RecruitingPhase 3NCT06908304

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

Sponsor

Maia Biotechnology

Enrollment

300 participants

Start Date

Dec 8, 2025

Study Type

INTERVENTIONAL

Conditions

Carcinoma, Non-Small Cell Lung

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug combination — THIO plus cemiplimab (an immunotherapy) — against standard chemotherapy as a third-line treatment for people with advanced or metastatic non-small cell lung cancer who have already tried two prior treatments. **You may be eligible if...** - You are 18 or older - You have stage 3b or stage 4 non-small cell lung cancer confirmed by biopsy - You have already received two lines of treatment, including an immunotherapy (anti-PD-1/PD-L1) and platinum-based chemotherapy - Your cancer has progressed or you could not tolerate your last treatment - You are in good overall health **You may NOT be eligible if...** - You have not completed two prior lines of treatment - Your cancer has certain genetic mutations that have effective targeted therapies available - Your organ function or overall health is too poor Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG6-Thio-2'-Deoxyguanosine

small molecule telomere targeting agent

DRUGCemiplimab

programmed cell death protein 1 (PD-1) inhibitor

DRUGDocetaxel

Chemotherapy drug; inhibits cell division by stabilizing microtubules. Used for breast, lung, and prostate cancers.

DRUGVinorelbine

Chemotherapy drug; disrupts microtubule formation, inhibiting cell division. Used for non-small cell lung cancer and breast cancer.

DRUGGemcitabine alone

Chemotherapy drug; inhibits DNA synthesis. Used for pancreatic, lung, breast, and ovarian cancers.

Locations(15)

Centrum Medyczne Pratia

Poznan, Poland

Oncolab S.R.L.

Craiova, Romania

Spitalul Clinic Municipal de Urgenta Timisoara/ Clinica de Oncologie Medicala

Timișoara, Romania

Changhua Christian Hospital (CCH)

Changhua, Taiwan

Taipei Tzu Chi Hospital

Chiayi City, Taiwan

Chang-Gung Memorial Hospital - KaoHsiung

Kaohsiung City, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)

Kaohsiung City, Taiwan

Chung Shan Medical University Hospital (CSMUH)

Taichung, Taiwan

Taipei Medical University Hospital (TMUH)

Taipei, Taiwan

Tri-Service General Hospital

Taipei, Taiwan

Chang-Gung Memorial Hospital - Linko

Taoyuan City, Taiwan

Medicalpark Hastanesi

Adana, Turkey (Türkiye)

Liv Hospital

Ankara, Turkey (Türkiye)

Göztepe Süleyman Yalçın Şehir Hastanesi

Istanbul, Turkey (Türkiye)

İstinye University

Istanbul, Turkey (Türkiye)

View Full Details on ClinicalTrials.gov

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NCT06908304

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