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

Korábbi kezelés

• Use of an investigational agent in prior 30 days
• Treatment with cytotoxic chemotherapy within the past 30 days
• Prior (within the last 12 months) or ongoing radiation treatment to the study NSCLC

Más betegség

• Allergy to cisplatin or its derivatives

Egyéb

• Pregnancy/lactation
• Patient not appropriate for the research study based on physician discretion

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 These may be primary lung cancers or metastatic sites (including when a lymph node station has been replaced by metastatic tumor), that are accessible by EBUS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