NCT06879717

A Study of Roginolisib (IOA-244) in Combination With Dostarlimab With or Without Docetaxel in Metastatic Non Small-cell Lung Cancer (NSCLC) Patients

A Phase I/IIa Study of Roginolisib in Combination With Dostarlimab With or Without Docetaxel in Patients With Advanced Non-squamous NSCLC Who Have Progressed on Standard of Care Immune Checkpoint Therapy and Platinum Doublet Chemotherapy or Standard Immunotherapy Without Chemotherapy (PULMO-1)

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: iOnctura · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn how roginolisib works in combination with dostarlimab with or without docetaxel in adult patients with advanced non small-cell lung cancer. The main questions it aims to answer are: To compare across the treatment arms the proportion of patients with a reduction in Treg cells To evaluate the safety and tolerability of roginolisib plus dostarlimab, with or without docetaxel

Detailed description

A Phase I/IIa open-label, randomised study of oral roginolisib (IOA-244 \[roginolisib hemi-fumarate\]) in combination with dostarlimab with or without docetaxel in Advanced Non small-cell lung cancer (NSCLC) patients. This study will enrol approximately 45 male and female patients aged over 18 years with advanced NSLCL who have process on standard of care immune checkpoint therapy and platinum doublet chemotherapy or standard immunotherapy without chemotherapy. The disease must be measurable (i.e., at least 1 measurable lesion) as per RECIST v1.1 by Computerised Tomography (CT) scan or Magnetic Resonance Imaging (MRI).

Conditions

• Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
• Advanced Non Squamous NSCLC

Interventions

Type	Name	Description
DRUG	roginolisib	tablet, 40mg tablet strength
DRUG	Dostarlimab	500 mg administered as IV infusion
DRUG	Docetaxel	75 mg/m2 administered over 1 hour as IV infusion

Timeline

• Start date: 2025-04-22
• Primary completion: 2027-01-01
• Completion: 2028-01-01
• First posted: 2025-03-17
• Last updated: 2026-01-16

Locations

7 sites across 3 countries: Belgium, Italy, Spain