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

NCT06908304 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-01-12

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Maia Biotechnology

    lead INDUSTRY

Principal Investigators

  • Victor Zaporojan, Medical Doctor · MAIA Biotechnology Senior Medical Director

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-08
Primary Completion
2027-07-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • Poland
  • Romania
  • Taiwan
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06908304 on ClinicalTrials.gov