Phase 1 Trial of Endobronchial Ultrasound-Guided Transbronchial Needle Injection of Cisplatin for Stage IV Lung Cancer

The goal of the study is to identify the maximum tolerated dose of endobronchial ultrasound-guided transbronchial injection (EBUS-TBNI) of cisplatin for Stage IV lung cancer.

Study Overview

• Status: Active, not recruiting
• Conditions: Lung Cancer Metastatic
• Intervention / Treatment: Drug: cisplatin

Detailed Description

Multiple studies have demonstrated feasibility and safety of delivering cisplatin directly into lung tumors using endobronchial ultrasound guided-transbronchial needle injection (EBUS-TBNI). This technique relies on the use of a bronchoscope with an integrated ultrasound transducer allowing real-time visualization of, and delivery of cisplatin into, tumors lying in proximity to the central airways. Prior work has utilized this technique to treat loco regional recurrence in a previously radiated field. The goal of the current study is to identify the initial dose for intratumoral cisplatin. Phase 1A is a dose ranging study. Phase 1B is designed to evaluate the safety of delivery of the drug into different tumor regions .

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Vermont
    • Burlington, Vermont, United States, 05405
      • University of Vermont

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

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 These may be primary lung cancers or metastatic sites (including when a lymph node station has been replaced by metastatic tumor), that are accessible by EBUS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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Initial Treatment- Low Perfusion Region; Phase 1B uses a within group comparison. All participants will undergo 1 delivery of intratumoral cisplatin into either a low or high perfusion region, then the subsequent week undergo delivery into the other region, for a total of 3 treatments.	Drug: cisplatin; Intratumoral delivery of cisplatin via bronchoscopy (endobronchial ultrasound); Other Names: Platinol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Dose limiting toxicity	14 days

Collaborators and Investigators

• Sponsor: University of Vermont
• Collaborators: University of Vermont Medical Center
• Investigators: Principal Investigator: C. Matthew Kinsey, MD, MPH, University of Vermont

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: March 14, 2020
• First Submitted That Met QC Criteria: March 14, 2020
• First Posted (Actual): March 17, 2020

Study Record Updates

• Last Update Posted (Estimated): October 31, 2025
• Last Update Submitted That Met QC Criteria: October 29, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Platinum Compounds; Cisplatin
• Other Study ID Numbers: 00000613

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No