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A Multicenter, Open-label, Randomized Phase 3 Study Evaluating THIO Sequenced with Cemiplimab (LIBTAYO®) vs Investigator Choice of Single-agent Chemotherapy as Third-line Treatment in Subjects with Advanced / Metastatic Non-Small Cell Lung Cancer (NSCLC)

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-520164-33-00
Acronym
THIO-104
Enrollment
80
Registered
2025-09-18
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-19

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

Conditions

Non-Small Cell Lung Cancer

Brief summary

OS (defined as the time from randomization to death from any cause)

Detailed description

ORR (defined as the proportion of subjects demonstrating a confirmed objective response of CR or PR), DCR (defined as the proportion of subjects demonstrating CR, PR, or SD after 2 treatment cycles), DoR (defined as the time from response [CR/PR] to PD), PFS (defined as the time from randomization to the first occurrence of PD or death from any cause, whichever occurs first), Incidence of TEAEs, SAEs, and TEAEs leading to discontinuation of study medication (THIO and/or cemiplimab) and/or withdrawal from the study

Interventions

DRUGLIBTAYO 350 mg concentrate for solution for infusion.
DRUGGemcitabine 1 g Powder for Solution for Infusion
DRUGVinorelbine 10 mg/ml concentrate for solution for infusion
DRUGTHIO
DRUGTAXOTERE 20 mg/0.5 ml concentrate and solvent for solution for infusion

Sponsors

Maia Biotechnology Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
OS (defined as the time from randomization to death from any cause)—

Secondary

MeasureTime frame
ORR (defined as the proportion of subjects demonstrating a confirmed objective response of CR or PR), DCR (defined as the proportion of subjects demonstrating CR, PR, or SD after 2 treatment cycles), DoR (defined as the time from response [CR/PR] to PD), PFS (defined as the time from randomization to the first occurrence of PD or death from any cause, whichever occurs first), Incidence of TEAEs, SAEs, and TEAEs leading to discontinuation of study medication (THIO and/or cemiplimab) and/or withdrawal from the study—

Countries

Hungary, Poland, Romania

Outcome results

None listed

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