Actively Recruiting
A Phase I/II Trial to Study Safety and Activity of Dry Powder Cisplatin Inhalation for Stage IV Non-Small Cell Lung Cancer
Led by Inhatarget Therapeutics · Updated on 2025-03-26
32
Participants Needed
15
Research Sites
N/A
Total Duration
On this page
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 patient's 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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks
Participants receive daily inhaled cisplatin treatment using a dry powder inhaler device for 5 days each week, followed by 2 days off, combined with standard of care intravenous therapy. This treatment is given to evaluate safety and activity in patients with Stage IV non-small cell lung cancer.
Daily treatment 5 days per week with regular study visits during treatment period
Duration - Up to 100 months
Participants are monitored for long-term effects, survival, and disease progression after completing the treatment phase.
Periodic visits for ongoing assessment of survival and disease progression
Trial Site Locations
Total: 15 locations
1
Institut Jules Bordet - Hôpital Universitaire de Bruxelles
Brussels, Belgium
Actively Recruiting
2
GHDC
Charleroi, Belgium
Actively Recruiting
3
CHU Helora - Site Jolimont
Jolimont, Belgium
Actively Recruiting
4
AZ Groeninge
Kortrijk, Belgium
Actively Recruiting
5
CHU Sart Tilman
Liège, Belgium
Actively Recruiting
6
CHU Ambroise Paré
Mons, Belgium
Actively Recruiting
7
AZ Delta
Roeselare, Belgium
Actively Recruiting
8
Université Paris-Saclay, UVSQ, APHP - Hôpital Ambroise Paré
Boulogne-Billancourt, France
Not Yet Recruiting
9
Centre François Baclesse de Caen
Caen, France
Not Yet Recruiting
10
Hôpital Européen Georges Pompidou, Paris-Cite University
Paris, France
Not Yet Recruiting
11
L'Institut de Cancérologie de l'Ouest
Saint-Herblain, France
Not Yet Recruiting
12
Instituto Oncologico Dr Rosell, Hospital Universitario Dexeus
Barcelona, Spain
Actively Recruiting
13
Hospital Universitario 12 de Octubre
Madrid, Spain
Actively Recruiting
14
Hospital Universitario La PAZ, IdiPAZ
Madrid, Spain
Actively Recruiting
15
Hospital Universitario Virgen del Rocío
Seville, Spain
Actively Recruiting
Research Team
F
Frédéric De Coninck
W
Wendy Sonnet, MSc, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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