NCT06908304

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

A Multicenter, Open-label, Randomized Phase 3 Study of THIO Sequenced With Cemiplimab (LIBTAYO®) vs Investigator's Choice of Chemotherapy as Third-line Treatment in Advanced/Metastatic NSCLC

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Maia Biotechnology · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 cemiplimab would restore tumor responses to immunotherapy in subjects who either developed resistance or relapsed after receiving first line treatment with an immune check point inhibitor.

Conditions

• Carcinoma, Non-Small -Cell Lung

Interventions

Type	Name	Description
DRUG	6-Thio-2'-Deoxyguanosine	small molecule telomere targeting agent
DRUG	Cemiplimab	programmed cell death protein 1 (PD-1) inhibitor
DRUG	Docetaxel	Chemotherapy drug; inhibits cell division by stabilizing microtubules. Used for breast, lung, and prostate cancers.
DRUG	Vinorelbine	Chemotherapy drug; disrupts microtubule formation, inhibiting cell division. Used for non-small cell lung cancer and breast cancer.
DRUG	Gemcitabine alone	Chemotherapy drug; inhibits DNA synthesis. Used for pancreatic, lung, breast, and ovarian cancers.

Timeline

• Start date: 2025-12-08
• Primary completion: 2027-07-31
• Completion: 2027-12-31
• First posted: 2025-04-03
• Last updated: 2026-01-12

Locations

15 sites across 4 countries: Poland, Romania, Taiwan, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study