A Phase III Study With THIO + Cemiplimab vs Chemotherapy as 3rd Line Treatment in Advanced/Metastatic NSCLC

THIO is a first-in-class small molecule telomere targeting agent, in development for the treatment of non-small cell lung cancer (NSCLC) in combination with cemiplimab (LIBTAYO®). THIO is preferentially incorporated into telomeres sequence in telomerase-positive cells leading to rapid telomere uncapping, genomic instability, and cell death. Cemiplimab is a programmed cell death protein 1 (PD-1) inhibitor recently approved as a first-line treatment for patients with locally advanced or metastatic NSCLC with 50% or more PD-L1 expression. It is hypothesized that THIO administration prior to cemi

Trial Details

NCT ID

NCT06908304

Phase

PHASE3

Sponsor

Maia Biotechnology

Status

RECRUITING

Cancer Type

Adenocarcinoma Lung Cancer

Interventions

6-Thio-2'-Deoxyguanosine
Cemiplimab
Docetaxel
Vinorelbine
Gemcitabine alone

Locations (sample)

Poznan, Poland|52.40692,16.92993
Craiova, Romania|44.31667,23.8
Timișoara, Romania|45.75372,21.22571
Changhua, Taiwan|24.0692,120.5512
Chiayi City, Taiwan|23.47917,120.44889

Key Eligibility Criteria

At least 18 years of age at the time of signing the Informed Consent Form (ICF) prior to initiation of any study specific activities/procedures.
Disease Characteristics
Stage 3b or 4 histologically or cytologically confirmed NSCLC. Note: Stage is determined at the time of diagnosis.
Two (2) prior lines of systemic treatment for advanced/metastatic disease, including an ICI (anti-PD-1/PD-L1) and a platinum-based chemotherapy (gi…

For full eligibility, visit ClinicalTrials.gov.

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