Study of AMG 193 tablets for patients with advanced non-small cell lung cancer (NSCLC) who have previously received treatment and have MTAP gene deletion

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What is this study about?

This study focuses on people with advanced Non-Small Cell Lung Cancer (NSCLC) that has a specific genetic characteristic called MTAP deletion. This type of lung cancer has already been treated with at least one previous therapy but has continued to progress. The cancer is either spread to other parts of the body (metastatic) or cannot be removed through surgery (unresectable).

The study will test a new medication called AMG 193, which is given as tablets taken by mouth. This research aims to understand how well AMG 193 works and how safe it is for patients at two different dose levels. The study consists of two parts, and doctors will monitor how patients respond to the treatment using special imaging tests like computed tomography (CT) or Magnetic Resonance Imaging (MRI).

During the study, researchers will track various aspects of the treatment’s effectiveness, including how many patients’ tumors shrink or disappear, how long the treatment benefits last, and how long patients survive without their disease getting worse. They will also collect information about any side effects that occur and measure the amount of medication in patients’ bodies. Additionally, patients will complete questionnaires about their symptoms and overall health throughout the study.

1 Initial assessment

Your medical history and condition will be reviewed to confirm you have advanced non-small cell lung cancer with MTAP deletion.

A tissue sample from your previous biopsy will be required for analysis.

If you have brain metastases, they must be either treated and stable for at least 14 days, or be untreated but smaller than 2 cm and not causing symptoms.

2 Treatment initiation

You will receive AMG 193 in tablet form to take by mouth.

The treatment will be administered at one of two dose levels, which will be determined by your doctor.

Your response to the treatment will be monitored through regular imaging scans (CT or MRI).

3 Ongoing monitoring

Regular assessments will track how your cancer responds to the treatment.

Your doctor will monitor any side effects that may occur during treatment.

You will be asked to complete questionnaires about your symptoms and overall health.

Blood samples will be taken to measure the levels of AMG 193 in your body.

4 Treatment duration

The study will continue until December 2028.

Your participation may end earlier if your disease progresses or if you experience unacceptable side effects.

Your doctor will regularly assess if continuing the treatment is beneficial for you.

Who Can Join the Study?

  • You must have confirmed non-small cell lung cancer that has spread to other parts of the body (metastatic) or cannot be surgically removed (unresectable), with a specific genetic feature called MTAP deletion in the tumor tissue
  • You must have previously received at least 1 treatment for your advanced cancer and experienced disease progression or recurrence after that treatment
  • You must have a previously collected tumor tissue sample available for testing
  • Your doctor must determine that your life expectancy is greater than 3 months
  • If you have had cancer spread to the brain (brain metastases), you may participate if:
    • You have received treatment with radiation or surgery that was completed at least 14 days before starting the study, or
    • You have untreated brain metastases that are 2 centimeters or smaller, cause no symptoms, and do not require steroid treatment
  • Both men and women may participate
  • You must be an adult (18 years or older)

Who Cannot Join the Study?

  • Prior treatment with any MTAP/PRMT5 targeted therapy (substances that affect specific proteins in cancer cells)
  • Active brain metastases (cancer that has spread to the brain) or spinal cord compression that requires treatment
  • History of another type of cancer in the past 3 years, except for successfully treated skin cancer or early-stage cancer
  • Severe heart conditions including:
    – Heart attack within past 6 months
    – Unstable angina (chest pain)
    – Heart failure requiring treatment
    – Uncontrolled high blood pressure
  • Serious infections requiring intravenous antibiotics
  • Known infection with HIV, active hepatitis B, or active hepatitis C
  • Major surgery within 28 days before starting the study treatment
  • Pregnancy or breastfeeding
  • Any medical condition that could interfere with the study medication absorption
  • Mental health conditions that could affect ability to follow study requirements
  • Use of other experimental drugs within 28 days before starting this study
  • Known allergies to similar medications
  • Abnormal laboratory test results that suggest significant organ dysfunction

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Technische Universitaet Dresden Dresden Germany
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
IRCCS Humanitas Research Hospital Rozzano Italy
Koranyi National Institute For Pulmonology Budapest Hungary
Centre Hospitalier Universitaire De Lille Lille France
Futuremeds Sp. z o.o. Wroclaw Poland
Oncopole Claudius Regaud Toulouse France
Katholieke Universiteit te Leuven Leuven Belgium
Comite Entreprise Paul Papin Angers France
Institut Curie – Site Paris Paris France

Other Sites

Site Name City Country Status
Pauls Stradins Clinical University Hospital Riga Latvia
Farkasgyepui Tudogyogyintezet Farkasgyepu Hungary
Centro Ricerche Cliniche Di Verona S.r.l. Verona Italy
Universitair Ziekenhuis Gent Gent Belgium
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Del Mar Barcelona Spain
Masarykuv Onkologicky Ustav Brno-Stred Czechia
Algemeen Ziekenhuis Delta Roeselare Belgium
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
University General Hospital Of Heraklion Heraklion Greece
LungenClinic Grosshansdorf GmbH Grosshansdorf Germany
Ziekenhuis St Jansdal Harderwijk The Netherlands
Henry Dunant Hospital Center Athens Greece
Bioclinic S.A. Thessaloniki Greece
Matrai Gyogyintezet Gyongyos Hungary
Metropolitan General Hospital/Healthcare Facilities Operation And Management Single Member S.A Cholargos Greece
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Semmelweis University Budapest Hungary
Champalimaud Clinical Centre Lisbon Portugal
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy Warsaw Poland
Wojewodzki Szpital Specjalistyczny Nr 4 W Bytomiu Samodzielny Publiczny Zaklad Opieki Zdrowotnej Bytom Poland
St. Luke’s Hospital S.A. Thessaloniki Greece
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
University Hospital Olomouc Olomouc Czechia
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow Poznan Poland
Thoraxklinik Heidelberg gGmbH Heidelberg Germany
Netherlands Cancer Institute Amsterdam The Netherlands
Hopital Beaujon Clichy France
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Fakultni Thomayerova nemocnice Prague Czechia
Hospital CUF Porto S.A. Porto Portugal
Metropolitan Hospital Athens Greece
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaidari Greece
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Upreattyuwajbogpbrvjm Ennbf Arh Essen Germany
Nxggxgsm Ieqrpolar Ob Tfmngblwlfbm Aol Ltvr Dziyzsrj Warsaw Poland
Diyvhtdkocqw Cazmjse Ogszklvrw Pjtmrnhrlbcg I Hlldyjkqzig Wroclaw Poland
Lqnop Gffzgnf Hmripsqr Or Ayernn Athens Greece
Aivutdzafx Pzrzrwvh Hlcublpb Du Mnckrlfyl Marseille France
Eeqbrmo Uzqgtwrqwmly Mihawmw Cjrskde Rmyavlrun (ourdajm Mym Rotterdam The Netherlands
Rpzij Abmztmrf knzfytrb udyjembnksaia seghphvv Sbl Riga Latvia
Glgipnvdeqzkwukqy Vtkgjyopk Pizk Azdeba Eabcjvyo Oyiwvk Kkjzdg Gyor Hungary
Nxwfepfr Iqmvgfjg Ofsjqifyk Ijn Mmopq Shqbcrmdwxukeqqnuqxzwyqcmewo Itfzvrlf Bagtnpep Cracow Poland
Uveoqssmwktqmvwdtnbna Wccjvtdxf Aln Wuerzburg Germany
Hgpwhitt Da Li Skazd Cqth I Shbj Pxm Barcelona Spain
Ujprizogyx Or Akpeunb Edegem Belgium
Hdchcjkf Vima dhjmynxx Barcelona Spain
Hrxqrzta Unutptjuxhucr dn A Chkrfa A Coruna Galicia Spain

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
23.04.2025
Czechia Czechia
Not recruiting
23.04.2025
France France
Not recruiting
23.04.2025
Germany Germany
Not recruiting
23.04.2025
Greece Greece
Not recruiting
23.04.2025
Hungary Hungary
Not recruiting
23.04.2025
Italy Italy
Not recruiting
23.04.2025
Latvia Latvia
Not recruiting
23.04.2025
Poland Poland
Not recruiting
23.04.2025
Portugal Portugal
Not recruiting
23.04.2025
Spain Spain
Not recruiting
23.04.2025
The Netherlands The Netherlands
Not recruiting
23.04.2025

Trial locations

Investigated drugs:

AMG 193 is an investigational medication being studied in cancer treatment. It targets specific types of non-small cell lung cancer (NSCLC) that have a particular genetic characteristic – the deletion of an enzyme called methylthioadenosine phosphorylase (MTAP). This medication is being tested in patients who have previously received other treatments for their advanced lung cancer. The trial is evaluating how well the medication works and how safe it is when given to patients at different dose levels.

Non-Small Cell Lung Cancer – A type of lung cancer that begins in the cells of the lungs and forms a mass of tissue known as a tumor. It develops when healthy cells in the lung tissue begin to grow uncontrollably and abnormally. The disease typically starts in the cells that line the airways of the lungs (bronchi). As the cancer grows, it can spread to nearby tissues and form new tumors. Non-small cell lung cancer accounts for the majority of all lung cancer cases and tends to grow and spread more slowly than small cell lung cancer.

Trial ID:
2024-514459-14-00
Protocol code:
20230153
NCT ID:
NCT06593522
Trial Phase:
Therapeutic exploratory (Phase II)

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