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

NCT04311762 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 00000613
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

• Dose limiting toxicity

  14 days

Study Arms (1)

Initial Treatment- Low Perfusion Region

EXPERIMENTAL

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

Interventions

cisplatin DRUG

Intratumoral delivery of cisplatin via bronchoscopy (endobronchial ultrasound)

Also known as: Platinol

Initial Treatment- Low Perfusion Region

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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 These may be primary lung cancers or metastatic sites (including when a lymph node station has been replaced by metastatic tumor), that are accessible by EBUS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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Vermont: lead
• University of Vermont Medical Center: collaborator

Study Sites (1)

University of Vermont

Burlington, Vermont, 05405, United States

Location

MeSH Terms

Interventions

Cisplatin

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• C. Matthew Kinsey, MD, MPH

  University of Vermont

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Interventional Pulmonary

Study Record Dates

• First Submitted: March 14, 2020
• First Posted: March 17, 2020
• Study Start: February 1, 2020
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: October 31, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)