).
Ability and willingness to provide informed consent
Rapid on-site cytopathologic examination (ROSE) performed during the procedure returns likely NSCLC (informed consent will occur prior to the procedure). No research procedures 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. These may be primary lung cancers or metastatic sites (including when a lymph node station has been replaced by metastatic tumor), that are accessible by EBUS
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
- Glomerular filtration rate (GFR) ≥60 mL/min/1.73 m2 via CKD EPI)
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
Exclusion Criteria:
Use of an investigational agent in prior 30 days
Pregnancy/lactation
Treatment with cytotoxic chemotherapy within the past 30 days
Prior (within the last 12 months) or ongoing radiation treatment to the study NSCLC
Allergy to cisplatin or its derivatives
Patient not appropriate for the research study based on physician discretion

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04311762
Contact: Stephanie Burns | (802) 656-8307 | stephanie.burns@uvmhealth.org |
United States, Vermont | |
University of Vermont | Recruiting |
Burlington, Vermont, United States, 05405 | |
Contact: Stephanie Burns 802-656-8307 stephanie.burns@uvmhealth.org |
Principal Investigator: | C. Matthew Kinsey, MD, MPH | University of Vermont |
Responsible Party: | C. Matthew Kinsey MD, MPH, Director, Interventional Pulmonary, University of Vermont |
ClinicalTrials.gov Identifier: | NCT04311762 |
Other Study ID Numbers: |
00000613 |
First Posted: | March 17, 2020 Key Record Dates |
Last Update Posted: | March 19, 2021 |
Last Verified: | March 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms |
Lung Diseases Respiratory Tract Diseases Cisplatin Antineoplastic Agents |