Beamion LUNG-1: A study to test different doses of zongertinib in people with different types of advanced cancer (solid tumours with changes in the HER2 gene)

Start 27 Jul 2021 · Status Ongoing, recruiting · 8 EU/EEA countries · 26 sites · Protocol 1479-0001

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - First administration to humans

Status Ongoing, recruiting

Participants planned 592

Countries 8

Sites 26

Solid tumours with HER2 aberrations

Key facts

Sponsor: Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Neoplasms [C04]
Trial duration: 27 Jul 2021 → ongoing
Decision date (initial): 2024-09-26
Transition trial: Yes
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No

External identifiers

EU CT number: 2024-511246-39-00
EudraCT number: 2020-004563-47
WHO UTN: U1111-1312-5969

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Solid tumours with HER2 aberrations

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Boehringer Ingelheim International GmbH

Sponsor organisation: Boehringer Ingelheim International GmbH
Address: Binger Strasse 173
City: Ingelheim Am Rhein
Postcode: 55216
Country: Germany

Scientific contact point

Organisation: Boehringer Ingelheim International GmbH
Contact name: CT Disclosure & Data Transparency

Public contact point

Organisation: Boehringer Ingelheim International GmbH
Contact name: CT Disclosure & Data Transparency

Boehringer Ingelheim Espana S.A.

Sponsor organisation: Boehringer Ingelheim Espana S.A.
Address: Carrer Prat De La Riba 50, Sant Cugat Del Valles Sant Cugat Del Valles
City: Barcelona
Postcode: 08174
Country: Spain

Locations

8 EU/EEA countries · 26 investigational sites

By country

Country	MS status	Planned subjects	Sites
Belgium	Ongoing, recruiting	2	1
France	Ongoing, recruiting	31	6
Germany	Ongoing, recruiting	20	5
Italy	Ongoing, recruiting	2	3
Netherlands	Ongoing, recruiting	71	2
Portugal	Ongoing, recruiting	1	2
Spain	Ongoing, recruiting	33	6
Sweden	Ongoing, recruiting	2	1
Rest of world Korea, Republic of, Australia, United States, United Kingdom, Japan, Israel, China, Singapore, Hong Kong	—	430	—

Investigational sites

Belgium

1 site · Ongoing, recruiting

Institut Jules Bordet

Oncology department, Mijlenmeersstraat 90, 1070, Anderlecht

France

6 sites · Ongoing, recruiting

Institut Curie

Oncologie Médicale, 26 Rue D Ulm, 75005, Paris

Centre Hospitalier Regional De Marseille

Unité de Phase I Oncologie labélisée CLIP, 264 Rue Saint Pierre, 13005, Marseille

Institut Gustave Roussy

Service d’Onco-Pneumologie, 39 Rue Camille Desmoulins, 94805, Villejuif Cedex

Centre Leon Berard

Oncologie Médicale, 28 Rue Laennec, 69008, Lyon

Hospices Civils De Lyon

Plateforme de traitements oncologiques, 59 Boulevard Pinel, 69500, Bron

Centre Hospitalier Universitaire De Rennes

Unité d'Investigation Clinique, 2 Rue Henri Le Guilloux, 35000, Rennes

Germany

5 sites · Ongoing, recruiting

Universitaetsklinikum Augsburg

II. Medizinische Klinik, Stenglinstrasse 2, Kriegshaber, Augsburg

Pius-Hospital Oldenburg

Klinik für Hämatologie und Onkologie, Georgstrasse 12, Innenstadt, Oldenburg

Justus-Liebig-Universitaet Giessen

Universitätsklinikum Gießen und Marburg GmbH, Gaffkystrasse 5, 35392, Giessen

University Hospital Cologne AöR

Klinik I für Innere Medizin, Kerpener Strasse 62, Lindenthal, Cologne

Technische Universitaet Dresden

Medizinische Klinik und Poliklinik I, Fetscherstrasse 74, Johannstadt-Nord, Dresden

Italy

3 sites · Ongoing, recruiting

Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS

Oncologia Medica, Strada Provinciale 142 Orba Km 3,95, 10060, Candiolo

IRCCS Istituto Nazionale Tumori Fondazione Pascale

Sc Ematologia Oncologia, Via Mariano Semmola 52, 80131, Naples

Azienda Ospedaliero Universitaria Parma

U. O. di Oncologia Medica, Viale Antonio Gramsci 14, 43126, Parma

Netherlands

2 sites · Ongoing, recruiting

Leids Universitair Medisch Centrum (LUMC)

Longziekten, Albinusdreef 2, 2333 ZA, Leiden

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Klinische Farmacologie, Plesmanlaan 121, 1066 CX, Amsterdam

Portugal

2 sites · Ongoing, recruiting

Hospital Cuf Descobertas S.A.

Serviço de Oncologia, Rua Mario Botas 1, 1998-018, Lisbon

Hospital CUF Porto S.A.

Serviço Pneumologia, Estrada Da Circunvalacao N 14341, 4100-180, Porto

Spain

6 sites · Ongoing, recruiting

Hospital General Universitario Gregorio Maranon

Thoracic Oncology, Head & Neck and Sarcoma Unit, Calle Del Doctor Esquerdo 46, 28007, Madrid

Hospital Clinico Universitario De Valencia

Servicio de Hematología y Oncología, Avenida Blasco Ibanez 17, 46010, Valencia

Hospital Universitario Virgen De La Victoria

UGC Oncología Intercentros, Calle Del Arroyo Teatinos S/N, 29010, Malaga

Hospital Universitario 12 De Octubre

Servicio de Oncología, Avenida De Cordoba Sn, 28041, Madrid

Hospital Universitari Vall D Hebron

Servicio de Oncología Médica, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona

Institut Catala D'oncologia

Department of Medical Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat

Sweden