Clinical trial • Phase III • Oncology

ATEZOLIZUMAB for Non-small cell lung cancer

Phase III trial of ATEZOLIZUMAB for Non-small cell lung cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Non-small cell lung cancer
Trial Stage
Phase III
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
20-03-2024
First CTIS Authorization Date
26-04-2024

Trial design

Randomised, open-label, arm a: atezolizumab (tecentriq) (iv infusion) — investigational product 'tecentriq' (product information lists maxdailydoseamount 1200 mg); arm b: best supportive care (comparator). scheduling details not specified in arm listing.-controlled Phase III trial in Romania, Germany, France and others.

Randomised
Yes
Open Label
Yes
Comparator
Arm A: Atezolizumab (Tecentriq) (IV infusion) — investigational product 'Tecentriq' (product information lists maxDailyDoseAmount 1200 mg); Arm B: Best supportive care (comparator). Scheduling details not specified in Arm listing.
Biomarker Stratified
True, PD-L1 assessed by SP263 IHC; subpopulations/strata defined as ≥1% TC expression and also analyses in ≥50% TC expression
Target Sample Size
819

Eligibility

Recruits 819 The record indicates isVulnerablePopulationSelected = true. Exclusion criterion specifies: "Illness or condition that may interfere with a participant's capacity to understand, follow, and/or comply with study procedures" (capacity requirement). Subject information and informed consent forms (Main ICF and country-specific ICFs) are provided (multiple languages and country-specific ICF documents listed). No mention of assent or enrolment of minors is provided in the available data..

Pregnancy Exclusion
Pregnant and lactating women
Vulnerable Population
The record indicates isVulnerablePopulationSelected = true. Exclusion criterion specifies: "Illness or condition that may interfere with a participant's capacity to understand, follow, and/or comply with study procedures" (capacity requirement). Subject information and informed consent forms (Main ICF and country-specific ICFs) are provided (multiple languages and country-specific ICF documents listed). No mention of assent or enrolment of minors is provided in the available data.

Inclusion criteria

  • {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1"}
  • {"criterion_text":"- Histological or cytological diagnosis of Stage IB (tumors greater than or equal to [>/=] 4 centimeters [cm])-IIIA (T2-3 N0, T1-3 N1, T1-3 N2, T4 N0-1) NSCLC (per the Union Internationale Contre le Cancer staging system (UICC)/American Joint Committee on Cancer staging system (AJCC) staging system, 7th edition; Detterbeck et al. 2009)"}
  • {"criterion_text":"- Participants must have had complete resection of NSCLC 4-12 weeks (>/=28 days and less than or equal to [</=] 84 days) prior to enrollment and must be adequately recovered from surgery"}
  • {"criterion_text":"- If mediastinoscopy was not performed preoperatively, it is expected that, at a minimum, mediastinal lymph node systematic sampling will have occurred. Systematic sampling is defined as removal of at least one representative lymph node at specified levels. MLND entails resection of all lymph nodes at those same levels. For a right thoracotomy, sampling or MLND is required at levels 4 and 7 and for a left thoracotomy, levels 5 and/or 6 and 7. Exceptions will be granted if there is clear documentation in the operative report or in a separately submitted addendum by the surgeon of exploration of the required lymph node areas, the participant will be considered eligible if no lymph nodes are found in those areas; if participants have documented N2 disease in one level (per the UICC/AJCC staging system, 7th edition; Detterbeck et al. 2009), not all levels need to be sampled; if the preoperative staging imaging results (contrast computed tomography [CT] and positron emission tomography [PET] scans) do not suggest evidence of disease in the mediastinum, the participant will be considered eligible if N2 nodal sampling is not performed per surgeon's decision"}
  • {"criterion_text":"- Eligible to receive a cisplatin-based chemotherapy regimen"}
  • {"criterion_text":"- Adequate hematologic and end-organ function"}

Exclusion criteria

  • {"criterion_text":"- Illness or condition that may interfere with a participant's capacity to understand, follow, and/or comply with study procedures"}
  • {"criterion_text":"- Pregnant and lactating women"}
  • {"criterion_text":"- Treatment with prior systemic chemotherapy: Chemotherapy for early stage of malignancy with curative intent, provided that the last dose received was more than 5 years prior to enrollment and low-dose chemotherapy for non-malignant conditions may be allowed upon approval by the Medical Monitor"}
  • {"criterion_text":"- Hormonal cancer therapy or radiation therapy as prior cancer treatment within 5 years before enrollment"}
  • {"criterion_text":"- Treatment with any other investigational agent with therapeutic intent within 28 days prior to enrollment"}
  • {"criterion_text":"- Participants with hearing impairment"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 1. DFS, defined as the time from randomization to the date of occurrence of any of the following, whichever occurs first: First recurrence of NSCLC, as determined by the investigator after an integrated assessment of radiographic data, biopsy sample results (if available), and clinical status Occurrence of new primary NSCLC, as assessed by the investigator Death from any cause","definition_or_measurement_approach":"Disease-free survival (DFS) measured as time from randomization to first of: investigator-determined first recurrence of NSCLC after integrated assessment of radiographic data, biopsy results (if available) and clinical status; occurrence of new primary NSCLC as assessed by investigator; or death from any cause."}

Secondary endpoints

  • {"endpoint_text":"- 1. OS, defined as the time from randomization to death from any cause in the ITT population","definition_or_measurement_approach":"Overall survival (OS) measured as time from randomization to death from any cause in the intent-to-treat (ITT) population."}
  • {"endpoint_text":"- 2. DFS rates at 3 years and 5 years in the PD-L1-subpopulation and in the Stage II-IIIA population and in the ITT population","definition_or_measurement_approach":"Proportion of participants disease-free at 3 and 5 years in specified populations (PD-L1 subpopulation, Stage II-IIIA population, and ITT), using DFS definition above."}
  • {"endpoint_text":"- 3. DFS in the PD-L1-subpopulation within patients with Stage II-IIIA NSCLC","definition_or_measurement_approach":"DFS measured as defined for the PD-L1-defined subpopulation of patients with Stage II–IIIA NSCLC."}

Recruitment

Digital Remote Recruitment
True, recruitment materials and processes include country-specific SMS/messaging templates and SMS opt-in prescreening documents (examples in documents list: "GO29527_Hungary_Hungarian_SMS Messaging Templates", "L1_GO29527_SIS and ICF SMS Opt-In_NL_Dutch_Public", and other country-specific prescreening/SMS templates), indicating use of SMS messaging and digital prescreening in some countries.
Planned Sample Size
819
Recruitment Window Months
123
Consent Approach
Informed consent obtained using Main ICFs and country-specific ICFs; multiple language versions and country-specific ICF documents are listed (examples: English, German, French, Dutch, Hungarian, Italian, Portuguese, Spanish, Polish, Romanian). Consent is by the participant (capacity is required per exclusion criteria). No mention of assent procedures for minors.

Geography

Total Number Of Sites
68
Total Number Of Participants
452

Romania

Earliest CTIS Part Ii Submission Date
05-04-2024
Latest Decision Or Authorization Date
06-11-2024
Processing Time Days
215
Number Of Sites
1
Number Of Participants
4

Sites

Site Name
Centrul De Oncologie SF Nectarie S.R.L.
Department Name
Medical Oncology
Contact Person Name
Michael SCHENKER
Contact Person Email
mike_schenker@yahoo.com

Germany

Earliest CTIS Part Ii Submission Date
05-04-2024
Latest Decision Or Authorization Date
11-05-2026
Processing Time Days
766
Number Of Sites
19
Number Of Participants
100

Sites

Site Name
LungenClinic Grosshansdorf GmbH
Department Name
Onkologie
Contact Person Name
Martin Reck
Contact Person Email
m.reck@lungenclinic.de
Site Name
MVZ Onkologie Velbert GbR
Department Name
MVZ Onkologie Velbert GbR
Contact Person Name
Arnd Nusch
Contact Person Email
nusch@aol.com
Site Name
Martha-Maria Krankenhaus Halle-Doelau gGmbH
Department Name
Klinik für Innere Medizin II
Contact Person Name
Wolfgang Schütte
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
University Comprehensive Cancer Center, II. Medical Clinic
Contact Person Name
Maximilian Christopeit
Contact Person Email
m.christopeit@uke.de
Site Name
Pius-Hospital Oldenburg
Department Name
Klinik für Hämatologie und Onkologie
Contact Person Name
Frank Griesinger
Site Name
SLK-Kliniken Heilbronn GmbH
Department Name
Med. Klinik II Onkologie
Contact Person Name
Jonas Kuon
Contact Person Email
jonas.kuon@slk-kliniken.de
Site Name
Katholisches Klinikum Koblenz Montabaur gGmbH
Department Name
Katholisches Klinikum Koblenz Montabaur gGmbH
Contact Person Name
Selina Hein
Contact Person Email
s.hein@bbtgruppe.de
Site Name
Thoraxklinik Heidelberg gGmbH
Department Name
Thoraxklinik Heidelberg gGmbH
Contact Person Name
Helge Bischoff
Site Name
Klinikum Chemnitz gGmbH
Department Name
Klinik für Innere Medizin IV
Contact Person Name
Stefan Hammerschmidt
Contact Person Email
S.Hammerschmidt@skc.de
Site Name
Asklepios Kliniken Hamburg GmbH
Department Name
Asklepios Kliniken Hamburg GmbH
Contact Person Name
Claas Wesseler
Contact Person Email
c.wesseler@asklepios.com
Site Name
Gemeinschaftspraxis für Hämatologie und Onkologie
Department Name
Gemeinschaftspraxis für Hämatologie und Onkologie
Contact Person Name
Rüdiger Liersch
Contact Person Email
liersch@onkologie-muenster.de
Site Name
Lungenfachklinik Immenhausen
Department Name
Zentrum für Pneumologie
Contact Person Name
Achim Rittmeyer
Site Name
Evangelisches Klinikum Bethel gGmbH
Department Name
Klinik für Innere Medizin, Hämatologie, Onkologie und Palliativmedizin
Contact Person Name
Florian Weißinger
Contact Person Email
Florian.Weissinger@evkb.de
Site Name
Universitaetsklinikum des Saarlandes AöR
Department Name
Saarland University Hospital
Contact Person Name
Jan Alexander Stratmann
Contact Person Email
Jan.Stratmann@uks.eu
Site Name
Lungenklinik Hemer Deutscher Gemeinschafts-Diakonieverband GmbH
Department Name
Lungenklinik Hemer Deutscher Gemeinschafts-Diakonieverband GmbH
Contact Person Name
Markus Lehmann
Contact Person Email
markus.lehmann@lkhemer.de
Site Name
Muenchen Klinik gGmbH
Department Name
Klinik für Pneumologie und Pneumologische Onkologie
Contact Person Name
Konrad Kokowski
Site Name
Staedtisches Klinikum Braunschweig gGmbH
Department Name
Medizinische Klinik III – Hämatologie und Onkologie
Contact Person Name
Miriam Ahlborn
Site Name
Kliniken der Stadt Koeln gGmbH
Department Name
Krankenhaus Merheim Lungenklinik
Contact Person Name
Eva Lotte Buchmeier
Contact Person Email
buchmeiere@kliniken-koeln.de
Site Name
Krankenhaus Nordwest GmbH
Department Name
Institut für Klinisch-Onkologische Forschung
Contact Person Name
Akin Atmaca
Contact Person Email
atmaca.akin@khnw.de

France

Earliest CTIS Part Ii Submission Date
17-05-2024
Latest Decision Or Authorization Date
11-05-2026
Processing Time Days
724
Number Of Sites
10
Number Of Participants
79

Sites

Site Name
Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer
Department Name
Service Pneumologie
Contact Person Name
Clotilde FOURNIER
Contact Person Email
clotilde.fournier@ch-toulon.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Service d’oncologie Médicale
Contact Person Name
Sandrine Hiret
Site Name
Hopital Saint Joseph
Department Name
Service Oncologie
Contact Person Name
Cyril Foa
Contact Person Email
foacyril@club-internet.fr
Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Unité d’Oncologie Thoracique et Cutanée
Contact Person Name
Alain Vergnenegre
Contact Person Email
alain.vergnenegre@unilim.fr
Site Name
Centre Hospitalier Intercommunal De Mont De Marsan Et Du Pays Des Sources
Department Name
Oncologie
Contact Person Name
Paul KIDYBINSKI
Contact Person Email
paul.kidybinski@ch-mdm.fr
Site Name
Centre Hospitalier De Saint-Quentin
Department Name
Service de Pneumologie
Contact Person Name
Charles Dayen
Contact Person Email
c.dayen@ch-stquentin.fr
Site Name
Unite De Recherche Clinique HIA Begin
Department Name
Unité de Recherche Clinique
Contact Person Name
Hugo PICCHI
Contact Person Email
icchi.hugo90@gmail.com
Site Name
HIA Sainte Anne
Department Name
Service de Pneumologie
Contact Person Name
Olivier Bylicki
Contact Person Email
bylicki.olivier@yahoo.fr
Site Name
Centre Leon Berard
Department Name
Département d’Oncologie Médicale
Contact Person Name
Maurice Perol
Site Name
Institut Regional Du Cancer De Montpellier
Department Name
Service de Pneumologie
Contact Person Name
Xavier Quantin

Netherlands

Earliest CTIS Part Ii Submission Date
05-04-2024
Latest Decision Or Authorization Date
04-05-2026
Processing Time Days
365
Number Of Sites
3
Number Of Participants
7

Sites

Site Name
Jeroen Bosch Ziekenhuis
Contact Person Name
Sietske Smulders
Contact Person Email
s.smulders@jbz.nl
Site Name
St. Antonius Ziekenhuis
Contact Person Name
Franz Schramel
Site Name
Stichting Martini Ziekenhuis
Contact Person Name
Wouter Jacobs
Contact Person Email
w.jacobs@mzh.nl

Hungary

Earliest CTIS Part Ii Submission Date
05-04-2024
Latest Decision Or Authorization Date
11-05-2026
Processing Time Days
372
Number Of Sites
4
Number Of Participants
63

Sites

Site Name
Reformatus Pulmonologiai Centrum
Department Name
III. Osztály
Contact Person Name
Tibor Borbély
Contact Person Email
drborbelytibor@t-online.hu
Site Name
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet
Department Name
Onkológiai Központ
Contact Person Name
Hajnalka Németh
Contact Person Email
nemethhajnalka@hotmail.com
Site Name
University Of Pecs
Department Name
I. sz. Belgyógyászati Klinika - Tüdőgyógyászat
Contact Person Name
Veronika Sárosi
Contact Person Email
sarosi.veronika@gmail.com
Site Name
Clinic Of Pulmonology Semmelweis University
Department Name
Pulmonológiai Klinika
Contact Person Name
György Losonczy

Italy

Earliest CTIS Part Ii Submission Date
05-04-2024
Latest Decision Or Authorization Date
05-05-2026
Processing Time Days
766
Number Of Sites
10
Number Of Participants
57

Sites

Site Name
Azienda Ospedaliera Santa Croce E Carle
Department Name
Struttura Complessa di Oncologia
Contact Person Name
Ida Colantonio
Contact Person Email
colantonio.i@ospedale.cuneo.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Unità Operativa di Oncologia Medica - Dipartimento di Oncologia
Contact Person Name
Francesca Ogliari
Contact Person Email
ogliari.francesca@hsr.it
Site Name
Azienda Sanitaria Locale 2 Lanciano Vasto Chieti
Department Name
Oncologia Medica
Contact Person Name
Michele De Tursi
Contact Person Email
detursi@unich.it
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
Struttura Complessa Oncologia Medica 1
Contact Person Name
Enrica Milanesi
Contact Person Email
enricami74@libero.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
U.O. Oncologia Medica
Contact Person Name
Andrea Alberti
Contact Person Email
a.alberti015@unibs.it
Site Name
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
Department Name
U.O.Oncologia Medica
Contact Person Name
Giuseppe Tonini
Contact Person Email
g.tonini@policlinicocampus.it
Site Name
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Department Name
S.C. Oncologia Medica
Contact Person Name
Gloria Borra
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
U.O. Pneumologia 2
Contact Person Name
Antonio Chella
Contact Person Email
anto.kell@tiscali.it
Site Name
Centro Di Riferimento Oncologico Di Aviano
Department Name
SOC Oncologia Medica e dei Tumori lmmunocorrelati
Contact Person Name
Brigida Stanzione
Contact Person Email
brigida.stanzione@cro.it
Site Name
Hospital Santa Maria Della Misericordia
Department Name
Oncologia Medica
Contact Person Name
Giulio Metro

Spain

Earliest CTIS Part Ii Submission Date
29-04-2024
Latest Decision Or Authorization Date
06-05-2026
Processing Time Days
768
Number Of Sites
15
Number Of Participants
116

Sites

Site Name
University Hospital Son Espases
Department Name
Oncology
Contact Person Name
Monica Guillot
Contact Person Email
monicam.guillot@ssib.es
Site Name
Hospital Clinico Universitario Lozano Blesa
Department Name
Oncology
Contact Person Name
Maria Dolores Isla Casado
Contact Person Email
lola.isla@gmail.com
Site Name
Fundacion Centro Oncologico Regional De Galicia Jose Antonio Quiroga Y Pineyro
Department Name
Oncology
Contact Person Name
Margarita Amenedo Gancedo
Contact Person Email
margarita.amenedo@cog.es
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Oncology
Contact Person Name
Marta Lopez Brea
Contact Person Email
marta.lopezbrea@gmail.com
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Oncology
Contact Person Name
Oscar Jose Juan Vidal
Contact Person Email
juan_osc@gva.es
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Oncology
Contact Person Name
Margarita Majem Tarruela
Contact Person Email
mmajem@santpau.cat
Site Name
Hospital Clinico San Carlos
Department Name
Oncology
Contact Person Name
Javier Puente Vazquez
Contact Person Email
javierpuente.hcsc@gmail.com
Site Name
Hospital General Universitario Reina Sofia
Department Name
Oncology
Contact Person Name
Isidoro Carlos Barneto Aranda
Contact Person Email
isidoroc.barneto@gmail.com
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Oncology
Contact Person Name
Pilar Garrido López
Contact Person Email
pilargarridol@gmail.com
Site Name
Hospital Universitario Lucus Augusti
Department Name
Oncology
Contact Person Name
Sergio Vazquez Estevez
Site Name
Hospital Universitario De Canarias
Department Name
Oncology
Contact Person Name
Juana Oramas
Contact Person Email
juanaoramas@gmail.com
Site Name
Hospital Del Mar
Department Name
Oncology
Contact Person Name
Alvaro Taus Garcia
Contact Person Email
96720@parcdesalutmar.cat
Site Name
Hospital General Universitario De Castellon
Department Name
Oncology
Contact Person Name
Alfredo Sanchez Hernandez
Contact Person Email
asanchezh@seom.org
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Oncology
Contact Person Name
Amelia Insa Molla
Contact Person Email
ameliainsamolla@gmail.com
Site Name
Institut Catala D'oncologia
Department Name
Oncology
Contact Person Name
Teresa Moran
Contact Person Email
mmoran@iconcologia.net

Poland

Earliest CTIS Part Ii Submission Date
02-05-2024
Latest Decision Or Authorization Date
08-05-2026
Processing Time Days
371
Number Of Sites
2
Number Of Participants
12

Sites

Site Name
Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy
Department Name
Oddział III - Chorób Płuc z Pododdziałem Onkologicznym
Contact Person Name
Aleksandra Szczesna
Contact Person Email
ola_szczesna@outlook.com
Site Name
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow
Department Name
Oddział Onkologii Klinicznej z Pododdziałem Dziennej Chemioterapii
Contact Person Name
Katarzyna Stencel
Contact Person Email
kstencel@wcpit.org

Portugal

Earliest CTIS Part Ii Submission Date
29-04-2024
Latest Decision Or Authorization Date
05-05-2026
Processing Time Days
372
Number Of Sites
4
Number Of Participants
14

Sites

Site Name
Unidade Local de Saude de Sao Joao E.P.E.
Department Name
Serviço de Pneumologia
Contact Person Name
Gabriela Fernandes
Contact Person Email
gabrielafer75@gmail.com
Site Name
Unidade Local De Saude De Coimbra E.P.E.
Department Name
Serviço de Pneumologia
Contact Person Name
Fernando Barata
Contact Person Email
fjssbarata@gmail.com
Site Name
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Department Name
Serviço de Oncologia Médica
Contact Person Name
Júlio Oliveira
Site Name
Unidade Local De Saude De Santa Maria E.P.E.
Department Name
Serviço de Pneumologia
Contact Person Name
Paula Alves
Contact Person Email
alvespaula57@gmail.com

Sponsor

Primary sponsor

Full Name
F. Hoffmann-La Roche AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Contract research organisations

Name
PPD Development LP
Responsibilities
Global CRO
Name
Icon Development Solutions LLC
Responsibilities
sponsorDuties code: 4
Name
Bioclinica Inc.
Responsibilities
sponsorDuties code: 4
Name
Q Squared Solutions Holdings LLC
Responsibilities
sponsorDuties code: 4
Name
Q Squared Solutions (Beijing) Co. Ltd.
Responsibilities
sponsorDuties code: 4
Name
Signant Health Global LLC
Responsibilities
sponsorDuties code: 3

Third parties

  • {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Icon Development Solutions LLC","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Roche Sequencing Solutions Inc.","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Foundation Medicine Inc.","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"sponsorDuties code: 3","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Natera Inc.","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Q Squared Solutions Holdings LLC","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Precision For Medicine Inc.","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"China","full_name":"Q Squared Solutions (Beijing) Co. Ltd.","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"Global CRO","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Tecentriq
Active Substance
ATEZOLIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
IV INFUSION
Route
IV INFUSION
Authorisation Status
prodAuthStatus: 1 (euMpNumber PRD5674603)
Maximum Dose
1200 mg
Investigational Product Name
Tecentriq 1,200 mg concentrate for solution for infusion
Active Substance
ATEZOLIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
IV INFUSION
Route
IV INFUSION
Authorisation Status
Authorised (marketingAuthNumber EU/1/17/1220/001)
Maximum Dose
1200 mg

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