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

NCT06879717 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-01-16

No results posted yet for this study

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

Conditions

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

Interventions

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

Sponsors & Collaborators

  • iOnctura

    lead INDUSTRY

Principal Investigators

  • Michael Lahn, MD · iOnctura

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-22
Primary Completion
2027-01-31
Completion
2028-01-31

Countries

  • Belgium
  • Italy
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06879717 on ClinicalTrials.gov