Study of zoldonrasib in patients with RAS G12D mutation non-small cell lung cancer who have received previous treatment

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What is this study about?

This study focuses on patients with Non-Small Cell Lung Cancer (NSCLC) that has a specific genetic change called RAS G12D mutation. The study will test a new medication called zoldonrasib (also known as RMC-9805) in patients who have already received previous cancer treatments. This type of lung cancer occurs when cells in the lungs grow abnormally and form tumors.

The purpose of this research is to determine how well zoldonrasib works in treating patients with this specific type of lung cancer. The medication comes in tablet form and is taken by mouth. During the study, patients will receive zoldonrasib daily, with the maximum daily dose being 1200 mg. The treatment period may last up to 9 months.

Throughout the study, doctors will monitor patients’ health and track how their cancer responds to the treatment. They will check the size of tumors and watch for any changes in the patient’s condition. The study will also look at how long the treatment remains effective and track any side effects that may occur. Regular medical examinations and blood tests will be performed to ensure patient safety during the treatment period.

1 Initial evaluation

Your medical condition will be assessed to confirm you have non-small cell lung cancer with a specific genetic change called RAS G12D mutation

Medical tests will check your organ function, including bone marrow, liver, and kidney function

Your tumors will be measured to confirm at least one can be tracked during the study

2 Treatment start

You will receive zoldonrasib (RMC-9805) in tablet form

The medication needs to be taken by mouth

Your healthcare provider will give you specific instructions about when and how to take the tablets

3 Regular monitoring

Your tumor size will be measured regularly using imaging scans

Blood tests will be performed to check the amount of medication in your system

Your overall health will be monitored, including any side effects

Laboratory tests will track changes in your blood values

Your vital signs will be checked during visits

4 Long-term follow-up

Your progress will be tracked for at least 6-12 months

The study team will monitor how long the treatment works

Regular assessments will continue to check your response to the medication

The total study duration may extend until June 2027

Who Can Join the Study?

  • Must be 18 years or older
  • Must have non-small cell lung cancer (NSCLC) with a specific genetic change called RAS-G12D mutation (a specific alteration in the DNA of cancer cells)
  • Must have either:
    • Received previous cancer treatment, or
    • Be unable to receive standard cancer treatments
  • Must have at least one measurable tumor that doctors can track to determine if the treatment is working
  • Must have proper functioning of:
    • Bone marrow (the tissue inside bones that produces blood cells)
    • Liver
    • Kidneys
    • Normal blood clotting ability
  • Both men and women can participate in this study

Who Cannot Join the Study?

  • Prior treatment with any KRAS G12D inhibitor (a type of targeted cancer therapy)
  • Active brain metastases (cancer that has spread to the brain) that are not treated and stable
  • History of another cancer within the past 3 years, except for successfully treated non-melanoma skin cancer or cervical cancer in situ
  • Severe heart conditions including:
    • Heart attack within the past 6 months
    • Unstable angina (chest pain)
    • Severe heart rhythm problems
  • Severe liver problems or abnormal liver function tests
  • Known HIV, active hepatitis B, or active hepatitis C infection
  • Any serious medical condition that could interfere with study participation
  • Pregnant or breastfeeding women
  • Unable to swallow oral medications
  • Known allergies to the study medication or its components
  • Participation in another clinical trial within 30 days before starting this study
  • Any psychological, social, or medical condition that could interfere with the patient’s safety or ability to provide informed consent

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
Oncopole Claudius Regaud Toulouse France
Centr Georges Francois Leclerc Dijon France
Technische Universitaet Dresden Dresden Germany
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Hospital Universitario Y Politecnico La Fe Valencia Spain
Hospital Clinico San Carlos Madrid Spain
Centre Hospitalier Universitaire De Lille Lille France
Hospital Universitario De Navarra Pamplona Spain
Institut Curie – Site Paris Paris France

Other Sites

Site Name City Country Status
Noe LGA Gesundheit Region Mitte GmbH St. Poelten Austria
Hospital Foch Suresnes France
Hospital Universitario 12 De Octubre Madrid Spain
Fundacion Instituto Valenciano De Oncologia Valencia Spain
Henry Dunant Hospital Center Athens Greece
Virgen del Rocío University Hospital Sevilla Spain
Odense University Hospital Odense Denmark
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Hopital Ambroise Pare Boulogne-Billancourt France
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Nemocnice AGEL Novy Jicin a.s. Novy Jicin Czechia
Centre Hospitalier Universitaire De Nantes Nantes France
Rigshospitalet Copenhagen Denmark
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Netherlands Cancer Institute Amsterdam The Netherlands
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Stadt Wien Wiener Gesundheitsverbund Vienna Austria
Centre Francois Baclesse Caen France
Lpjrn Uxhiokpdzjft Mthvjru Cpunlag (tzfrr Leiden The Netherlands
Leama Gvjaivc Hooaefxx Og Adwycl Athens Greece
Unmfoquqjc Hbwvtaqd Cdsdxfa Cologne Germany
Ggggux Ubmycxdytg Ftvnmkxww Frankfurt Germany
Houppkjd Vpwv dzwngqgz Barcelona Spain
Hwzqotln Ufyaznndksiop dq A Ceqzij 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
Austria Austria
Not yet recruiting
01.10.2025
Czechia Czechia
Not yet recruiting
01.10.2025
Denmark Denmark
Not recruiting
01.10.2025
France France
Not recruiting
01.10.2025
Germany Germany
Not yet recruiting
01.10.2025
Greece Greece
Not recruiting
01.10.2025
Italy Italy
Not recruiting
01.10.2025
Spain Spain
Not recruiting
01.10.2025
The Netherlands The Netherlands
Not recruiting
01.10.2025

Trial locations

Zoldonrasib (RMC-9805) is a targeted therapy medication being studied for treating non-small cell lung cancer. It specifically targets tumors with a particular genetic mutation called RAS G12D. This medication is designed to work in patients who have already received previous treatments for their cancer. It works by blocking specific cellular processes that contribute to cancer growth in tumors with this genetic mutation.

Lung Cancer – A disease that begins when abnormal cells in the lungs start to grow uncontrollably, forming tumors that can spread to other parts of the body. The lungs are two spongy organs in the chest that take in oxygen and release carbon dioxide when we breathe. This cancer can develop in any part of the lungs, but most commonly starts in the cells that line the air passages. The disease typically develops gradually, and early stages may not cause noticeable symptoms. As the condition progresses, it may cause persistent coughing, chest pain, shortness of breath, and changes in breathing patterns. Lung cancer can occur in both smokers and non-smokers, though smoking is a major risk factor.

Trial ID:
2025-521681-10-00
Protocol code:
RMC-LUNG-101D
NCT ID:
NCT06162221
Trial Phase:
Therapeutic exploratory (Phase II)

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