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2025-521681-10-00Active, not recruitingPhase 2

Study of zoldonrasib in Previously Treated Patients with RAS G12D-Mutant Non-Small Cell Lung Cancer (NSCLC)

A Phase 2, Open-Label, Multicenter Study of Zoldonrasib(RMC-9805) in Previously Treated Patients with RAS G12DMutant Non-Small Cell Lung Cancer (NSCLC) – Subprotocol D

Source: EU CTIS (euclinicaltrials.eu) · Last updated 26 Aug 2026

Next steps

Brief summary (registry, in English)

To evaluate the ORR as assessed by RECIST v1.1 criteria of zoldonrasib monotherapy in patients with RAS G12D-mutant NSCLC who have been previously treated with systemic therapy

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
91 (estimated)
First submitted
28 May 2025
Start date
2 Oct 2025
Lead sponsor
Revolution Medicines Inc.
Diseases
Lung cancer
EU CT number
2025-521681-10-00

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 91
  • 42 sites in 9 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients that have gastrointestinal problems that may affect absorption of the study drug medicine
  • Patients thathad any major surgery in the last 4 weeks.
  • Patients that have previously taken targeted therapy for KRAS mutation.

Other illness

  • Patients that have any other medical condition that may interfere with the study medicine.
  • Patient that have a history of severe allergic reactions to the study medicine.

Other

  • Patients that have primary brain and spinal cord tumor.

Who the study is looking for

  • Patients that are at least 18 years of age
  • Patients that have NSCLC with RAS-G12D mutation
  • Patients that have had cancer treatment before or are not able to tolerate regular treatments.
  • Patients that have at least 1 measurable tumor (lesion).
  • Patients that have adequate organ function (bone marrow, liver, kidney) and blood clotting.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (42)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Noe LGA Gesundheit Region Mitte GmbHSt. PoeltenAustriaCompleted
Stadt Wien Wiener GesundheitsverbundViennaAustriaCompleted
Nemocnice AGEL Nový Jičín a.s.Nový JičínCzechiaCompleted
Charite Universitaetsmedizin Berlin KöRBerlinGermanyCompleted
University Hospital Cologne AöRCologneGermanyCompleted
Technische Universitaet DresdenDresdenGermanyCompleted
Goethe University FrankfurtFrankfurt Am MainGermanyCompleted
RigshospitaletCopenhagen OeDenmarkCompleted
Odense University HospitalOdense CDenmarkCompleted
Complexo Hospitalario Universitario A CoruñaA CoruñaSpainActive, not recruiting
Hospital Universitari Vall d'HebronBarcelonaSpainActive, not recruiting
Hospital Universitario Fundación Jiménez DíazMadridSpainActive, not recruiting
Clinica Universidad de NavarraMadridSpainActive, not recruiting
Hospital Clínico San CarlosMadridSpainActive, not recruiting
Hospital Universitario Ramón y CajalMadridSpainActive, not recruiting
Hospital Universitario 12 de OctubreMadridSpainActive, not recruiting
Hospital Universitario Regional de MálagaMálagaSpainActive, not recruiting
Clínica Universidad de navarraPamplonaSpainActive, not recruiting
University Hospital Virgen Del Rocio S.L.SevillaSpainActive, not recruiting
Hospital Universitario Y Politecnico La FeValenciaSpainActive, not recruiting
Fundación Instituto Valenciano de OncologíaValenciaSpainActive, not recruiting
Institut BergonieBordeauxFranceActive, not recruiting
Hôpital Ambroise-ParéBoulogne-BillancourtFranceActive, not recruiting
Hospices Civils de LyonBronFranceActive, not recruiting
Centre Francois BaclesseCaen Cedex 5FranceActive, not recruiting
Centr Georges Francois LeclercDijonFranceActive, not recruiting
Centre Hospitalier Universitaire de LilleLilleFranceActive, not recruiting
Assistance Publique Hopitaux de ParisParisFranceActive, not recruiting
Institut CurieParisFranceActive, not recruiting
Centre Hospitalier Universitaire de NantesSaint-HerblainFranceActive, not recruiting
Hospital FochSuresnesFranceActive, not recruiting
Oncopole Claudius RegaudToulouse Cedex 9FranceActive, not recruiting
Institut Gustave RoussyVillejuifFranceActive, not recruiting
Thoracic General Hospital of Athens "I Sotiria"AthensGreeceCompleted
Henry Dunant Hospital CenterAthensGreeceCompleted
ASST Grande Ospedale Metropolitano NiguardaMilanItalyActive, not recruiting
Azienda Ospedaliero-Universitaria San Luigi GonzagaOrbassanoItalyActive, not recruiting
Azienda Unità Sanitaria Locale della RomagnaRavennaItalyActive, not recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCSRomeItalyActive, not recruiting
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis StichtingAmsterdamNetherlandsActive, not recruiting
Leids Universitair Medisch Centrum (LUMC)LeidenNetherlandsActive, not recruiting
Universitair Medisch Centrum UtrechtUtrechtNetherlandsActive, not recruiting

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This page is information, not medical advice. Discuss any trial with your doctor.