Clinical trial • Phase II • Oncology|Respiratory

(2S)-2-CYCLOPENTYL-2-[(5S)-2-[(2R,3R)-3-CYCLOPROPYL-1-METHYLAZIRIDINE-2-CARBONYL]-2,7-DIAZASPIRO[4.4]NONAN-7-YL]-N-[(6S,8S,14S)-21-[5-(4-CYCLOPROPYLPIPERAZIN-1-YL)-2-[(1S)-1-METHOXYETHYL]PYRIDIN-3-YL]-18,18-DIMETHYL-9,15-DIOXO-22-(2,2,2-TRIFLUOROETHYL)-5,16-DIOXA-2,10,22,28-TETRAZAPENTACYCLO[18.5.2.12,6.110,14.023,27]NONACOSA-1(26),20,23(27),24-TETRAEN-8-YL]ACETAMIDE for Non-small cell lung cancer|Lung cancer

Phase II trial of (2S)-2-CYCLOPENTYL-2-[(5S)-2-[(2R,3R)-3-CYCLOPROPYL-1-METHYLAZIRIDINE-2-CARBONYL]-2,7-DIAZASPIRO[4.4]NONAN-7-YL]-N-[(6S,8S,14S)-21-[5-(4…

Overview

Trial Therapeutic Area
Oncology|Respiratory
Trial Disease
Non-small cell lung cancer|Lung cancer
Trial Stage
Phase II
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
28-05-2025
First CTIS Authorization Date
22-09-2025

Trial design

open-label Phase II trial in Spain, Czechia, Denmark and others.

Open Label
Yes
Target Sample Size
84

Eligibility

Recruits 84 adults.

Inclusion criteria

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

Exclusion criteria

  • {"criterion_text":"- 1. Patients that have primary brain and spinal cord tumor."}
  • {"criterion_text":"- 2. Patients thathave gastrointestinal problems that may affect absorption of RMC-9805"}
  • {"criterion_text":"- 3. Patients thathad any major surgery in the last 4 weeks."}
  • {"criterion_text":"- 4. Patients that have any other medical condition that may interfere with the study medicine."}
  • {"criterion_text":"- 5. Patient that have a history of severe allergic reactions to the study medicine."}
  • {"criterion_text":"- 6. Patients that have previously taken targeted therapy for KRAS mutation."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Confirmed ORR per RECIST v1.1 as assessed by BICR","definition_or_measurement_approach":"Objective response rate (ORR) assessed per RECIST v1.1 criteria by Blinded Independent Central Review (BICR)."}

Secondary endpoints

  • {"endpoint_text":"- •PFS","definition_or_measurement_approach":"Progression-free survival (PFS) as commonly defined (time from treatment start to progression or death)."}
  • {"endpoint_text":"- • OS","definition_or_measurement_approach":"Overall survival (OS) (time from treatment start to death from any cause)."}
  • {"endpoint_text":"- • DOR","definition_or_measurement_approach":"Duration of response (DOR) (time from initial documented response to progression or death)."}
  • {"endpoint_text":"- • TTR","definition_or_measurement_approach":"Time to response (TTR) (time from treatment start to first documented response)."}
  • {"endpoint_text":"- • DCR","definition_or_measurement_approach":"Disease control rate (DCR) (proportion of patients with response or stable disease)."}
  • {"endpoint_text":"- • PFS rate at 6 months and 12 months and OS rate at 12 months","definition_or_measurement_approach":"PFS and OS rates at specified timepoints (proportion of patients progression-free or alive at 6, 12 months)."}
  • {"endpoint_text":"- • Incidence of TEAEs, SAEs, and changes from baseline in clinical laboratory values and vital signs.","definition_or_measurement_approach":"Safety/tolerability measured by incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and laboratory/vital sign changes from baseline."}
  • {"endpoint_text":"- • Zoldonrasib blood concentration over time","definition_or_measurement_approach":"Pharmacokinetic measurements of zoldonrasib blood/plasma concentration over time."}

Recruitment

Planned Sample Size
84
Recruitment Window Months
20
Consent Approach
Informed consent is obtained from adult participants (study inclusion requires patients to be at least 18 years of age). Subject information and informed consent forms (main ICF, pre-screening ICF, pregnancy-related ICF) are provided and published for participating countries. ICFs are available in multiple languages as supplied in the trial documentation (examples include Spanish, Czech, Danish, French, German, Greek, Italian, Dutch and English). A specific Pregnant Partner ICF is also provided where applicable.

Geography

Total Number Of Sites
42
Total Number Of Participants
84

Spain

Earliest CTIS Part Ii Submission Date
28-08-2025
Latest Decision Or Authorization Date
25-09-2025
Processing Time Days
28
Number Of Sites
12
Number Of Participants
19

Sites

Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncologia
Principal Investigator Name
Luis Paz-Ares Rodriguez
Principal Investigator Email
luis.paz-ares@salud.madrid.org
Contact Person Name
Luis Paz-Ares Rodriguez
Contact Person Email
luis.paz-ares@salud.madrid.org
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Oncologia Medica
Principal Investigator Name
Maria Rosario Garcia Campelo
Principal Investigator Email
ma.rosario.garcia.campelo@sergas.es
Contact Person Name
Maria Rosario Garcia Campelo
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Oncologia
Principal Investigator Name
Alejandro Falcon
Principal Investigator Email
afalconglez@gmail.com
Contact Person Name
Alejandro Falcon
Contact Person Email
afalconglez@gmail.com
Site Name
Hospital Clinico San Carlos
Department Name
Oncologia
Principal Investigator Name
Jorge Bartolome
Principal Investigator Email
Jorge.bartolome@salud.madrid.org
Contact Person Name
Jorge Bartolome
Site Name
Clinica Universidad De Navarra
Department Name
Oncologia
Principal Investigator Name
Miguel Fernandez De Sanmamed
Principal Investigator Email
msanmamed@unav.es
Contact Person Name
Miguel Fernandez De Sanmamed
Contact Person Email
msanmamed@unav.es
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Oncologia
Principal Investigator Name
Oscar Juan Vidal
Principal Investigator Email
juan_osc@gva.es
Contact Person Name
Oscar Juan Vidal
Contact Person Email
juan_osc@gva.es
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Oncologia
Principal Investigator Name
Pilar Garrido
Principal Investigator Email
pgarrido@salud.madrid.org
Contact Person Name
Pilar Garrido
Contact Person Email
pgarrido@salud.madrid.org
Site Name
Hospital Universitario Regional De Malaga
Department Name
Oncologia Medica
Principal Investigator Name
Vanesa Gutierrez
Principal Investigator Email
vgutierrezcald@gmail.com
Contact Person Name
Vanesa Gutierrez
Contact Person Email
vgutierrezcald@gmail.com
Site Name
Fundacion Instituto Valenciano De Oncologia
Department Name
Oncologia
Principal Investigator Name
David Lorente Estelles
Principal Investigator Email
dlorente@fivo.org
Contact Person Name
David Lorente Estelles
Contact Person Email
dlorente@fivo.org
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Oncologia
Principal Investigator Name
Bernard Doger de Speville Uribe
Principal Investigator Email
bernard.doger@startmadrid.com
Contact Person Name
Bernard Doger de Speville Uribe
Contact Person Email
bernard.doger@startmadrid.com
Site Name
Clinica Universidad De Navarra (Madrid site)
Department Name
Oncologia
Principal Investigator Name
Miguel Fernandez De Sanmamed
Principal Investigator Email
msanmamed@unav.es
Contact Person Name
Miguel Fernandez De Sanmamed
Contact Person Email
msanmamed@unav.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncologia
Principal Investigator Name
Patricia Iranzo
Principal Investigator Email
piranzo@vhio.net
Contact Person Name
Patricia Iranzo
Contact Person Email
piranzo@vhio.net

Czechia

Earliest CTIS Part Ii Submission Date
03-09-2025
Latest Decision Or Authorization Date
24-09-2025
Processing Time Days
21
Number Of Sites
1
Number Of Participants
5

Sites

Site Name
Nemocnice AGEL Novy Jicin a.s.
Principal Investigator Name
Vojtěch Tlustý
Principal Investigator Email
vojtech.tlusty@nnj.agel.cz
Contact Person Name
Vojtěch Tlustý
Contact Person Email
vojtech.tlusty@nnj.agel.cz

Denmark

Earliest CTIS Part Ii Submission Date
17-09-2025
Latest Decision Or Authorization Date
22-09-2025
Processing Time Days
5
Number Of Sites
2
Number Of Participants
8

Sites

Site Name
Rigshospitalet
Department Name
Department of Oncology
Principal Investigator Name
Kristoffer Staal Rohrberg
Principal Investigator Email
Kristoffer.Staal.Rohrberg@regionh.dk
Contact Person Name
Kristoffer Staal Rohrberg
Site Name
Odense University Hospital
Department Name
Department of Oncology
Principal Investigator Name
Lise EckHoff
Principal Investigator Email
Line.Korfitz.Stenhoj@rsyd.dk
Contact Person Name
Lise EckHoff
Contact Person Email
Line.Korfitz.Stenhoj@rsyd.dk

France

Earliest CTIS Part Ii Submission Date
25-08-2025
Latest Decision Or Authorization Date
26-09-2025
Processing Time Days
32
Number Of Sites
12
Number Of Participants
17

Sites

Site Name
Hospital Foch
Principal Investigator Name
Jaafar BENNOUNA
Principal Investigator Email
j.bennouna@hopital-foch.com
Contact Person Name
Jaafar BENNOUNA
Contact Person Email
j.bennouna@hopital-foch.com
Site Name
Centr Georges Francois Leclerc
Principal Investigator Name
François GHIRINGHELLI
Principal Investigator Email
fghiringhelli@cgfl.fr
Contact Person Name
François GHIRINGHELLI
Contact Person Email
fghiringhelli@cgfl.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Principal Investigator Name
Elvire PONS-TOSTIVINT
Principal Investigator Email
Jeanne.chen@chu-nantes.fr
Contact Person Name
Elvire PONS-TOSTIVINT
Contact Person Email
Jeanne.chen@chu-nantes.fr
Site Name
Institut Bergonie
Principal Investigator Name
Sophie COUSIN
Principal Investigator Email
s.cousin@bordeaux-unicancer.fr
Contact Person Name
Sophie COUSIN
Contact Person Email
s.cousin@bordeaux-unicancer.fr
Site Name
Institut Curie
Principal Investigator Name
Pauline DU RUSQUEC
Principal Investigator Email
Pauline.durusquec@curie.fr
Contact Person Name
Pauline DU RUSQUEC
Contact Person Email
Pauline.durusquec@curie.fr
Site Name
Hospices Civils De Lyon
Principal Investigator Name
Michael DURUISSEAUX
Principal Investigator Email
Michael.duruisseaux@chu-lyon.fr
Contact Person Name
Michael DURUISSEAUX
Site Name
Oncopole Claudius Regaud
Principal Investigator Name
Audrey RABEAU
Principal Investigator Email
Rabeau.audrey@iuct-ocopole.fr
Contact Person Name
Audrey RABEAU
Contact Person Email
Rabeau.audrey@iuct-ocopole.fr
Site Name
Centre Francois Baclesse
Principal Investigator Name
Hubert CURCIO
Principal Investigator Email
h.curcio@baclesse.unicancer.fr
Contact Person Name
Hubert CURCIO
Contact Person Email
h.curcio@baclesse.unicancer.fr
Site Name
Assistance Publique Hopitaux De Paris
Principal Investigator Name
Jacques Cadranel
Principal Investigator Email
Jacques.cadranel@aphp.fr
Contact Person Name
Jacques Cadranel
Contact Person Email
Jacques.cadranel@aphp.fr
Site Name
Institut Gustave Roussy
Principal Investigator Name
Anas GAZZAH
Principal Investigator Email
anas.gazzah@gustaveroussy.fr
Contact Person Name
Anas GAZZAH
Contact Person Email
anas.gazzah@gustaveroussy.fr
Site Name
Hopital Ambroise Pare
Department Name
Department of Respiratory Diseases and Thoracic-Oncology
Principal Investigator Name
Pierre Giroux-Leprieur
Principal Investigator Email
Etienne.giroux-leprieur@aphp.fr
Contact Person Name
Pierre Giroux-Leprieur
Site Name
Centre Hospitalier Universitaire De Lille
Principal Investigator Name
Alexis CORTOT
Principal Investigator Email
Alexis.cortot@chru-lille.fr
Contact Person Name
Alexis CORTOT
Contact Person Email
Alexis.cortot@chru-lille.fr

Austria

Earliest CTIS Part Ii Submission Date
19-09-2025
Latest Decision Or Authorization Date
22-09-2025
Processing Time Days
3
Number Of Sites
2
Number Of Participants
5

Sites

Site Name
Stadt Wien Wiener Gesundheitsverbund
Department Name
c/o Klinik Floridsdorf Abteilung für Innere Medizin und Lungenforschung
Principal Investigator Name
Maximilian Hochmair
Principal Investigator Email
maximilian.hochmair@gesundheitsverbund.at
Contact Person Name
Maximilian Hochmair
Site Name
Noe LGA Gesundheit Region Mitte GmbH
Department Name
Klinische Abteilung für Innere Medizin 1
Principal Investigator Name
Martin Wiesholzer
Principal Investigator Email
martin.wiesholzer@stpoelten.lknoe.at
Contact Person Name
Martin Wiesholzer

Greece

Earliest CTIS Part Ii Submission Date
26-08-2025
Latest Decision Or Authorization Date
25-09-2025
Processing Time Days
30
Number Of Sites
2
Number Of Participants
5

Sites

Site Name
Thoracic General Hospital Of Athens I Sotiria
Department Name
Oncology Unit, 3'd Department of Ιnternal Medicine and Laboratory
Principal Investigator Name
Konstantinos Syrigos
Principal Investigator Email
ksyrigos.trials@gmail.com
Contact Person Name
Konstantinos Syrigos
Contact Person Email
ksyrigos.trials@gmail.com
Site Name
Henry Dunant Hospital Center
Department Name
D’ Oncology clinic & Clinical Trials Unit
Principal Investigator Name
Ioannis Mountzios
Principal Investigator Email
gmountzios@gmail.com
Contact Person Name
Ioannis Mountzios
Contact Person Email
gmountzios@gmail.com

Netherlands

Earliest CTIS Part Ii Submission Date
15-09-2025
Latest Decision Or Authorization Date
29-09-2025
Processing Time Days
14
Number Of Sites
3
Number Of Participants
8

Sites

Site Name
Universitair Medisch Centrum Utrecht
Department Name
Medical Oncology
Principal Investigator Name
Hilde Nienhuis
Principal Investigator Email
oncostudies@umcutrecht.nl
Contact Person Name
Hilde Nienhuis
Contact Person Email
oncostudies@umcutrecht.nl
Site Name
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Department Name
Clinical Research Unit
Principal Investigator Name
Gerrina Ruiter
Principal Investigator Email
cpm-cru@nki.nl
Contact Person Name
Gerrina Ruiter
Contact Person Email
cpm-cru@nki.nl
Site Name
Leids Universitair Medisch Centrum (LUMC)
Department Name
Department of Pulmonary Diseases
Principal Investigator Name
Egbert F. Smit
Principal Investigator Email
e.f.smit@lumc.nl
Contact Person Name
Egbert F. Smit
Contact Person Email
e.f.smit@lumc.nl

Italy

Earliest CTIS Part Ii Submission Date
29-08-2025
Latest Decision Or Authorization Date
24-09-2025
Processing Time Days
26
Number Of Sites
4
Number Of Participants
9

Sites

Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
Unità Clinica Fase 1 – UO Oncologia di Ravenna
Principal Investigator Name
Manolo D’Arcangelo
Principal Investigator Email
manolo.darcangelo@auslromagna.it
Contact Person Name
Manolo D’Arcangelo
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Unità Operativa Complessa Fase 1
Principal Investigator Name
Gennaro Daniele
Principal Investigator Email
gennaro.daniele@policlinicogemelli.it
Contact Person Name
Gennaro Daniele
Site Name
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Department Name
Unità: SSD Oncologia polmonare-A.O.U. San Luigi Gonzaga - Orbassano
Principal Investigator Name
Silvia Novello
Principal Investigator Email
silvia.novello@unito.it
Contact Person Name
Silvia Novello
Contact Person Email
silvia.novello@unito.it
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
SC Oncologia Falck
Principal Investigator Name
Salvatore Siena
Principal Investigator Email
salvatore.siena@ospedaleniguarda.it
Contact Person Name
Salvatore Siena

Germany

Earliest CTIS Part Ii Submission Date
29-08-2025
Latest Decision Or Authorization Date
24-09-2025
Processing Time Days
26
Number Of Sites
4
Number Of Participants
8

Sites

Site Name
Goethe University Frankfurt
Department Name
Medizinische Klinik II
Principal Investigator Name
Martin Sebastian
Principal Investigator Email
sebastian@med.uni-frankfurt.de
Contact Person Name
Martin Sebastian
Contact Person Email
sebastian@med.uni-frankfurt.de
Site Name
Technische Universitaet Dresden
Department Name
Medizinische Klinik und Poliklinik I
Principal Investigator Name
Martin Wermke
Principal Investigator Email
martin.wermke@uniklinikum-dresden.de
Contact Person Name
Martin Wermke
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Medizinische Klinik mit Schwerpunkt Onkologie, Hämatologie und Tumorimmunologie
Principal Investigator Name
Damian T. Rieke Lang
Principal Investigator Email
damian.rieke@charite.de
Contact Person Name
Damian T. Rieke Lang
Contact Person Email
damian.rieke@charite.de
Site Name
University Hospital Cologne AöR
Department Name
Klinik I für Innere Medizin
Principal Investigator Name
Jürgen Wolf
Principal Investigator Email
juergen.wolf@uk-koeln.de
Contact Person Name
Jürgen Wolf
Contact Person Email
juergen.wolf@uk-koeln.de

Sponsor

Primary sponsor

Full Name
Revolution Medicines Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
PPD Development LP
Responsibilities
Contract Research Organization, Clinical Database Management, Pharmacovigilance services.
Name
PPD Global Ltd.
Responsibilities
Collect and read ECG scans; other monitoring/operational roles
Name
Icon Clinical Research LLC
Responsibilities
Collect and read ECG scans; clinical operational support
Name
PPD Denmark Filial Af PPD Scandinavia AB Sverige
Responsibilities
Monitoring; collect and read ECG scans

Third parties

  • {"country":"United States","full_name":"Myonex LLC","duties_or_roles":"Clinical Supply","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Electronic drug diaries","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient travel & Reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Alturas Analytics Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Tempus AI Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Atreo Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Greece","full_name":"PPD Global Ltd.","duties_or_roles":"Collect and read ECG scans; Clinical Supply/monitoring roles (codes present)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Propharma Group LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Icon Clinical Research LLC","duties_or_roles":"Collect and read ECG scans","organisation_type":"Pharmaceutical company"}
  • {"country":"Denmark","full_name":"PPD Denmark Filial Af PPD Scandinavia AB Sverige","duties_or_roles":"Monitor; Collect and read ECG scans","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"Contract Research Organization, Clinical Database Management, Pharmacovigilance services.","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"ctDNA Analysis","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United Kingdom","full_name":"Primevigilance Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Aperio Clinical Outcomes LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Adaptive Biotechnologies Corp.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Discovery Life Sciences LLC","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Sherpa Clinical Packaging LLC","duties_or_roles":"Collect and read ECG scans","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Edetek Inc.","duties_or_roles":"Stats Programing","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"Central Imaging","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Atreo Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
RMC-9805
Active Substance
(2S)-2-CYCLOPENTYL-2-[(5S)-2-[(2R,3R)-3-CYCLOPROPYL-1-METHYLAZIRIDINE-2-CARBONYL]-2,7-DIAZASPIRO[4.4]NONAN-7-YL]-N-[(6S,8S,14S)-21-[5-(4-CYCLOPROPYLPIPERAZIN-1-YL)-2-[(1S)-1-METHOXYETHYL]PYRIDIN-3-YL]-18,18-DIMETHYL-9,15-DIOXO-22-(2,2,2-TRIFLUOROETHYL)-5,16-DIOXA-2,10,22,28-TETRAZAPENTACYCLO[18.5.2.12,6.110,14.023,27]NONACOSA-1(26),20,23(27),24-TETRAEN-8-YL]ACETAMIDE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Maximum Dose
1200 mg

Related trials

Other published trials that may interest you.