Phase 1B Trial of Intratumoral Cisplatin for Stage IV Lung Cancer

NCT07495098 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 00000613B
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Lung Cancer Metastatic; Lung Cancer (NSCLC)

Outcome Measures

Primary Outcomes (1)

• Safety, as defined by dose limiting toxicity (DLT)

  Safety (dose limiting toxicity, DLT), as defined by CTCAE (Common Terminology Criteria for Adverse Events) v 6.0. CTCAE grade 3 or above will be considered a DLT.

  For 4 weeks after initial delivery of intratumoral cisplatin

Secondary Outcomes (1)

• Cisplatin retention

  At each delivery

Other Outcomes (1)

• Changes in the tumor microenvironment by dose

  At 1 week after each delviery of intratumoral cisplatin, by delivery region

Study Arms (3)

Initial Dose Cohort: 95% Tumor Coverage

EXPERIMENTAL

Intratumoral cisplatin dosed to cover 95% of the tumor

Drug: cisplatin (cis-diamminedichloroplatinum(II) (CDDP))

De-escalation Dose Cohort: 90% Tumor Coverage

EXPERIMENTAL

Intratumoral cisplatin dosed to cover 90% of the tumor

Drug: cisplatin (cis-diamminedichloroplatinum(II) (CDDP))

Escalation Dose Cohort: 98% Tumor Coverage

EXPERIMENTAL

Intratumoral cisplatin dosed to cover 98% of the tumor

Drug: cisplatin (cis-diamminedichloroplatinum(II) (CDDP))

Interventions

cisplatin (cis-diamminedichloroplatinum(II) (CDDP)) DRUG

The safety of intratumoral cisplatin will be evaluated by delivery region will be evaluated.

De-escalation Dose Cohort: 90% Tumor Coverage; Escalation Dose Cohort: 98% Tumor Coverage; Initial Dose Cohort: 95% Tumor Coverage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Vermont: lead

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Cisplatin

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

Kristi Chapman

CONTACT

8026567953; Kristina.Chapman@uvmhealth.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant is masked to dose level and delivery location
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Interventional Pulmonary

Model Details: The delivered dose will be calculated based on tumor volume and morphology to achieve 95% tumor coverage and will be ≤40mg. Dose escalation to 98% or dose de-escalation to 90% tumor coverage are alternative dose levels, maintaining total dose ≤40mg. We will use the standard 3+3 dose ranging protocol. Any patient who experiences a DLT will be removed from further treatments. If 1 of 3 patients experience a DLT we will continue at that dose level. If ≥33% of patients develop a dose-limiting toxicity at any time during the enrollment at a given dose cohort then the % goal tumor coverage for dose calculation will be reduced (e.g.to 90% tumor coverage).

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: March 27, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): June 30, 2031
• Last Updated: March 27, 2026

Record last verified: 2026-03