Clinical trial · Interventional
Phase 1 Trial of Endobronchial Ultrasound-Guided Transbronchial Needle Injection of Cisplatin for Stage IV Lung Cancer
NCT04311762CI-TRIAL-00096908active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer Metastatic | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Initial Treatment- Low Perfusion Region
- description
- 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.
- interventionNames
- Drug: cisplatin
Primary outcomes (1)
- measure
- Dose limiting toxicity
- timeFrame
- 14 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 These may be primary lung cancers or metastatic sites (including when a lymph node station has been replaced by metastatic tumor), that are accessible by EBUS Patients must have adequate organ and marrow function as defined below: * Leukocytes ≥3,000/mcL * Platelets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
References
Publications (0)
Data not yet available
No reference posted for this study.