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
Centre Hospitalier Universitaire De Lille Lille France
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 Universitario De Navarra Pamplona Spain
Institut Curie – Site Paris Paris France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Nantes Nantes France
Hopital Beaujon Clichy France
Centre Francois Baclesse Caen France
Nki Llu Gpquttiwmx Repfig Munvy Gvdi St. Poelten Austria
Lpzvf Gfwqtou Howxfoej Op Akqhgk Athens Greece
Hcyjjknp Viyh dvnnebkx Barcelona Spain
Hokoxudq Ucuvvwrcszdst dm A Ceaanh A Coruna Galicia Spain
Vrihul dff Rfdpj Ussjqnnynp Hhtqcewf Sevilla Spain
Ukuzbkkrzq Htyqqnno Cdpytvp Cologne Germany
Osrhoa Uxyfuupqbb Hiftfcwb Odense Denmark
Axqa Gkybxd Oyzwvxsc Mydxtfhxxefec Ntpoezfo Milan Italy
Ugawbseulryh Mhdgxqz Cuibpvr Uvocotl Utrecht The Netherlands
Cyxwbce Umlxwgqncoofmvxdxxsu Bnndzz Kqs Berlin Germany
Hboczabu Utykebhzinqqs Fdgjbmuye Jncotbn Dfjs Madrid Spain
Hofsbanw Cswracu Sev Cnpjrh Madrid Spain
Nbvvhjdwe Aahk Nllh Jzrmk abut Novy Jicin Czechia
Rwdqoyvlqjeuoz Copenhagen Denmark
Cpbhzl Hfzsixdmkbw Lrib Snq Pierre Benite France
Hcvcyiit Uupmkjgsjyikk 1t Da Ohmqzal Madrid Spain
Fawymrcyd Ihfvtjnmz Vcijfvegfz Du Oxhzmllxi Valencia Spain
Ssrhf Wfzj Wzcgzd Gadtlyoiscmvevbmxx Vienna Austria
Adhlysp Ofxclsevhznousjfqwrjrsvvo Syd Ldvwx Gvdzwpj Orbassano Italy
Hsuzujn Ajawdono Pdir Boulogne-Billancourt France
Gkavkl Ujuxmcvtrf Fooqknhau Frankfurt Germany
Abfhzeh Uhprn Sxdmagktg Lqushf Dntkn Rvuwweg Faenza Italy
Ncdwmvfpgpf Cqdywx Ikdivyhcy Amsterdam The Netherlands
Hrmjdsdx Fsgi Suresnes France
Lsudz Uiyljppzrkde Mjgbrvv Cvebygj (wifpo Leiden The Netherlands
Hirqu Dmuslc Hjanimlp Cfttnh Athens Greece

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

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
01.10.2025
Czechia Czechia
Not recruiting
01.10.2025
Denmark Denmark
Not recruiting
01.10.2025
France France
Not recruiting
01.10.2025
Germany Germany
Not 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.

Investigated Diseases:

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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