Cisplatin (CIS) Administered As Dry Powder for Inhalation (DPI) in Patients with Stage IV Non-Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInhatarget Therapeutics
About this trial
The combination of chemotherapy and immunotherapy shows promising results in terms of overall survival (OS) and progression-free survival (PFS) for the treatment of first-line stage IV non-small cell lung cancer (NSCLC) patients, leading to such combinations becoming a real backbone of the Standard of Care (SoC) for NSCLC patients.
However, conventional chemotherapy's severe systemic toxicities represent a limiting factor in terms of administered dose and frequency. Administration of cisplatin by inhalation (pulmonary route) is a promising additional approach that may overcome the limitations of conventional chemotherapy.
Use of a dry powder inhaler enables a high therapeutic response by delivering high local concentrations of a well-established active substance without the usual undesired reactions that limit the use of high doses when administered through the conventional systemic route.
This study may provide insights into whether this add-on treatment might be a safe and potentially efficacious option for NSCLC patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The patient must be ≥18 years of age at the time of signing the informed concent form (ICF).
The patient must have a pathologically or cytologically confirmed Stage IV NSCLC that could be treated with pembrolizumab alone or combined with carboplatin/pemetrexed or paclitaxel.
The patient must have measurable disease according to RECIST 1.1.
The patient must be treatment naïve for stage IV NSCLC at the time of study enrolment. Patients having received, at least 6 months before D1, platinum derivatives adjuvant after (i) surgery or (ii) concomitant chemotherapy-radiotherapy for unresectable locally advanced NSCLC are eligible.
Disqualifiers
Patients with contraindication to or unwillingness to undergo contrast-enhanced computed tomography (CT) scans and chest X-rays according to the protocol requirements.
Patients who are participating in an investigational drug or device study within 4 weeks prior to the planned day for the first study treatment administration (D1).
Patients who have been treated by any anti-neoplastic agent within 6 months prior to the planned day for the first study treatment administration (D1).
Patients who have received prior therapy with an immune checkpoint inhibitor.
Trial design
Design model
Single group
Treatments tested in this trial
CIS-DPI
Drug* Administration of cisplatin by inhalation (pulmonary route) using single-use RS01 capsule-based device and CIS-DPI hard capsules containing 2.5 mg, 5 mg, and 10 mg cisplatin. * CIS-DPI, administered once-a-day, 5-days on followed by 2-days off. Daily dose to be administered will range from an initial dose of 2.5 mg cisplatin to a maximal theoretical dose of 30 mg (i.e., dose 1 to dose 7).
Treatment groups
32 Participants
are divided into 1 treatment groupGroup A: Cisplatin Dry Powder for Inhalation (CIS-DPI)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Maximum Tolerated Dose (dose escalation phase)
Define the Maximum Tolerated Dose (MTD) based on Dose Limiting Toxicity (DLT). Dose-Limiting toxicity is defined to be a toxicity (i.e. confirmed investigational product related AE) that prevents further administration of the agent at that dose level.
Time frame
From first study treatment administration (Day 1) to the end of Week 12.2
Recommended Phase II dose (Safety expansion phase)
Confirm the recommended phase II dose (RP2D) based on Dose Limiting Toxicity (DLT). Dose-Limiting toxicity is defined to be a toxicity (i.e. confirmed investigational product related AE) that prevents further administration of the agent at that dose level.
Time frame
From the first study treatment administration (Day 1) to the end of Week 12.Secondary outcomes
1
Pharmacodynamic markers
To assess platinum plasma levels
Time frame
From first study treatment administration (Day 1) to the end of Week 12.2
CIS-DPI efficacy - Objective response rate (ORR)
To assess the incidence of objective response (OR), stable disease (SD), progressive disease (DP) at each tumour response assessment planned according to the Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) and Immune Response Evaluation Criteria in Solid Tumours (iRECIST);
Time frame
From first study treatment administration (Day 1) to the end of Week 12.3
CIS-DPI efficacy - DCR
To assess the disease control rate (DCR)
Time frame
From first study treatment administration (Day 1) to the end of Week 12.4
CIS-DPI efficacy - BOR
To assess the best overall response (BOR);
Time frame
From first study treatment administration (Day 1) to the end of Week 12.Other outcomes
1
CIS-DPI induced Immune Reactions
To assess cytokine levels.
Time frame
From first study treatment administration (Day 1) to the end of Week 12.2
CIS-DPI induced Immune Reactions
To assess immune cell count.
Time frame
From first study treatment administration (Day 1) to the end of Week 12.3
CIS-DPI efficacy - RECIST 1.1 Tumor burden
To assess tumour burden evolution using RECIST 1.1 analyses
Time frame
From first study treatment administration (Day 1) to the end of Week 12.4
CIS-DPI efficacy - iRECIST Tumor burden
To assess tumour burden evolution using iRECIST analyses
Time frame
From first study treatment administration (Day 1) to the end of Week 12.Sponsors and contacts
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Source ClinicalTrials.gov