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Active Not RecruitingPhase 1NCT04311762
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedcisplatin

The study team can explain what participation involves.

Who it may be forMetastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 31, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Phase 1

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?University of Vermont

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
University of Vermont
Interventions being studied
Drug: cisplatin
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Disease setting
Metastatic or stage IV→
Treatment approach
Chemotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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 These may be primary lung cancers or metastatic sites (including when a lymph node station has been replaced by metastatic tumor), that are accessible by EBUS Patients must have adequate organ and marrow function as defined below: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
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of VermontBurlington, Vermont

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 31, 2025. Always confirm current availability with the study team.

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