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-01).

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-517741-14-00

Acronym

IOA-244-202

Enrollment

Registered

2025-03-25

Start date

2025-04-22

Completion date

Unknown

Last updated

2026-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced non-squamous non-small cell lung cancer (NSCLC)

Brief summary

Change from baseline of at least 50% by Day 42 as assessed by mass cytometry (cytometry by time of flight, CyTOF).

Detailed description

AEs (graded by Common Terminology Criteria for Adverse Event [CTCAE] version 5.0), serum chemistry and haematology laboratory examinations, physical examinations., Change from baseline in immune related signatures as assessed by mass cytometry., Objective response rate (ORR), duration of response (DOR), Disease Control Rate (DCR), Clinical Benefit Rate (CBR) and progression free survival (PFS) per RECIST v1.1 as assessed by the investigator and overall survival (OS)., Plasma concentrations of roginolisib., AEs (graded by CTCAE version 5.0), serum chemistry and haematology laboratory examinations, physical examinations.

Interventions

DRUGIOA-244

DRUGDocetaxel 20 mg/ml concentrate for solution for infusion

DRUGJEMPERLI 500 mg concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change from baseline of at least 50% by Day 42 as assessed by mass cytometry (cytometry by time of flight, CyTOF).	—

Secondary

Measure	Time frame
AEs (graded by Common Terminology Criteria for Adverse Event [CTCAE] version 5.0), serum chemistry and haematology laboratory examinations, physical examinations., Change from baseline in immune related signatures as assessed by mass cytometry., Objective response rate (ORR), duration of response (DOR), Disease Control Rate (DCR), Clinical Benefit Rate (CBR) and progression free survival (PFS) per RECIST v1.1 as assessed by the investigator and overall survival (OS)., Plasma concentrations of roginolisib., AEs (graded by CTCAE version 5.0), serum chemistry and haematology laboratory examinations, physical examinations.	—

Measure

Time frame

—

Countries

Belgium, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026