What is cisplatin inhalation studying for advanced non-small cell lung cancer?

This trial is studying cisplatin delivered by inhalation using a dry powder inhaler to treat stage IV non-small cell lung cancer. Researchers want to see if this method can safely increase local chemotherapy doses and improve treatment outcomes when combined with standard immunotherapy and chemotherapy. The study is sponsored by Inhatarget Therapeutics and explores a new way to deliver chemotherapy at home.

Who may be eligible for this non-small cell lung cancer clinical trial?

Adults 18 years or older with confirmed stage IV NSCLC who have not received prior treatment for this stage may be eligible. Participants must have measurable disease and be able to use a dry powder inhaler device. They also need adequate organ function and lung capacity. Please review eligibility criteria for more details.

Is there any cost to participate in this non-small cell lung cancer clinical trial?

Study-related care, including the inhaled cisplatin treatment and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for visits and treatments.

Actively Recruiting

Phase 1

Phase 2

Age: 18Years +

All Genders

ID06896890

Study of Inhaled Cisplatin Dry Powder Combined With Standard Treatment for Stage IV Non-Small Cell Lung Cancer

Led by Inhatarget Therapeutics · Updated on 2025-03-26

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating a new way to treat patients with stage IV non-small cell lung cancer NSCLC by combining chemotherapy and immunotherapy. This approach aims to improve overall survival and progression-free survival, which are important measures of treatment success. The study focuses on delivering cisplatin chemotherapy through a dry powder inhaler, which may reduce the severe side effects seen with traditional chemotherapy and allow for more frequent treatment at home. This inhaled method might provide a safer and potentially effective option alongside standard treatments like pembrolizumab and carboplatin-based chemotherapy. Participants will receive cisplatin administered via a single-use dry powder inhaler device in doses ranging from 2.5 mg to a maximum of 30 mg daily, five days a week with two days off. This inhaled cisplatin will be combined with standard care treatments, including intravenous pembrolizumab alone or with carboplatin-doublet chemotherapy depending on the patients tumor type. The study includes a dose escalation phase to find the maximum tolerated dose, followed by a safety expansion phase to recommend a dose for further study. During the 12-week treatment period, participants will be closely monitored for safety, tolerability, and anti-tumor activity through various tests and assessments. Researchers will measure outcomes such as the maximum tolerated dose, recommended phase II dose, objective response rate, disease control, duration of response, overall survival, and progression-free survival, with some measures followed up to 100 months. Participants will also undergo regular laboratory tests, imaging, and evaluations of lung function and oxygen levels, with an emphasis on safely managing treatment and assessing the potential benefits of inhaled chemotherapy.

CONDITIONS

Brief Title

Cisplatin (CIS) Administered As Dry Powder for Inhalation (DPI) in Patients with Stage IV Non-Small Cell Lung Cancer

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Age 18 years or older at time of informed consent
Confirmed Stage IV non-small cell lung cancer suitable for pembrolizumab alone or combined with carboplatin/pemetrexed or paclitaxel
Measurable disease according to RECIST 1.1
Treatment-naive for stage IV NSCLC at study enrollment; prior platinum-based adjuvant treatment allowed if completed at least 6 months before
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate organ function including blood counts, kidney function, liver enzymes, and coagulation parameters
Resting oxygen saturation of at least 90%, forced expiratory volume (FEV1) ≥50%, and diffusing capacity of the lung for carbon monoxide (DLCO) ≥50%
Ability to properly use the single-dose dry powder inhaler device
Women of childbearing potential must have negative pregnancy test and not be pregnant or breastfeeding
Agreement to use effective contraception during study and for 6 months after last dose
Willingness and ability to comply with study visits, treatment, and procedures

You will not qualify if you...

Contraindication or unwillingness to undergo contrast-enhanced CT scans and chest X-rays as per protocol
Participation in another investigational drug or device study within 4 weeks prior to first treatment
Treatment with any anti-cancer agent within 6 months prior to first treatment
Prior therapy with immune checkpoint inhibitors
Prior radiotherapy to head, neck, thorax, or abdomen within 4 weeks prior to first treatment (except palliative radiotherapy)
Concurrent thoracic irradiation for lung cancer
Major surgery within 4 weeks prior to first treatment
Presence of EGFR activating mutation, ALK translocation, or other actionable molecular alterations eligible for targeted therapy
Non-smokers without EGFR and ALK test results before first treatment
Pre-existing hearing impairment due to VIII nerve damage
History of severe intolerance or sensitivity to cisplatin, vitamin E, or lactose
Mouth abnormalities preventing proper inhaler use
Uncontrolled symptomatic pleural effusion or pneumothorax
Prior pneumonectomy or bilobectomy excluding right middle lobe
History of severe cough or bronchospasm with dry powder inhalers
Chronic respiratory conditions other than controlled asthma or rhinitis
Recent or active interstitial lung disease, pneumonitis, or severe COPD exacerbation
Uncontrolled asthma as defined by guidelines
Uncontrolled or severe active infection
Positive HIV or active hepatitis B or C infection
Positive COVID-19 PCR within 72 hours before first treatment
Live virus vaccination within 30 days before first treatment
Use of oral corticosteroids above defined doses within 4 weeks prior to first treatment
Persistent toxicities ≥ grade 2 from previous cancer therapy (except alopecia)
Active malignancy other than certain treated cancers or cancer-free for at least 3 years
Recent thromboembolic events within 3 months prior to first treatment
Significant cardiac conditions or uncontrolled hypertension
History of organ transplant or ongoing immunosuppressive therapy
CNS pathology, autoimmune disease, significant coagulation disorder
Carcinomatous meningitis or CNS metastases unless stable and irradiated
Peripheral neuropathy greater than grade 1
Any medical condition that would make participation unsafe or not in patient's best interests
Inability or unwillingness to comply with study protocol for any reason

Research Team

Frédéric De Coninck

Wendy Sonnet, MSc, PhD

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Study of Inhaled Cisplatin Dry Powder Combined With Standard Treatment for Stage IV Non-Small Cell Lung Cancer

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria