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ACTIVE_NOT_RECRUITINGPHASE1

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

NCT04311762•University of Vermont

Summary

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.

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 .

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 These may be primary lung cancers or metastatic sites (including when a lymph node station has been replaced by metastatic tumor), that are accessible by EBUS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)
+3 more criteria

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

Locations (1)

University of Vermont

Burlington, Vermont, United States

Key Dates

Start Date

February 1, 2020

Primary Completion Date

March 1, 2029

Completion Date

March 1, 2029

Last Updated

October 31, 2025

Enrollment

ESTIMATED participants

Conditions

Lung Cancer Metastatic

Interventions

cisplatin

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RECRUITINGPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 31, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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