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

NCT ID: NCT04311762

Last Updated: 2025-10-31

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-01
• Study Completion Date: 2029-03-01

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.

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 .

Conditions

Lung Cancer Metastatic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

cisplatin

Intervention Type: DRUG

Intratumoral delivery of cisplatin via bronchoscopy (endobronchial ultrasound)

Interventions

cisplatin

Intratumoral delivery of cisplatin via bronchoscopy (endobronchial ultrasound)

Intervention Type: DRUG

Other Intervention Names

Platinol

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Vermont Medical Center

OTHER

Sponsor Role: collaborator

University of Vermont

OTHER

Sponsor Role: lead

Responsible Party

C. Matthew Kinsey MD, MPH

Director, Interventional Pulmonary

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

C. Matthew Kinsey, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Vermont

Locations

University of Vermont

Burlington, Vermont, United States

Countries

United States

Other Identifiers

00000613

Identifier Type: -

Identifier Source: org_study_id