Trial intelligence / Profile preview

THIO Sequenced With Cemiplimab in Advanced NSCLC

NCT05208944Phase 2

Key facts

Status: Active, not recruiting
Start: Jun 2022
Primary completion: Sep 2027
Countries: 8
Sponsor: MAIA Biotechnology, Inc.
Modality: DNA Intercalators/Alkylators, Orthosteric Ligands, Metabolically Activated Prodrugs

Drugs: ateganosine
Conditions: non-small cell lung cancer (NSCLC)

Overview

Phase 2, randomised, open-label trial of ateganosine in non-small cell lung cancer (NSCLC) (4 arms), sponsored by MAIA Biotechnology, Inc. Primary endpoints: Safety and tolerability of THIO administered in sequence with cemiplimab up to 2 years and Efficacy of THIO administered in sequence with cemiplimab up to 2 years. Started Jun 2022; status: active, not recruiting.

Design

4 arms

Study design: RandomizedOpen-label

Part A: Safety Lead-in
THIO 360 mg or 180 mg per cycle + cemiplimab
Part B: Dose-finding
THIO 60 mg, 180 mg, or 360 mg per cycle + cemiplimab
Part C: Efficacy and Safety Comparison
THIO 180 mg + cemiplimab vs THIO 180 mg alone
Part D: Single-arm Efficacy
THIO 180 mg + cemiplimab

Who it enrols

Adults with advanced NSCLC who progressed or relapsed after prior anti-PD-1/PD-L1 therapy, with ECOG PS 0-1 and adequate organ function.

Endpoints

Primary

Safety and tolerability of THIO administered in sequence with cemiplimabUp to 2 years
Efficacy of THIO administered in sequence with cemiplimabUp to 2 years

Beyond the preview

Go deeper on NCT05208944.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT05208944.