Clinical trial · Interventional
Phase 1B Trial of Intratumoral Cisplatin for Stage IV Lung Cancer
- 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 addition of intravenous (given through a vein) cisplatin to immunotherapy improves treatment outcomes for lung cancer, but unfortunately results in significantly more side effects since the rest of the body is exposed to significant amounts of the drug. Our clinical trial data indicate that injecting cisplatin directly into the tumor using a bronchoscope (a small flexible tube with a camera in it) has very few side effects, and results in significant cell death and potentially improvement in the immune response. The goal of this proposal is to evaluate a computational approach, that incorporates data from a CT scan, to determine the optimal dose and delivery location within a tumor to maximize tumor cell killing and the immune response.
Conditions
Conditions (2)
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 | — |
| Lung Cancer (NSCLC) | Malignant Lung Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin (cis-diamminedichloroplatinum(II) (CDDP)) | Drug | Cisplatin | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Initial Dose Cohort: 95% Tumor Coverage
- description
- Intratumoral cisplatin dosed to cover 95% of the tumor
- interventionNames
- Drug: cisplatin (cis-diamminedichloroplatinum(II) (CDDP))
- type
- EXPERIMENTAL
- label
- De-escalation Dose Cohort: 90% Tumor Coverage
- description
- Intratumoral cisplatin dosed to cover 90% of the tumor
- interventionNames
- Drug: cisplatin (cis-diamminedichloroplatinum(II) (CDDP))
- type
- EXPERIMENTAL
- label
- Escalation Dose Cohort: 98% Tumor Coverage
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
2.5.1 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 * Patient is able and willing to provide informed consent. * Rapid on-site cytopathologic examination (ROSE) performed during the procedure (if not previously diagnosed) and returns likely NSCLC. No injection will be performed if ROSE is non-diagnostic. * A CT scan of the chest (with or without contrast) within the prior 3 months. * The presence of an EBUS accessible target site determined by a treating investigator. 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. * MDC agreement of likely Stage IV NSCLC (confirmation from at minimum a Medical Oncologist and Radiation Oncologist on clinical stage). * 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 * Creatinine ≤ institutional ULN 2.5.2 Exclusion criteria * Use of an investigational agent in prior 30 days * 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 UVMMC Policy NPREP16) * Treatment with intravenous cytotoxic chemotherapy within the past 14 days * Allergy to cisplatin or its derivatives * Allergy to iodinated contrast * Patient not appropriate for the research study based on physician discretion
References
Publications (0)
Data not yet available