Actively Recruiting
A Phase III Study With THIO + Cemiplimab vs Chemotherapy as 3rd Line Treatment in Advanced/Metastatic NSCLC
Led by Maia Biotechnology · Updated on 2026-01-12
300
Participants Needed
15
Research Sites
107 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Phase III Study With THIO + Cemiplimab vs Chemotherapy as 3rd Line Treatment in Advanced/Metastatic NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old at informed consent
- Histologically or cytologically confirmed stage 3b or 4 non-small cell lung cancer
- Have received two prior systemic treatments for advanced/metastatic disease including an immune checkpoint inhibitor and platinum-based chemotherapy
- Documented progression or intolerance after most recent therapy
- Documented secondary resistance to prior immune checkpoint inhibitor treatment
- No prior targeted therapy for driver mutations
- At least one measurable target lesion per RECIST v1.1 with progression after latest therapy
- Archival tissue sample available if possible
- ECOG performance status of 0-1
- Adequate bone marrow, liver, and renal function per protocol definitions
- Women of childbearing potential must have negative pregnancy test before treatment
- Use of effective contraception during and for six months after treatment if applicable
- Able and willing to provide signed informed consent
You will not qualify if you...
- Primary resistance to prior checkpoint inhibitor therapy
- Untreated or symptomatic central nervous system metastases
- Recent chemotherapy, targeted therapy, immunotherapy, or radiation within specified washout periods
- Prior treatment with cemiplimab
- Prior targeted therapy for EGFR mutation
- Blood transfusion within 14 days prior to treatment
- Live, inactivated, or research vaccines within 30 days prior to treatment (seasonal flu vaccine allowed)
- Prior allogeneic hematopoietic stem cell or solid organ transplant
- Major surgery within 28 days before treatment
- Not recovered from prior treatment adverse events to Grade 1 or better
- Ongoing or permanent immune-related adverse events requiring discontinuation
- Active gastrointestinal bleeding
- History of other concurrent malignancies unless in remission for 3 years
- Need for systemic corticosteroids or immunosuppressive therapy within 14 days
- Active uncontrolled infections
- Positive for HIV, active hepatitis B or C
- Significant cardiovascular impairment or recent heart attack/unstable angina
- QTc interval > 480 msec unless cleared by Medical Monitor
- Active or relapsing autoimmune disease except specified controlled conditions
- Pregnancy or lactation
- Serious nonmalignant illness compromising study participation
- Any condition preventing participation as judged by investigator
- Concurrent enrollment in conflicting clinical studies
- Allergy to study drugs or chemotherapy excipients
AI-Screening
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Trial Site Locations
Total: 15 locations
1
Centrum Medyczne Pratia
Poznan, Poland
Actively Recruiting
2
Oncolab S.R.L.
Craiova, Romania
Actively Recruiting
3
Spitalul Clinic Municipal de Urgenta Timisoara/ Clinica de Oncologie Medicala
Timișoara, Romania
Actively Recruiting
4
Changhua Christian Hospital (CCH)
Changhua, Taiwan
Actively Recruiting
5
Taipei Tzu Chi Hospital
Chiayi City, Taiwan
Actively Recruiting
6
Chang-Gung Memorial Hospital - KaoHsiung
Kaohsiung City, Taiwan
Actively Recruiting
7
Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)
Kaohsiung City, Taiwan
Actively Recruiting
8
Chung Shan Medical University Hospital (CSMUH)
Taichung, Taiwan
Actively Recruiting
9
Taipei Medical University Hospital (TMUH)
Taipei, Taiwan
Actively Recruiting
10
Tri-Service General Hospital
Taipei, Taiwan
Actively Recruiting
11
Chang-Gung Memorial Hospital - Linko
Taoyuan City, Taiwan
Actively Recruiting
12
Medicalpark Hastanesi
Adana, Turkey (Türkiye)
Actively Recruiting
13
Liv Hospital
Ankara, Turkey (Türkiye)
Actively Recruiting
14
Göztepe Süleyman Yalçın Şehir Hastanesi
Istanbul, Turkey (Türkiye)
Actively Recruiting
15
İstinye University
Istanbul, Turkey (Türkiye)
Actively Recruiting
Research Team
M
Matthew Failor
CONTACT
I
Imy Chiu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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