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Carcinoma, Non-Small -Cell LungPhase 3NCT06908304

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

A Phase 3 study testing 6-Thio-2'-Deoxyguanosine, Cemiplimab and Docetaxel in people with Carcinoma, Non-Small -Cell Lung, run by Maia Biotechnology at 15 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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®). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small -Cell Lung
What is being tested?
6-Thio-2'-Deoxyguanosine, Cemiplimab and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
15 sitesin 4 countries
Study dates
8 Dec 2025to 31 Dec 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 (given in combination or in separate lines) for advanced/metastatic disease.
  • Note: The combination of primary therapy followed by maintenance is considered as one line of therapy. Prior treatment with docetaxel is preferred (but not mandated) and is a pre-specified stratification factor.
  • Documented progression or intolerance following the most recent line of therapy.
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  • Stage 4 subjects - must have progressed or relapsed after first-line treatment.
  • Stage 3b subjects - must have already failed, or be ineligible for, local, curative-intent therapy including surgery, and/or chemoradiation.
  • Note: Local, curative-intent therapy including surgery, and/or chemoradiation is not considered a treatment line in the advanced setting.
  • Documented secondary resistance to the prior ICI treatment, as defined by the SITC IRTF (Kluger, 2020):
  • Resistance phenotype Drug exposure requirements Best response Confirmation scan for PD requirement Confirmation scan timeframe Secondary resistance ≥ 6 months CR, PR, SD for > 6 months Yes [1] At least 4 weeks after disease progression (per RECIST V1.1) [1] Other than when tumor growth is very rapid, and subjects are deteriorating clinically.
  • Abbreviations: CR=complete response; PD=progressive disease; PR=partial response; SD=stable disease
  • No prior targeted therapy for driver mutations.
  • At least one measurable target lesion that meets the definition of RECIST v1.1, with documented progression following the most recent line of therapy.
  • An archival tissue sample (formalin fixed paraffin-embedded [FFPE] tissue block or unstained slides) is required if tissue is available at baseline.
  • Note: The sample does not need to be received by the central laboratory prior to Cycle 1, Day 1 (C1D1). Subjects without archival tissue available at baseline may be eligible with Medical Monitor approval.
  • Diagnostic Assessments
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Demonstrate adequate organ function as defined below. All screening laboratories should be performed up to 14 days before initiating IP:
  • Bone marrow function:
  • ○ Neutrophil count ≥ 1500/mm3, hemoglobin ≥ 9.0 g/dL, platelet count ≥ 100,000/mm3
  • Liver function:
  • Total bilirubin ≤ 1.5 x the upper limit of normal (ULN), up to ≤ 3 × ULN if due to Gilbert's syndrome
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 × ULN.
  • Note: For subjects with liver metastases present at baseline, ALT and/or AST ≤ 3 × ULN is permitted.
  • Renal function:
  • ○ Creatinine clearance (CrCl) ≥ 60 mL/min calculated by the Cockcroft-Gault formula using actual body weight (see Table 18) or 24-hour urine collection.
  • Gender and Reproductive Requirements
  • Women of childbearing potential (WOCBP) must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 72 hours prior to receiving the first administration of IP.
  • Contraception use:
  • In the THIO / cemiplimab arm:
  • WOCBP must agree to use a highly effective birth control and refrain from oocyte donation during the study (prior to the first dose with THIO, for the duration of the treatment with THIO, and for six months after the last dose of study treatment, if conception is possible during this interval).
  • Unless permanently sterile by bilateral orchidectomy, male subjects and WOCBP partners of male subjects should use a combination of the methods specified for female subjects in Appendix 4, Section 10.4 along with a male condom, from start of study treatment, for the duration of the treatment, and for six months after the last dose of study treatment. Male subjects should also refrain from sperm donation during this time.
  • In the single-agent chemotherapy arm: For WOCBP, male subjects and WOCBP partners of male subjects, contraception requirements should follow the relevant product's package labelling and standard of care.
  • Note: Contraception use by men or women in both treatment arms should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • Informed Consent 13. Capable and willing to give signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.

Who cannot join

  • For subjects who have received prior treatment with a checkpoint inhibitor: primary resistance to prior checkpoint inhibitor, as defined by the SITC IRTF (Kluger, 2020):
  • Resistance phenotype Drug exposure requirements Best response Confirmation scan for PD requirement Confirmation scan timeframe Primary resistance ≥ 6 weeks PD; SD for < 6 months Yes [1] At least 4 weeks after initial disease progression (per RECIST v1.1) [1] Other than when tumor growth is very rapid, and subjects are deteriorating clinically.
  • Abbreviations: CR=complete response; PD=progressive disease; PR=partial response; SD=stable disease Note: Subjects with drug exposure > 6 weeks who achieved a partial or complete response then progressed before six months, would still be eligible.
  • Untreated or symptomatic central nervous system (CNS) metastases. Note: Subjects with treated asymptomatic brain metastasis are eligible.
  • Prior chemotherapy and/or non-biologic targeted therapy within 28 days, or biologic targeted therapy, immunotherapy, and/or radiation therapy within 42 days prior to start of study treatment.
  • Note: Subjects who receive targeted radiation therapy for localized palliative care may be eligible to start study treatment earlier than 42 days with Medical Monitor agreement.
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  • Prior treatment with cemiplimab.
  • Prior treatment with a targeted therapy for an epidermal growth factor receptor (EGFR) mutation.
  • Received blood, red blood cell or platelet transfusion within 14 days prior to start of study treatment.
  • Any live, attenuated, inactivated or research vaccines within 30 days prior to start of study treatment.
  • Note: Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed.
  • Prior allogeneic hematopoietic stem cell transplant or solid organ transplant.
  • Undergone major surgery within 28 days prior to start of study treatment. Medical conditions
  • Have not recovered to Grade ≤ 1 from adverse events due to prior anti-cancer treatment.
  • Ongoing immune-related / stimulated adverse events (irAEs) from other agents or required permanent discontinuation of prior ICIs due to irAEs.
  • Note: Subjects with resolved irAE may be allowed to enroll following consultation with the Medical Monitor.
  • Active gastrointestinal bleeding as evidenced by either hematemesis or melena.
  • History of another concurrent malignancy other than the present condition (except nonmelanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission and off all therapy for that disease for a minimum of three years.
  • A condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to start of study treatment.
  • Note: Inhaled or topical steroids, adrenal replacement doses 10 mg daily prednisone equivalents, and systemic corticosteroids to manage adverse events are permitted in the absence of active autoimmune disease.
  • Active, uncontrolled bacterial, viral or fungal infections, requiring systemic therapy within 14 days of screening.
  • Positive for Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies), active hepatitis B or hepatitis C.
  • Significant cardiovascular impairment (history of New York Heart Association Functional Classification System Class III or IV) or a history of myocardial infarction or unstable angina within the past six months prior to start of study treatment.
  • QT interval corrected for heart rate (using Fridericia's correction formula; QTcF) > 480 msec at screening (based on average of triplicate electrocardiograms [ECGs] at baseline).
  • Note: If the QTc is prolonged in a subject with a pacemaker or bundle branch block, the subject may be enrolled in the study if confirmed by the Medical Monitor.
  • Active autoimmune diseases or history of autoimmune diseases that may relapse, with the following exceptions:
  • Controlled Type 1 diabetes
  • Hypothyroidism (provided it is managed with hormone replacement therapy only)
  • Controlled celiac disease
  • Skin diseases not requiring systemic treatment (e.g., vitiligo, psoriasis, or alopecia)
  • Any other disease that is not expected to recur in the absence of external triggering factors.
  • Pregnancy or lactating.
  • A serious nonmalignant disease (e.g., psychiatric, substance abuse, uncontrolled intercurrent illness, interstitial lung disease etc.) that could compromise protocol objectives in the opinion of the Investigator and/or the Sponsor.
  • Any other condition that, in the opinion of the Investigator, would prohibit the subject from participating in the study.
  • Prior / concurrent clinical study experience
  • Currently enrolled in a clinical study involving another investigational product or nonapproved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
  • Other
  • History of allergy to excipients of THIO, cemiplimab or any of the chemotherapies under study.

Trial locations and contacts

15 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Matthew Failor contact

704-936-8435

mfailor@maiabiotech.com

Imy Chiu contact

ichiu@maiabiotech.com

15 sites in 4 countries

Taiwan8 sites, 8 recruiting

  • Changhua Christian Hospital (CCH)

    Changhua

    Sheng-Hao Lin

    Recruiting

  • Taipei Tzu Chi Hospital

    Chiayi City

    Chun-Liang Lai

    Recruiting

  • Chang-Gung Memorial Hospital - KaoHsiung

    Kaohsiung City

    Chien-Hao Lai

    Recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)

    Kaohsiung City

    Jen-Yu Hung

    Recruiting

  • Chung Shan Medical University Hospital (CSMUH)

    Taichung

    Gee-Chen Chang

    Recruiting

  • Taipei Medical University Hospital (TMUH)

    Taipei

    Shih-Hsin Hsiao

    Recruiting

  • Tri-Service General Hospital

    Taipei

    Chen-Liang Tsai

    Recruiting

  • Chang-Gung Memorial Hospital - Linko

    Taoyuan City

    Wen-Cheng Change

    Recruiting

Other trials in Taiwan

Turkey (Türkiye)4 sites, 4 recruiting

  • Medicalpark Hastanesi

    Adana

    Ahmet Sezel

    Recruiting

  • Liv Hospital

    Ankara

    Saddettin Kilickap

    Recruiting

  • Göztepe Süleyman Yalçın Şehir Hastanesi

    Istanbul

    Mahmut Gümüş

    Recruiting

  • İstinye University

    Istanbul

    Erkan Kayikcioglu

    Recruiting

Other trials in Turkey (Türkiye)

Romania2 sites, 2 recruiting

  • Oncolab S.R.L.

    Craiova

    Dan Lungulescu

    Recruiting

  • Spitalul Clinic Municipal de Urgenta Timisoara/ Clinica de Oncologie Medicala

    Timișoara

    Razvan Bobora

    Recruiting

Other trials in Romania

Poland1 site, 1 recruiting

  • Centrum Medyczne Pratia

    Poznan

    Marek Kotlarski

    Recruiting

Other trials in Poland

About this study

Official title: 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

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.

Being tested
6-Thio-2'-Deoxyguanosine, Cemiplimab, Docetaxel, Vinorelbine, Gemcitabine alone
Keywords
squamous cell carcinoma, Adenocarcinoma, Non-Small Cell Lung Carcinoma, Non-Small Cell Lung Cancer, Large Cell Carcinoma
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Carcinoma, Squamous Cell, Adenocarcinoma, Carcinoma, Large Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 6-Thio-2'-DeoxyguanosineDrug

    Also called 6-thio-dG, THIO, ateganosine

    small molecule telomere targeting agent

  • CemiplimabDrug

    Also called LIBTAYO®

    programmed cell death protein 1 (PD-1) inhibitor

  • DocetaxelDrug

    Also called Taxotere, Docecad

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

  • VinorelbineDrug

    Also called Navelbine, Vinorelbine tartrate

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

  • Gemcitabine aloneDrug

    Also called Gemzar

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

Study groups in NCT06908304
Study groupRoleWhat they receive
THIO + Cemiplimab ArmExperimentalTHIO 60mg, 30-min IV infusions, Days 1-3 (180 mg/Cycle) Cemplimab 350 mg, 30-min IV infusion, Day 5 3-Week Cycle
Receives: Drug: 6-Thio-2'-Deoxyguanosine; Drug: Cemiplimab
Investigator's choice of single-agent chemotherapy (vinorelbine, gemcitabine, or docetaxel)Active comparatorChemotherapy Agent [1] Dosing Regimen No. of Subjects (Planned) Option 1: Vinorelbine 30 mg/m2 IV on D1, D8, and D15 Q3W ~150 [3] Option 2: Gemcitabine 1250 mg/m2 IV on D1 and D8 Q3W Option 3: Docetaxel 75 mg/m2 IV on D1 Q3W [2] Abbreviations: D = day (within a 21-day cycle); IV= intravenous; Q3W=every 3 weeks (21-day cycles) 1. Standard of Care (for example vinorelbine, gemcitabine, or docetaxel chemotherapy, if not previously exposed, per Investigator's Choice) 2. Docetaxel 60-65 mg/m2 permitted based on country-specific approvals. 3. Within the control arm, there are no limits on the number of subjects who can be treated with any of the chemotherapy agents.
Receives: Drug: Docetaxel; Drug: Vinorelbine; Drug: Gemcitabine alone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    Overall survival as defined as the time from randomization to death from any cause.

    Measured: Within 2 Years

Secondary outcomes (5)

  1. Objective Radiographic Response

    Objective Radiographic Response as defined as the proportion of subjects demonstrating a confirmed objective response of complete response or partial response.

    Measured: Within 2 Years

  2. Disease Control Rate

    Disease Control Rate as defined as the proportion of subjects demonstrating complete response, partial response, or stable disease after 2 treatment cycles.

    Measured: Within 2 Years

  3. Duration of Response

    Duration of Response as defined as the time from response complete response or partial response to progressive disease.

    Measured: Within 2 Years

  4. Progressive Free Survival

    Progressive Free Survival as defined as the time from randomization to the first occurrence of progressive disease or death from any cause, whichever occurs first.

    Measured: Within 2 Years

  5. Treatment Emergent Adverse events and Serious Adverse Events

    Incidence of Treatment Emergent Adverse events and Serious Adverse Events leading to discontinuation of study medication (THIO and/or cemiplimab) and/or withdrawal from the study.

    Measured: Within 2 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2025
  2. Study start8 Dec 2025
  3. Primary completion31 Jul 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06908304
Sponsor's protocol ID
THIO-104
Other IDs
2024-520164-33-00
Status last verified
Jan 2026
First submitted
20 Mar 2025
Last updated
12 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 6-Thio-2'-Deoxyguanosine, Cemiplimab and Docetaxel in people with Carcinoma, Non-Small -Cell Lung, run by Maia Biotechnology at 15 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 36 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Taiwan, Turkey (Türkiye), Romania, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Matthew Failor (704-936-8435, mfailor@maiabiotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: Within 2 Years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06908304.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026; AzTrials last refreshed its copy on 31 Oct 2026.

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