Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruiting
Participants planned
162
Countries
4
Sites
10
Non-Small Cell Lung Cancer (NSCLC) harboring activating EGFR or HER2 kinase domain mutations
Key facts
- Sponsor
- Arrivent Biopharma Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 18 Oct 2022 → ongoing
- Decision date (initial)
- 2024-07-17
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-508349-42-00
- EudraCT number
- 2021-005831-22
- ClinicalTrials.gov
- NCT05364073
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Non-Small Cell Lung Cancer (NSCLC) harboring activating EGFR or HER2 kinase domain mutations
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 24.0 | LLT | 10084785 | HER2 positive non-small cell lung cancer | 100000004848 |
| 27.0 | PT | 10059515 | Non-small cell lung cancer metastatic | 100000004864 |
| 24.0 | PT | 10084787 | HER2 mutant non-small cell lung cancer | 100000004864 |
| 21.1 | LLT | 10075656 | EGFR exon 19 deletion | 10018065 |
| 20.0 | SOC | 10038738 | Respiratory thoracic and mediastinal disorders | 13 |
| 21.1 | PT | 10061873 | Non-small cell lung cancer | 100000004864 |
| 22.0 | LLT | 10075657 | Point mutation in exon 21 (L858R) | 10018065 |
| 27.0 | LLT | 10066490 | Progression of non-small cell lung cancer | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Arrivent Biopharma Inc.
- Sponsor organisation
- Arrivent Biopharma Inc.
- Address
- 18 Campus Boulevard Suite 100
- City
- Newtown Square
- Postcode
- 19073-3240
- Country
- United States
Scientific contact point
- Organisation
- Arrivent Biopharma Inc.
- Contact name
- Furmonertinib Study info Help Desk
Public contact point
- Organisation
- Arrivent Biopharma Inc.
- Contact name
- Furmonertinib Study info Help Desk
Locations
4 EU/EEA countries · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 7 | 3 |
| Italy | Ended | 1 | 2 |
| Netherlands | Ongoing, recruitment ended | 1 | 1 |
| Spain | Ongoing, recruitment ended | 23 | 4 |
| Rest of world
Australia, Korea, Republic of, United States, Canada, Japan, United Kingdom
|
— | 130 | — |
Investigational sites
Oncopole Claudius Regaud
Oncologie Medicale, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Centre Leon Berard
Oncologie Medicale, 28 Rue Laennec, 69008, Lyon
Institut Gustave Roussy
Medecine Oncologique, 114 Rue Edouard Vaillant, 94800, Villejuif
Istituto Europeo Di Oncologia S.r.l.
Oncology, Via Giuseppe Ripamonti 435, 20141, Milan
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Oncology, Via Piero Maroncelli 40, 47014, Meldola
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
MOD, Thoracic-Oncology, Plesmanlaan 121, 1066 CX, Amsterdam
Hospital Universitario Y Politecnico La Fe
Oncology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario Hm Sanchinarro
START Madrid - CIOCC, Calle Ona 10, 28050, Madrid
Hospital Universitari Vall D Hebron
Thoracic and H&N Oncology Unit, Oncology department, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
MD Anderson Cancer Center
Oncology, Calle De Arturo Soria Nº 270, 28033, Madrid
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2023-05-26 | 2023-06-15 | 2024-07-23 | ||
| Italy | 2024-03-28 | 2024-11-22 | |||
| Netherlands | 2023-04-13 | 2023-09-12 | 2024-07-23 | ||
| Spain | 2022-10-18 | 2023-10-20 | 2024-07-23 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-27 | Spain | Acceptable with conditions 2024-07-11
|
2024-07-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-21 | Spain | Acceptable 2025-02-25
|
2025-02-25 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-05-23 | Spain | Acceptable | 2025-06-04 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-02-19 | Spain | Acceptable 2026-04-20
|
2026-04-22 |