Clinical trial • Phase III • Oncology
N-[2-[2-(DIMETHYLAMINO)ETHYL-METHYLAMINO]-5-[[4-(1-METHYLINDOL-3-YL)PYRIMIDIN-2-YL]AMINO]-6-(2,2,2-TRIFLUOROETHOXY)PYRIDIN-3-YL]PROP-2-ENAMIDE for Non-small cell lung cancer | Advanced or metastatic non-small cell lung cancer with EGFR PACC uncommon mutations
Phase III trial of N-[2-[2-(DIMETHYLAMINO)ETHYL-METHYLAMINO]-5-[[4-(1-METHYLINDOL-3-YL)PYRIMIDIN-2-YL]AMINO]-6-(2,2,2-TRIFLUOROETHOXY)PYRIDIN-3-YL]PROP-2-…
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Non-small cell lung cancer | Advanced or metastatic non-small cell lung cancer with EGFR PACC uncommon mutations
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 15-08-2025
- First CTIS Authorization Date
- 10-12-2025
Trial design
Randomised, open-label, investigator's choice comparator arms: osimertinib 80 mg qd; afatinib 40 mg qd-controlled Phase III trial across 22 sites in Italy, Greece, France and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Investigator's choice comparator arms: Osimertinib 80 mg QD; Afatinib 40 mg QD
- Target Sample Size
- 352
Eligibility
Recruits 352 Vulnerable population flag selected. Country-specific subject information and informed consent forms are provided (examples: L1_*_SIS-ICF_Main, L1_*_SIS-ICF_Pregnant Participant, L1_*_SIS-ICF_Pregnant Partner) in multiple languages (Italian, Greek, French, Spanish). Consent is obtained from participants via these SIS-ICF forms; no specific assent or parental consent procedures for minors are described in the provided materials..
- Vulnerable Population
- Vulnerable population flag selected. Country-specific subject information and informed consent forms are provided (examples: L1_*_SIS-ICF_Main, L1_*_SIS-ICF_Pregnant Participant, L1_*_SIS-ICF_Pregnant Partner) in multiple languages (Italian, Greek, French, Spanish). Consent is obtained from participants via these SIS-ICF forms; no specific assent or parental consent procedures for minors are described in the provided materials.
Inclusion criteria
- {"criterion_text":"- 1. Histologically or cytologically documented, locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy.\n- 2. Documented results of the presence of an Epidermal Growth Factor Receptor (EGFR) PACC mutation in tumor tissue or blood from local testing.\n- 3. No prior systemic anticancer therapy regimens received for locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) including prior treatment with any Epidermal Growth Factor Receptor (EGFR)-targeting agents (e.g., previous (EGFR) TKIs, monoclonal antibodies, or bispecific antibodies).\n- 4. Patients who have received prior neo-adjuvant and/or adjuvant chemotherapy, immunotherapy, or chemo radiotherapy for non-metastatic disease must have experienced a treatment free interval of at least 12 months.\n- 5. Patients with asymptomatic CNS metastases are eligible"}
Exclusion criteria
- {"criterion_text":"- 1. Have NSCLC with any of the following EGFR mutations: exon 19 deletion, L858R, or C797S\n- 2. Have had prior treatment with EGFR-targeted agents (eg, EGFR-TKIs, EGFR-targeted proteolysis-targeting chimeras [PROTACs], monoclonal antibodies, or bispecific antibodies)\n- 3. Have had prior treatment with any systemic anti-cancer therapy for locally advanced or metastatic NSCLC not amenable to curative surgery or radiation, including chemotherapy, biologic therapy, immunotherapy, or any investigational drug\n- 4. Have had previous interstitial lung disease (ILD), including drug-induced ILD, or active ILD/active radiation pneumonitis\n- 5. Have a mean resting corrected QT interval (QTc) > 470 ms, obtained from triplicate electrocardiograms (ECGs) with QT interval corrected by Fridericia’s method (QTcF)"}
Endpoints
Primary endpoints
- {"endpoint_text":"- 1. Progression Free Survival (PFS) determined by blinded independent central review (BICR)","definition_or_measurement_approach":"PFS determined by blinded independent central review (BICR)"}
- {"endpoint_text":"- 2. Confirmed overall response rate (ORR) as determined by BICR","definition_or_measurement_approach":"Confirmed ORR as determined by blinded independent central review (BICR)"}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 352
- Recruitment Window Months
- 57
- Consent Approach
- Informed consent is obtained from participants using subject information sheets and informed consent forms (SIS-ICF) provided in country-specific languages (examples: Italian, Greek, French, Spanish). Country-specific SIS-ICF variants include forms for pregnant participants and pregnant partners and optional biopsy/data privacy modules. No pediatric assent/parental consent procedures are described in the provided materials.
Methods
- Italy: Site-based recruitment per K1_IT_Recruitment Procedure using HCP letters, HCP factsheets, brochures, IE cards and participant-facing materials in Italian; appointment reminders and thank you letters.
- Greece: Site-based recruitment per K1_EL_Recruitment Procedure using Greek-language HCP letters, HCP factsheets, brochures, IE cards and participant-facing materials; appointment reminders and thank you letters.
- France: Recruitment per K1_FR_Recruitment Procedure (Bilingual) including SCOUT recruitment services (SCOUT brochure, SCOUT email communication), HCP letters and factsheets, participant brochures and IE cards in French.
- Spain: Site-based recruitment per K1_ES_Recruitment Procedure using Spanish-language HCP letters, HCP factsheets, brochures, IE cards and participant-facing materials.
Geography
- Total Number Of Sites
- 22
- Total Number Of Participants
- 36
Italy
- Earliest CTIS Part Ii Submission Date
- 24-10-2025
- Latest Decision Or Authorization Date
- 10-12-2025
- Processing Time Days
- 47
- Number Of Sites
- 3
- Number Of Participants
- 8
Sites
- Site Name
- Istituto Europeo Di Oncologia S.r.l.
- Department Name
- Thoracic Oncology Division
- Principal Investigator Name
- Antonio Passaro
- Principal Investigator Email
- Antonio.passaro@ieo.it
- Contact Person Name
- Antonio Passaro
- Contact Person Email
- Antonio.passaro@ieo.it
- Site Name
- Centro Di Riferimento Oncologico Di Aviano
- Department Name
- SOC Oncologia Medica
- Principal Investigator Name
- Alessandra Bearz
- Principal Investigator Email
- abearz@cro.it
- Contact Person Name
- Alessandra Bearz
- Contact Person Email
- abearz@cro.it
- Site Name
- Universita' Degli Studi Di Modena E Reggio Emilia
- Department Name
- SSD Oncologia
- Principal Investigator Name
- Federica Bertolini
- Principal Investigator Email
- Bertolini.federica@aou.mo.it
- Contact Person Name
- Federica Bertolini
- Contact Person Email
- Bertolini.federica@aou.mo.it
Greece
- Earliest CTIS Part Ii Submission Date
- 05-09-2025
- Latest Decision Or Authorization Date
- 11-12-2025
- Processing Time Days
- 97
- Number Of Sites
- 4
- Number Of Participants
- 8
Sites
- Site Name
- Thoracic General Hospital Of Athens I Sotiria
- Department Name
- Oncology Unit, 3rd Department of Internal Medicine andLaboratory
- 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
- University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
- Department Name
- 2nd Propaedeutic Internal Medicine Clinic & Research Unit - Oncology Unit
- Principal Investigator Name
- Amanda Psyrri
- Principal Investigator Email
- psyrri237@yahoo.com
- Contact Person Name
- Amanda Psyrri
- Contact Person Email
- psyrri237@yahoo.com
- Site Name
- Henry Dunant Hospital Center
- Department Name
- 4th Oncology Department and 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
- Site Name
- Athens Medical Center S.A.
- Department Name
- 4th Department of Medical Oncology
- Principal Investigator Name
- Ippokratis Korantzis
- Principal Investigator Email
- ippokratis.korantzis@gmail.com
- Contact Person Name
- Ippokratis Korantzis
- Contact Person Email
- ippokratis.korantzis@gmail.com
France
- Earliest CTIS Part Ii Submission Date
- 27-11-2025
- Latest Decision Or Authorization Date
- 15-12-2025
- Processing Time Days
- 18
- Number Of Sites
- 9
- Number Of Participants
- 14
Sites
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Pneumology
- Principal Investigator Name
- Julien Mazieres
- Principal Investigator Email
- mazieres.j@chu-toulouse.fr
- Contact Person Name
- Julien Mazieres
- Contact Person Email
- mazieres.j@chu-toulouse.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Pulmonology
- Principal Investigator Name
- Michael Duruisseaux
- Principal Investigator Email
- michael.duruisseaux@chu-lyon.fr
- Contact Person Name
- Michael Duruisseaux
- Contact Person Email
- michael.duruisseaux@chu-lyon.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Oncology Medical Department – Oncology Thoracic Unit
- Principal Investigator Name
- Elvire Pons-Tostivint
- Principal Investigator Email
- elvire.pons@chu-nantes.fr
- Contact Person Name
- Elvire Pons-Tostivint
- Contact Person Email
- elvire.pons@chu-nantes.fr
- Site Name
- Centre Leon Berard
- Department Name
- Medical Oncology
- Principal Investigator Name
- Maurice Perol
- Principal Investigator Email
- maurice.perol@lyon.unicancer.fr
- Contact Person Name
- Maurice Perol
- Contact Person Email
- maurice.perol@lyon.unicancer.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Thoracic Oncology
- Principal Investigator Name
- Laurent Greillier
- Principal Investigator Email
- laurent.greillier@ap-hm.fr
- Contact Person Name
- Laurent Greillier
- Contact Person Email
- laurent.greillier@ap-hm.fr
- Site Name
- Hospices Civils De Lyon (Lyon Cedex 04)
- Department Name
- Pulmonology
- Principal Investigator Name
- Michael Duruisseaux
- Principal Investigator Email
- michael.duruisseaux@chu-lyon.fr
- Contact Person Name
- Michael Duruisseaux
- Contact Person Email
- michael.duruisseaux@chu-lyon.fr
- Site Name
- Centre Francois Baclesse
- Department Name
- Department of Pneumology
- 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
- Hospices Civils De Lyon (Pierre Benite)
- Department Name
- Pulmonology
- Principal Investigator Name
- Michael Duruisseaux
- Principal Investigator Email
- michael.duruisseaux@chu-lyon.fr
- Contact Person Name
- Michael Duruisseaux
- Contact Person Email
- michael.duruisseaux@chu-lyon.fr
- Site Name
- Institut De Cancerologie De L Ouest
- Department Name
- Medical Oncology
- Principal Investigator Name
- Ludovic Doucet
- Principal Investigator Email
- ludovic.doucet@ico.unicancer.fr
- Contact Person Name
- Ludovic Doucet
- Contact Person Email
- ludovic.doucet@ico.unicancer.fr
Spain
- Earliest CTIS Part Ii Submission Date
- 04-11-2025
- Latest Decision Or Authorization Date
- 12-12-2025
- Processing Time Days
- 38
- Number Of Sites
- 6
- Number Of Participants
- 6
Sites
- Site Name
- Hospital Universitario Central De Asturias
- Department Name
- Oncology
- Principal Investigator Name
- Noemi Villanueva Palicio
- Principal Investigator Email
- noemivipa@gmail.com
- Contact Person Name
- Noemi Villanueva Palicio
- Contact Person Email
- noemivipa@gmail.com
- Site Name
- Hospital Quironsalud Malaga
- Department Name
- Oncology
- Principal Investigator Name
- Manuel Cobo Dols
- Principal Investigator Email
- manuelcobodols@yahoo.es
- Contact Person Name
- Manuel Cobo Dols
- Contact Person Email
- manuelcobodols@yahoo.es
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Oncology
- Principal Investigator Name
- Oscar José Juan Vidal
- Principal Investigator Email
- ojjuanv@seom.org
- Contact Person Name
- Oscar José Juan Vidal
- Contact Person Email
- ojjuanv@seom.org
- Site Name
- University Hospital Son Espases
- Department Name
- Oncology
- Principal Investigator Name
- Raquel Marsé Fabregat
- Principal Investigator Email
- raquel.marse@ssib.es
- Contact Person Name
- Raquel Marsé Fabregat
- Contact Person Email
- raquel.marse@ssib.es
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Oncology
- Principal Investigator Name
- Noemí Reguart Aransay
- Principal Investigator Email
- nreguart@clinic.cat
- Contact Person Name
- Noemí Reguart Aransay
- Contact Person Email
- nreguart@clinic.cat
- Site Name
- Hospital Universitario Y Politecnico La Fe (additional site entry)
- Department Name
- Oncology
- Principal Investigator Name
- Oscar José Juan Vidal
- Principal Investigator Email
- ojjuanv@seom.org
- Contact Person Name
- Oscar José Juan Vidal
- Contact Person Email
- ojjuanv@seom.org
Sponsor
Primary sponsor
- Full Name
- Arrivent Biopharma Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Icon Clinical Research Limited
- Responsibilities
- Codes [1,10,11,12,13,15]; responsibilities include storage of laboratory samples, medical image and ECG analysis/review, recruitment services (as listed)
- Name
- PRA Hellas CRO A.E.
- Responsibilities
- sponsorDuties code 12
- Name
- Imperial Clinical Research Services International Ltd.
- Responsibilities
- sponsorDuties code 15 (printing)
- Name
- Scout Clinical
- Responsibilities
- sponsorDuties code 15 (patient reimbursement) and recruitment support
Third parties
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: [7]; contact Joseph.Palladino@3ds.com","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"sponsorDuties code 15 (patient reimbursement)","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Imperial Clinical Research Services International Ltd.","duties_or_roles":"sponsorDuties code 15 (printing)","organisation_type":"Pharmaceutical company"}
- {"country":"Greece","full_name":"PRA Hellas CRO A.E.","duties_or_roles":"sponsorDuties code 12","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Catalent Germany Schorndorf GmbH","duties_or_roles":"sponsorDuties code 14","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties codes [1,10,11,12,13,15]; text includes storage of laboratory samples, Medical image and ECG analysis/ review, recruitment services; contact ICONRegulatoryCTIS@iconplc.com","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"sponsorDuties code 15 (eCoA)","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Furmonertinib
- Active Substance
- N-[2-[2-(DIMETHYLAMINO)ETHYL-METHYLAMINO]-5-[[4-(1-METHYLINDOL-3-YL)PYRIMIDIN-2-YL]AMINO]-6-(2,2,2-TRIFLUOROETHOXY)PYRIDIN-3-YL]PROP-2-ENAMIDE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Investigational (test product, part1 role 'Test')
- Starting Dose
- 240 mg
- Dose Levels
- 240 mg (QD)
- Frequency
- QD
- Maximum Dose
- 240 mg daily
- Investigational Product Name
- Osimertinib
- Active Substance
- OSIMERTINIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Marketing authorisation referenced (EU/1/16/1086/... indicated in product data)
- Starting Dose
- 80 mg
- Dose Levels
- 80 mg (QD)
- Frequency
- QD
- Maximum Dose
- 80 mg daily
- Investigational Product Name
- Afatinib
- Active Substance
- AFATINIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Marketing authorisation referenced (EU/1/13/879/... indicated in product data)
- Starting Dose
- 40 mg
- Dose Levels
- 40 mg (QD)
- Frequency
- QD
- Maximum Dose
- 40 mg daily
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