Study of THIO and cemiplimab compared to chemotherapy in patients with advanced non-small cell lung cancer who have received two previous treatments

3 1 1 1

What is this study about?

This study focuses on patients with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) who have already received two previous treatments. The study compares two different treatment approaches. The first approach uses a combination of two medications: THIO followed by cemiplimab (also known as LIBTAYO). The second approach uses one of several standard chemotherapy medications: gemcitabine, vinorelbine, or docetaxel.

The purpose of this research is to determine if using THIO followed by cemiplimab helps patients with advanced NSCLC live longer compared to using standard chemotherapy alone. Both treatments are given through an intravenous infusion, which means the medication is delivered directly into the bloodstream through a vein.

During the study, patients will be randomly assigned to receive either the THIO/cemiplimab combination or one of the standard chemotherapy medications. The treatment period may continue for up to 24 months. Throughout the study, doctors will monitor patients’ health and track how their cancer responds to the treatment. They will also watch for any side effects that may occur during the treatment period.

1 Initial evaluation

Your eligibility will be confirmed through medical tests up to 14 days before starting treatment

Laboratory tests will check your bone marrow function, liver function, and kidney function

If you are a woman who can become pregnant, a pregnancy test will be required within 72 hours before starting treatment

2 Treatment assignment

You will be randomly assigned to one of two treatment groups:

Group 1: THIO followed by cemiplimab (LIBTAYO®) treatment

Group 2: Single chemotherapy medicine chosen by your doctor (either gemcitabine, vinorelbine, or docetaxel)

3 Treatment administration

All medications will be given through an intravenous (IV) infusion (directly into your vein)

Your treatment will continue until either your disease progresses or you experience unacceptable side effects

Regular assessments will monitor your response to treatment and any side effects

4 Follow-up period

Your health will be monitored throughout the study period

The study will track how long you live without your disease getting worse (progression-free survival)

The study will continue until 2028

5 Safety monitoring

Throughout the study, you will be monitored for side effects

Any serious side effects or reactions that lead to stopping treatment will be recorded

Regular medical examinations and laboratory tests will be performed to ensure your safety

Who Can Join the Study?

  • Must be at least 18 years of age
  • Must have adequate organ function including:
    – Proper bone marrow function (specific blood cell counts)
    – Normal liver function (within specified limits)
    – Healthy kidney function (specific creatinine clearance levels)
  • Women who can become pregnant must have a negative pregnancy test within 72 hours before starting treatment
  • Must agree to use effective birth control methods during the study and for 6 months after the last treatment:
    – Applies to women who can become pregnant
    – Applies to male participants and their female partners
    – Men must also avoid sperm donation during this period
  • Must be willing and able to provide informed consent
  • Must have Stage 3b or 4 Non-Small Cell Lung Cancer (confirmed by tissue or cell examination)
  • Must have received two previous treatments for advanced cancer, including:
    – Immunotherapy (anti-PD-1/PD-L1)
    – Platinum-based chemotherapy
  • Must show that previous treatment was not effective or could not be tolerated
  • Must have documented resistance to previous immunotherapy treatment
  • Must not have received previous targeted therapy for genetic mutations
  • Must have at least one measurable tumor that can be tracked during the study
  • Must provide a tissue sample from previous biopsies if available
  • Must have good physical function ability (ECOG performance status of 0-1, meaning able to perform daily activities with minimal assistance)

Who Cannot Join the Study?

  • Active or untreated brain metastases (cancer that has spread to the brain)
  • Previous treatment with cemiplimab (a type of immunotherapy drug)
  • Known allergies to the study medications
  • Severe heart conditions or uncontrolled high blood pressure
  • Active or chronic infections, including hepatitis B, hepatitis C, or HIV
  • Other types of cancer within the last 3 years (except for successfully treated skin cancer or early-stage cancer)
  • Autoimmune diseases requiring systemic treatment (conditions where the immune system attacks healthy cells)
  • Severe lung disease or breathing problems
  • Pregnancy or breastfeeding
  • Use of systemic steroids or other immunosuppressive medications (drugs that weaken the immune system)
  • Major surgery within 4 weeks before starting the study
  • Participation in other clinical trials within 4 weeks before this study
  • Any condition that, in the opinion of the study doctor, would make participation unsafe

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M. I M. Nastaj. sp.p. Lublin Poland
Medisprof S.R.L. Cluj Napoca Romania
Koranyi National Institute For Pulmonology Budapest Hungary
Hospital Universitario Y Politecnico La Fe Valencia Spain

Other Sites

Site Name City Country Status
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie Olsztyn Poland
Centrul De Oncologie-Euroclinic S.R.L. Iasi Romania
Oncolab S.R.L. Craiova Romania
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet Szolnok Hungary
Radiotherapy Center Cluj S.R.L. Floresti Romania
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o. Siedlce Poland
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti Bucharest Romania
Ovidius Clinical Hospital S.R.L. Ovidiu Romania
Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego Walbrzych Poland
Centrul De Oncologie SF Nectarie S.R.L. Craiova Romania
Med Polonia Sp. z o.o. Poznan Poland
Matrai Gyogyintezet Gyongyos Hungary
Spitalul Clinic Municipal De Urgenta Timisoara Timisoara Romania
Semmelweis University Budapest Hungary
Oncomed S.R.L. Timisoara Romania
Pratia S.A. Skorzewo Poland
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach Kielce Poland
Tuedogyogyintezet Toeroekbalint Torokbalint Hungary
Szpital Specjalistyczny W Prabutach Sp. z o.o. Prabuty Poland
Instytut Centrum Zdrowia Matki Polki Lodz Poland
Hospital Da Luz S.A. Lisbon Portugal
Centro Hospitalar Universitario De Santo Antonio E.P.E. Porto Portugal
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy Otwock Poland
Hospital Son Llatzer Palma Spain
Servei De Salut De Les Illes Balears Palma Spain
Fundacion Instituto Valenciano De Oncologia Valencia Spain
Hospital Universitario De Jaen Jaen Spain
Hospital Universitario Torrecardenas Almeria Spain
Hospital Universitario Virgen De La Victoria Malaga Spain
Wamklzhvkzw Wdasvoyarmfcrurizkbg Cdkeigq Opjkiirba I Tkxspjgvyyljg Ig Monzgkqrjwi W Lfovc Lodz Poland
Bkmltebrajf Vthpqfvap Orthvpouafmh Kecskemet Hungary
Nltjjwgf Iylvbnuc Oaponpygo Ipr Mfdhf Souqgvdthstlxjfmfmkaqkdkevfd Ifrihque Bpcupfqb Cracow Poland
Hyboxylc Vdvb dbnxunxu Barcelona Spain
Ikiriihe Cdatvx Dfeypjngxnffmpdag L'hospitalet De Llobregat Spain
Hnfaahja Uxbcslrbdqtvo Da Bxgdldg Badajoz Spain
Fsainlpkx Pwoz Lq Ighpanmbsvlqh Bjdjetiyv Dnm Hpkgqsau Ulwyzoxobrqar Lv Pyy Madrid Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Hungary Hungary
Recruiting
08.09.2025
Poland Poland
Recruiting
08.09.2025
Portugal Portugal
Not yet recruiting
08.09.2025
Romania Romania
Recruiting
08.09.2025
Spain Spain
Not yet recruiting
08.09.2025

Trial locations

THIO is an investigational drug being studied for the treatment of advanced non-small cell lung cancer. It is designed to be used as part of a third-line treatment approach for patients whose cancer has progressed after previous treatments.

Cemiplimab (also known as LIBTAYO) is an immunotherapy medication that helps the body’s immune system recognize and fight cancer cells. It works by targeting and blocking a protein called PD-1, which can help the immune system better attack cancer cells.

Single-agent Chemotherapy refers to traditional cancer treatments that use one chemotherapy drug to kill cancer cells or stop them from growing. In this trial, the specific chemotherapy medication is chosen by the treating physician from available options.

Non-Small Cell Lung Cancer – A type of lung cancer that begins in the cells of the lungs and gradually forms tumors. It develops when healthy cells in the lung tissue begin to grow uncontrollably and form masses. The disease typically starts in the cells that line the airways of the lungs. It is characterized by the growth and spread of abnormal cells in the lung tissue, which can affect breathing and other bodily functions. The disease can progress from early stages where it is confined to the lungs to more advanced stages where it may spread to nearby tissues.

Trial ID:
2024-520164-33-00
Protocol code:
THIO-104
Trial Phase:
Therapeutic confirmatory (Phase III)

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