Clinical trial · Interventional
Intratumoral Cisplatin for Resectable NSCLC
A Phase 1 Trial of Intratumoral Cisplatin for Early Stage, Resectable, Non-Small Cell Lung Cancer
NCT04809103CI-TRIAL-00102645completedPhase 1Results postedClinicalTrials.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)
PRIMARY OBJECTIVE: To identify the maximum tolerated dose (MTD) of intratumoral cisplatin, delivered during a single bronchoscopy with cone-beam CT confirmation, in a dose escalation protocol DESIGN: 3+3 dose escalation.
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 |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cis-diamminedichloroplatinum | Drug | Cisplatin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intratumoral Cisplatin 20 mg
- description
- Second dose level
- interventionNames
- Drug: cis-diamminedichloroplatinum
- type
- EXPERIMENTAL
- label
- Intratumoral Cisplatin 10 mg
- description
- First dose level
- interventionNames
- Drug: cis-diamminedichloroplatinum
Primary outcomes (1)
- measure
- Rate of Dose Limiting Toxicity
- timeFrame
- Within 2 weeks of delivery
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 years. * Eastern Cooperative Oncology Group performance status 0 or 1 * Patients must have adequate organ and marrow function as defined below: * Leukocytes ≥3,000/microliter * Platelets ≥100,000/microliter * Total bilirubin ≤ institutional upper limit of normal (ULN) * Aspartate aminotransferase /Alanine aminotransferase ≤3 × institutional upper limit of normal * Creatinine ≤ institutional ULN * 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 * Have known or suspected clinical stage I-IIb NSCLC after computed tomography (CT) and/or positron emission tomography at time of enrollment * Presence of a target lesion with a minimum volume of 1.0 cm3, (approximately1.2 cm in diameter) and ≤ 5.0 cm in diameter * Agreement from a cardiothoracic surgeon, following review of past medical history, medications, pulmonary function testing, and CT scan that patient is likely to be a surgical candidate and that, after considering known possible adverse events, delivery of intratumoral cisplatin is unlikely to adversely affect surgical feasibility * Rapid on-site cytopathologic examination (ROSE) performed during the procedure returns likely NSCLC (per the determination of a trained, attending, cytopathologist). No research procedures will be performed if ROSE is non-diagnostic * A CT scan of the chest (with or without contrast) within 1 month of the screening visit * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Use of an investigational agent within 30 days of the screening visit * IV chemotherapy within the 30 days of the screening visit * Pregnancy/lactation (pregnancy test to be performed by pre-op as part of standard of care for women of child-bearing age as defined by University of Vermont Medical Center Policy * History of prior radiation to the study lesion * History of allergic reaction to cisplatin or its derivatives * Patients with uncontrolled intercurrent illness * Physician determination that patient would not be appropriate for study
References
Publications (0)
Data not yet available
No reference posted for this study.