107TiP Dry powder inhaled cisplatin in stage IV NSCLC: The phase I/IIa CIS-DPI-01 study

CIS-DPI is a cisplatin-based dry powder for inhalation presenting an innovative approach for the treatment of patients with lung cancer. Thanks to its mode of administration (pulmonary route), CIS-DPI overcomes severe systemic toxicities observed with conventional iv chemotherapy and aims at increasing the efficacy of the current standard of care (SoC) treatment via (i) a daily local targeting of the tumour and (ii) a synergistic potential with immunotherapy, in particular through the immunogenic properties of CIS-DPI. This phase I/IIa study aims to investigate the safety, tolerability, pharmacokinetics and anti-tumour activity of ascending doses of CIS-DPI in combination with SoC treatment in adult patients with treatment-naïve stage IV NSCLC. Patients are enrolled into two populatons: Population 1 includes patients with PD-L1 tumour proportion score (TPS) ≥50%; Population 2 includes patients with PD-L1 TPS <50%. CIS-DPI is administered by inhalation, at home, 5 times weekly (5 days on followed by 2 days off) in addition to 4 cycles of SoC treatment (i.e., iv pembrolizumab for population 1, iv pembrolizumab and carboplatin-doublet chemotherapy for population 2). Each study population undergoes two phases. The first phase consists of a dose escalation (10 patients per population), aiming to determine the maximum tolerated dose and/or the recommended phase II dose (RP2D). The first set of patients will be treated for 14 weeks and undergo an adaptive intra-patient dose titration of CIS-DPI (maximum 3 different dose levels tested per patient) in combination with their SoC treatment. Once the RP2D is established, a safety expansion phase (6 patients per population) at the RP2D will be started, for collection of additional safety information. This set of patients will be treated for 12 weeks with CIS-DPI at the RP2D in combination with their SoC treatment. The first patient was enrolled on the October 16th 2023. EU trial number: 2022-501183-17-00. InhaTarget Therapeutics. InhaTarget Therapeutics.