Cisplatin for Lung Cancer

Overseen By Stephanie Burns

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Vermont

Must not be taking: Cytotoxic chemotherapy

Disqualifiers: Pregnancy, Radiation, Allergy to cisplatin, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safe dosage of the chemotherapy drug cisplatin for treating Stage IV lung cancer. A special technique delivers the drug directly to the lung area affected by cancer. Suitable candidates have Stage IV lung cancer that has spread or recurred after initial treatment. Participants must be able to undergo a CT scan and have a specific lung area that can be targeted for treatment. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to contribute to groundbreaking research.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop your current medications. However, you cannot have used an investigational agent or received cytotoxic chemotherapy in the past 30 days.

What prior data suggests that this method is safe for humans?

Research has shown that cisplatin is generally safe for patients with lung cancer. Studies have found that cisplatin is often the first treatment choice for lung cancer, indicating a good safety record. In one study, patients taking cisplatin experienced side effects like nausea and low blood counts, but standard medical care managed these effects. Another study found that cisplatin-based chemotherapy improved survival rates for lung cancer patients, highlighting its positive risk-to-benefit balance. Although this trial is still in the early stages, existing data on cisplatin strongly supports its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about using cisplatin with endobronchial ultrasound-guided transbronchial needle injection for lung cancer because it offers a targeted delivery method. Unlike traditional chemotherapy, which is systemic and affects the entire body, this approach allows for the direct injection of cisplatin into lung tumors. This targeted delivery could potentially increase the drug's effectiveness at the tumor site while reducing harmful side effects on the rest of the body. Additionally, it allows for precise delivery to different tumor regions, possibly enhancing the treatment's ability to tackle cancer cells in areas with varying blood flow.

What evidence suggests that this treatment might be an effective treatment for lung cancer?

Research shows that cisplatin commonly treats various cancers, including lung cancer. Studies have found that chemotherapy with cisplatin can extend the lives of patients with non-small-cell lung cancer. In some cases, cisplatin successfully controls tumor growth. However, while very effective, it doesn't always extend life when used alone. The treatment damages the DNA of cancer cells, slowing or stopping their growth. Participants in this trial will receive intratumoral cisplatin delivered into different perfusion regions to evaluate its effectiveness. ^{5 6 7 8 9}

Who Is on the Research Team?

C. Matthew Kinsey, MD, MPH

Principal Investigator

University of Vermont

Are You a Good Fit for This Trial?

This trial is for adults with Stage IV lung cancer who can perform daily activities with minimal assistance (ECOG score 0-2). They must have suspected or confirmed metastatic NSCLC, be able to consent, and have a recent CT scan. Eligible patients should also have normal blood counts and bilirubin levels, and an EBUS accessible tumor.

Inclusion Criteria

Ability and willingness to provide informed consent

A CT scan of the chest (with or without contrast) within the prior 3 months.

Leukocytes ≥3,000/mcL

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1A - Dose Ranging

Participants receive varying doses of intratumoral cisplatin to identify the initial dose

4 weeks

1 visit (in-person) per week

Phase 1B - Safety Evaluation

Participants receive intratumoral cisplatin in different tumor regions to evaluate safety

3 weeks

1 visit (in-person) per week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cisplatin
• Endobronchial Ultrasound-Guided Transbronchial Needle Injection

Trial Overview The study aims to find the highest dose of cisplatin that can be safely injected directly into lung tumors using endobronchial ultrasound guidance without causing severe side effects in patients with advanced lung cancer.

How Is the Trial Designed?

Group I: Initial Treatment- Low Perfusion Region Experimental Treatment 1 Intervention

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.

Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Approved in United States as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Approved in Canada as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Approved in Japan as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Who Is Running the Clinical Trial?

University of Vermont

Lead Sponsor

Trials

283

Recruited

3,747,000+

University of Vermont Medical Center

Collaborator

Trials

46

Recruited

25,900+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4146684/

Cisplatin in cancer therapy: molecular mechanisms of action It has been used for treatment of numerous human cancers including bladder, head and neck, lung, ovarian, and testicular cancers.

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa031644

Cisplatin-Based Adjuvant Chemotherapy in Patients with ... This large trial showed that cisplatin-based chemotherapy improves survival among patients who have undergone complete resection of non–small-cell lung cancer.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/16080557/

Phase II study of cisplatin-combined schedules as second- ... The cisplatin combination as second-line treatment in patients with NSCLC exhibited a notable degree of activity and tumor growth control was evidenced by ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0014482721002093

CD47 blockade enhances therapeutic efficacy of cisplatin ... The present study aims to explore the effects of CDDP on lung carcinoma and its relationship with macrophage phagocytosis.

5. mdpi.com mdpi.com/1422-0067/26/16/7958

Research Progress of Platinum-Based Complexes in Lung ... Although Cisplatin has higher therapeutic activity and demonstrates a higher ORR, it does not show a change in survival advantage [4,8]. Therefore, from a ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6940240/

Safety outcomes in advanced non-small-cell lung cancer ... We analyzed the treatment patterns and safety outcomes of the most common first-line platinum-based regimens initiated on or after non-small cell lung cancer ( ...

7. annalsofoncology.org annalsofoncology.org/article/S0923-7534(20)38541-0/fulltext

Safety data from randomized phase II study of cisplatin (CDDP) ... The primary endpoint was 2-year progression-free survival (PFS) rate. The sample size was set at 100 patients. Results: Between Jan 2013 and Oct 2016, 102 ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0959804925006288

Survival outcomes with carboplatin versus cisplatin and the ... Guidelines recommend cisplatin as the preferred platinum agent in the first-line treatment for small cell lung cancer (SCLC), ...

9. link.springer.com link.springer.com/article/10.1007/s00595-025-03019-9

Safety and efficacy of neoadjuvant cisplatin + S-1 ... The 5 year recurrence-free survival (RFS) rate was 76.4%, and the 3- and 5 year overall survival (OS) rates were 86.2% and 82.3%, respectively.