Clinical Trial

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

Study acronym: PULMO-01
Active, Not Recruiting Phase 1/2
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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
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-03-14; most recent amendment 2026-01-15.
Status change: Recruiting → Active, Not Recruiting 2026-01-15
Status change: Not Yet Recruiting → Recruiting 2025-04-30
Trial Details
NCT Number NCT06879717
Lead Sponsor iOnctura
Conditions Non-Squamous Non-Small Cell Lung Cancer (NSCLC), Advanced Non Squamous NSCLC
Enrollment 45 participants
Start Date 2025-04-22
Primary Completion 2027-01 (estimated)
Study Completion 2028-01 (estimated)
Updated on ClinicalTrials.gov 2026-01-16