JOURNAL ONKOLOGIE – STUDIE
A Study Investigating the Outcomes and Safety of Atezolizumab Under Real-World Conditions in Patients Treated in Routine Clinical Practice
Rekrutierend
NCT-Nummer:
NCT03782207
Studienbeginn:
Februar 2019
Letztes Update:
08.04.2021
Wirkstoff:
Atezolizumab
Indikation (Clinical Trials):
Lung Neoplasms, Small Cell Lung Carcinoma, Carcinoma, Carcinoma, Hepatocellular
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
-
Sponsor:
Hoffmann-La Roche
Collaborator:
-
Studienleiter
Study Director
Hoffmann-La Roche
Kontakt
Kontakt:
Phone: 888-662-6728 (U.S. and Canada)
E-Mail: global-roche-genentech-trials@gene.com» Kontaktdaten anzeigen
Studienlocations
(3 von 280)
C1426ANZ Buenos Aires
ArgentinaRekrutierend» Google-Maps
C1426AGE Caba
ArgentinaRekrutierend» Google-Maps
C1405CUB Ciudad Autónoma de Buenos Aires
ArgentinaRekrutierend» Google-Maps
X5000JHQ Cordoba
ArgentinaRekrutierend» Google-Maps
S2000ORE Rosario
ArgentinaRekrutierend» Google-Maps
4400 Salta
ArgentinaZurückgezogen» Google-Maps
6300 Santa Rosa
ArgentinaRekrutierend» Google-Maps
9020 Klagenfurt
AustriaRekrutierend» Google-Maps
3500 Krems
AustriaRekrutierend» Google-Maps
4840 Vöcklabruck
AustriaRekrutierend» Google-Maps
4600 Wels
AustriaRekrutierend» Google-Maps
1160 Wien
AustriaZurückgezogen» Google-Maps
2930 Brasschaat
BelgiumRekrutierend» Google-Maps
9000 Gent
BelgiumZurückgezogen» Google-Maps
2800 Mechelen
BelgiumAktiv, nicht rekrutierend» Google-Maps
5530 Mont-godinne
BelgiumRekrutierend» Google-Maps
8400 Oostende
BelgiumRekrutierend» Google-Maps
8800 Roeselare
BelgiumRekrutierend» Google-Maps
3800 Sint-Truiden
BelgiumRekrutierend» Google-Maps
38408-150 Uberlandia
BrazilZurückgezogen» Google-Maps
87015-200 Maringa
BrazilNoch nicht rekrutierend» Google-Maps
Rio de Janeiro
BrazilNoch nicht rekrutierend» Google-Maps
Rio de Janeiro
BrazilZurückgezogen» Google-Maps
01323-900 Sao Paulo
BrazilRekrutierend» Google-Maps
4500 Panagyurishte
BulgariaRekrutierend» Google-Maps
5800 Pleven
BulgariaRekrutierend» Google-Maps
4001 Plovdiv
BulgariaRekrutierend» Google-Maps
4004 Plovdiv
BulgariaRekrutierend» Google-Maps
4004 Plovdiv
BulgariaRekrutierend» Google-Maps
Plovdiv
BulgariaZurückgezogen» Google-Maps
7000 Ruse
BulgariaRekrutierend» Google-Maps
1431 Sofia
BulgariaZurückgezogen» Google-Maps
1632 Sofia
BulgariaRekrutierend» Google-Maps
Sofia
BulgariaRekrutierend» Google-Maps
9010 Varna
BulgariaRekrutierend» Google-Maps
510515 Guangdong Province Guangzhou City
ChinaNoch nicht rekrutierend» Google-Maps
510120 Guangzhou
ChinaNoch nicht rekrutierend» Google-Maps
250117 Jinan
ChinaNoch nicht rekrutierend» Google-Maps
210008 Nanjing City
ChinaNoch nicht rekrutierend» Google-Maps
211100 Nanjing City
ChinaNoch nicht rekrutierend» Google-Maps
210036 Nanjing
ChinaNoch nicht rekrutierend» Google-Maps
530021 Nanning
ChinaNoch nicht rekrutierend» Google-Maps
300052 Tianjin
ChinaNoch nicht rekrutierend» Google-Maps
300060 Tianjin
ChinaNoch nicht rekrutierend» Google-Maps
221000 Xuzhou
ChinaNoch nicht rekrutierend» Google-Maps
450003 Zhengzhou
ChinaNoch nicht rekrutierend» Google-Maps
Bogota
ColombiaRekrutierend» Google-Maps
760045 Cali
ColombiaRekrutierend» Google-Maps
Cali
ColombiaRekrutierend» Google-Maps
50010 Medellin
ColombiaRekrutierend» Google-Maps
31000 Osijek
CroatiaAktiv, nicht rekrutierend» Google-Maps
21000 Split
CroatiaAktiv, nicht rekrutierend» Google-Maps
10000 Zagreb
CroatiaAktiv, nicht rekrutierend» Google-Maps
10000 Zagreb
CroatiaAktiv, nicht rekrutierend» Google-Maps
10000 Zagreb
CroatiaAktiv, nicht rekrutierend» Google-Maps
Alexandria
EgyptRekrutierend» Google-Maps
11391 Cairo
EgyptRekrutierend» Google-Maps
Cairo
EgyptRekrutierend» Google-Maps
Cairo
EgyptRekrutierend» Google-Maps
Cairo
EgyptRekrutierend» Google-Maps
47000 Agen
FranceAktiv, nicht rekrutierend» Google-Maps
13616 Aix En Provence
FranceAktiv, nicht rekrutierend» Google-Maps
80090 Amiens
FranceAktiv, nicht rekrutierend» Google-Maps
49933 Angers
FranceAktiv, nicht rekrutierend» Google-Maps
92166 Antony
FranceAktiv, nicht rekrutierend» Google-Maps
84902 Avignon
FranceAktiv, nicht rekrutierend» Google-Maps
60000 Beauvais
FranceAktiv, nicht rekrutierend» Google-Maps
25030 Besancon
FranceAktiv, nicht rekrutierend» Google-Maps
34525 Beziers
FranceAktiv, nicht rekrutierend» Google-Maps
33030 Bordeaux
FranceAktiv, nicht rekrutierend» Google-Maps
33077 Bordeaux
FranceAktiv, nicht rekrutierend» Google-Maps
14000 Caen
FranceAktiv, nicht rekrutierend» Google-Maps
73011 Chambery
FranceAktiv, nicht rekrutierend» Google-Maps
37170 Chambray Les Tours
FranceAktiv, nicht rekrutierend» Google-Maps
63003 Clermont-ferrand
FranceZurückgezogen» Google-Maps
63003 Clermont-ferrand
FranceAktiv, nicht rekrutierend» Google-Maps
60321 Compiegne
FranceAktiv, nicht rekrutierend» Google-Maps
60109 Creil
FranceAktiv, nicht rekrutierend» Google-Maps
21079 Dijon
FranceAktiv, nicht rekrutierend» Google-Maps
95602 Eaubonne
FranceAktiv, nicht rekrutierend» Google-Maps
05007 GAP
FranceAktiv, nicht rekrutierend» Google-Maps
69400 Gleize
FranceAktiv, nicht rekrutierend» Google-Maps
17019 La Rochelle
FranceAktiv, nicht rekrutierend» Google-Maps
45100 La Source
FranceAktiv, nicht rekrutierend» Google-Maps
28630 Le Coudray
FranceAktiv, nicht rekrutierend» Google-Maps
28630 Le Coudray
FranceAktiv, nicht rekrutierend» Google-Maps
72000 Le Mans
FranceAktiv, nicht rekrutierend» Google-Maps
59042 Lille
FranceAktiv, nicht rekrutierend» Google-Maps
87042 Limoges
FranceAktiv, nicht rekrutierend» Google-Maps
56100 Lorient
FranceAktiv, nicht rekrutierend» Google-Maps
69008 Lyon
FranceAktiv, nicht rekrutierend» Google-Maps
13003 Marseille
FranceAktiv, nicht rekrutierend» Google-Maps
34070 Montpellier
FranceAktiv, nicht rekrutierend» Google-Maps
34298 Montpellier
FranceAktiv, nicht rekrutierend» Google-Maps
68070 Mulhouse
FranceAktiv, nicht rekrutierend» Google-Maps
30029 Nimes
FranceAktiv, nicht rekrutierend» Google-Maps
30900 Nimes
FranceAktiv, nicht rekrutierend» Google-Maps
75005 Paris
FranceAktiv, nicht rekrutierend» Google-Maps
75014 Paris
FranceAktiv, nicht rekrutierend» Google-Maps
75908 Paris
FranceAktiv, nicht rekrutierend» Google-Maps
64046 PAU
FranceAktiv, nicht rekrutierend» Google-Maps
66000 Perpignan
FranceAktiv, nicht rekrutierend» Google-Maps
86021 Poitiers
FranceZurückgezogen» Google-Maps
74374 Pringy
FranceAktiv, nicht rekrutierend» Google-Maps
51092 Reims
FranceAktiv, nicht rekrutierend» Google-Maps
44606 Saint Nazaire
FranceAktiv, nicht rekrutierend» Google-Maps
42770 Saint Priest En Jarez
FranceAktiv, nicht rekrutierend» Google-Maps
Sarreguemines
FranceAktiv, nicht rekrutierend» Google-Maps
02321 St Quentin
FranceAktiv, nicht rekrutierend» Google-Maps
83056 Toulon
FranceAktiv, nicht rekrutierend» Google-Maps
31059 Toulouse
FranceAktiv, nicht rekrutierend» Google-Maps
31076 Toulouse
FranceZurückgezogen» Google-Maps
26000 Valence
FranceAktiv, nicht rekrutierend» Google-Maps
59326 Valenciennes Cedex
FranceAktiv, nicht rekrutierend» Google-Maps
56017 Vannes
FranceAktiv, nicht rekrutierend» Google-Maps
57070 Vantoux
FranceAktiv, nicht rekrutierend» Google-Maps
1083 Budapest
HungaryRekrutierend» Google-Maps
1121 Budapest
HungaryAktiv, nicht rekrutierend» Google-Maps
4032 Debrecen
HungaryRekrutierend» Google-Maps
7623 Pecs
HungaryAktiv, nicht rekrutierend» Google-Maps
2045 Törökbálint
HungaryRekrutierend» Google-Maps
8410100 Beer Sheva
IsraelNoch nicht rekrutierend» Google-Maps
3109601 Haifa
IsraelNoch nicht rekrutierend» Google-Maps
5262100 Ramat Gan
IsraelNoch nicht rekrutierend» Google-Maps
67100 L'Aquila
ItalyRekrutierend» Google-Maps
85028 Rionero In Vulture (PZ)
ItalyRekrutierend» Google-Maps
89133 Reggio Calabria
ItalyRekrutierend» Google-Maps
80131 Napoli
ItalyRekrutierend» Google-Maps
80131 Napoli
ItalyRekrutierend» Google-Maps
47014 Meldola
ItalyRekrutierend» Google-Maps
41100 Modena
ItalyRekrutierend» Google-Maps
00152 Roma
ItalyRekrutierend» Google-Maps
03039 Sora
ItalyRekrutierend» Google-Maps
16132 Genova
ItalyRekrutierend» Google-Maps
37045 Legnago
ItalyRekrutierend» Google-Maps
20122 Milano
ItalyRekrutierend» Google-Maps
20142 Milano
ItalyRekrutierend» Google-Maps
21100 Varese
ItalyRekrutierend» Google-Maps
15100 Alessandria
ItalyRekrutierend» Google-Maps
73044 Lecce
ItalyRekrutierend» Google-Maps
09121 Cagliari
ItalyRekrutierend» Google-Maps
95122 Catania
ItalyRekrutierend» Google-Maps
90146 Palermo
ItalyRekrutierend» Google-Maps
50134 Firenze
ItalyRekrutierend» Google-Maps
55043 Lido Di Camaiore
ItalyRekrutierend» Google-Maps
39100 Bolzano
ItalyZurückgezogen» Google-Maps
36100 Vicenza
ItalyRekrutierend» Google-Maps
1107 2090 Beirut
LebanonRekrutierend» Google-Maps
2624 0000 Bsalim, Mount Lebanon-Metn
LebanonAktiv, nicht rekrutierend» Google-Maps
50009 Kaunas
LithuaniaRekrutierend» Google-Maps
LT-08660 Vilnius
LithuaniaRekrutierend» Google-Maps
66220 San Pedro Garza García
MexicoRekrutierend» Google-Maps
14050 Mexico City
MexicoRekrutierend» Google-Maps
1091 AC Amsterdam
NetherlandsAktiv, nicht rekrutierend» Google-Maps
9401 RK Assen
NetherlandsZurückgezogen» Google-Maps
7416 SE Deventer
NetherlandsZurückgezogen» Google-Maps
5623 EJ Eindhoven
NetherlandsAktiv, nicht rekrutierend» Google-Maps
8934 AD Leeuwarden
NetherlandsAktiv, nicht rekrutierend» Google-Maps
3079 DZ Rotterdam
NetherlandsZurückgezogen» Google-Maps
3582 KE Utrecht
NetherlandsZurückgezogen» Google-Maps
1502 DV Zaandam
NetherlandsAktiv, nicht rekrutierend» Google-Maps
1014 Manila
PhilippinesRekrutierend» Google-Maps
1300 Pasay
PhilippinesRekrutierend» Google-Maps
1104 Quezon City
PhilippinesRekrutierend» Google-Maps
43-360 Bystra
PolandZurückgezogen» Google-Maps
80-219 Gdansk
PolandZurückgezogen» Google-Maps
44-101 Gliwice
PolandAktiv, nicht rekrutierend» Google-Maps
86-300 Grudziądz
PolandAktiv, nicht rekrutierend» Google-Maps
40-514 Katowice
PolandZurückgezogen» Google-Maps
20-954 Lublin
PolandAktiv, nicht rekrutierend» Google-Maps
10-357 Olsztyn
PolandAktiv, nicht rekrutierend» Google-Maps
05-400 Otwock
PolandAktiv, nicht rekrutierend» Google-Maps
60-569 Poznan
PolandAktiv, nicht rekrutierend» Google-Maps
01-138 Warszawa
PolandAktiv, nicht rekrutierend» Google-Maps
04-141 Warszawa
PolandZurückgezogen» Google-Maps
53-439 Wroclaw
PolandZurückgezogen» Google-Maps
91-520 Łódź
PolandAktiv, nicht rekrutierend» Google-Maps
93-513 Łódź
PolandAktiv, nicht rekrutierend» Google-Maps
3041-801 Coimbra
PortugalAktiv, nicht rekrutierend» Google-Maps
1400-038 Lisboa
PortugalAktiv, nicht rekrutierend» Google-Maps
1796-001 Lisboa
PortugalAktiv, nicht rekrutierend» Google-Maps
4454-509 Matosinhos
PortugalAktiv, nicht rekrutierend» Google-Maps
4099-001 Porto
PortugalAktiv, nicht rekrutierend» Google-Maps
4100-180 Porto
PortugalAktiv, nicht rekrutierend» Google-Maps
4434-502 Vila Nova De Gaia
PortugalAktiv, nicht rekrutierend» Google-Maps
510073 Alba Iulia
RomaniaNoch nicht rekrutierend» Google-Maps
021389 Bucharest
RomaniaNoch nicht rekrutierend» Google-Maps
Bucharest
RomaniaNoch nicht rekrutierend» Google-Maps
022328 Bucuresti
RomaniaNoch nicht rekrutierend» Google-Maps
Bucuresti
RomaniaZurückgezogen» Google-Maps
900591 Constanta
RomaniaNoch nicht rekrutierend» Google-Maps
700483 Iasi
RomaniaNoch nicht rekrutierend» Google-Maps
100337 Ploiesti
RomaniaNoch nicht rekrutierend» Google-Maps
300239 Timisoara
RomaniaNoch nicht rekrutierend» Google-Maps
300166 Timişoara
RomaniaNoch nicht rekrutierend» Google-Maps
Saint Petersburg
Russian FederationRekrutierend» Google-Maps
248007 Kaluga
Russian FederationRekrutierend» Google-Maps
420029 Kazan
Russian FederationRekrutierend» Google-Maps
660133 Krasnoyarsk
Russian FederationRekrutierend» Google-Maps
197758 Saint-Petersburg
Russian FederationRekrutierend» Google-Maps
450054 UFA
Russian FederationRekrutierend» Google-Maps
11000 Belgrade
SerbiaAktiv, nicht rekrutierend» Google-Maps
1000 Ljubljana
SloveniaRekrutierend» Google-Maps
2000 Maribor
SloveniaRekrutierend» Google-Maps
04009 Almería
SpainZurückgezogen» Google-Maps
04009 Almería
SpainRekrutierend» Google-Maps
08304 Mataro
SpainAktiv, nicht rekrutierend» Google-Maps
8208 Sabadell
SpainRekrutierend» Google-Maps
07014 Palma De Mallorca
SpainAktiv, nicht rekrutierend» Google-Maps
15706 Santiago de Compostela
SpainRekrutierend» Google-Maps
35020 Las Palmas de Gran Canaria
SpainNoch nicht rekrutierend» Google-Maps
28222 Majadahonda
SpainRekrutierend» Google-Maps
28223 Pozuelo de Alarcon
SpainRekrutierend» Google-Maps
28702 San Sebastian de Los Reyes
SpainRekrutierend» Google-Maps
31008 Pamplona
SpainZurückgezogen» Google-Maps
31008 Pamplona
SpainRekrutierend» Google-Maps
31008 Pamplona
SpainRekrutierend» Google-Maps
38320 La Laguna
SpainRekrutierend» Google-Maps
38320 La Laguna
SpainAktiv, nicht rekrutierend» Google-Maps
38010 Santa Cruz de Tenerife
SpainRekrutierend» Google-Maps
06080 Badajoz
SpainRekrutierend» Google-Maps
08041 Barcelona
SpainRekrutierend» Google-Maps
08041 Barcelona
SpainZurückgezogen» Google-Maps
09006 Burgos
SpainRekrutierend» Google-Maps
10003 Caceres
SpainRekrutierend» Google-Maps
13005 Ciudad Real
SpainZurückgezogen» Google-Maps
18016 Granada
SpainRekrutierend» Google-Maps
19002 Guadalajara
SpainZurückgezogen» Google-Maps
23007 Jaen
SpainRekrutierend» Google-Maps
24071 Leon
SpainRekrutierend» Google-Maps
27003 Lugo
SpainRekrutierend» Google-Maps
28040 Madrid
SpainAbgeschlossen» Google-Maps
28046 Madrid
SpainRekrutierend» Google-Maps
28050 Madrid
SpainRekrutierend» Google-Maps
32005 Orense
SpainRekrutierend» Google-Maps
40002 Segovia
SpainRekrutierend» Google-Maps
41014 Sevilla
SpainAktiv, nicht rekrutierend» Google-Maps
45004 Toledo
SpainZurückgezogen» Google-Maps
47005 Valladolid
SpainRekrutierend» Google-Maps
50009 Zaragoza
SpainRekrutierend» Google-Maps
50009 Zaragoza
SpainAktiv, nicht rekrutierend» Google-Maps
Abu Dhabi
United Arab EmiratesNoch nicht rekrutierend» Google-Maps
15258 Al Ain
United Arab EmiratesRekrutierend» Google-Maps
EN5 3DJ Barnet
United KingdomRekrutierend» Google-Maps
BA1 3NG Bath
United KingdomRekrutierend» Google-Maps
CH63 4JY Bebington
United KingdomRekrutierend» Google-Maps
B9 5SS Birmingham
United KingdomRekrutierend» Google-Maps
BB10 2PQ Burnley
United KingdomRekrutierend» Google-Maps
CB2 0QQ Cambridge
United KingdomNoch nicht rekrutierend» Google-Maps
CF14 2TL Cardiff
United KingdomRekrutierend» Google-Maps
DN33 2BA Grimsby
United KingdomRekrutierend» Google-Maps
GU2 7XX Guildford
United KingdomRekrutierend» Google-Maps
HA1 3UJ Harrow
United KingdomRekrutierend» Google-Maps
HD3 3EA Huddersfield
United KingdomRekrutierend» Google-Maps
HU3 2JZ Hull
United KingdomRekrutierend» Google-Maps
BD20 6TD Keighley
United KingdomRekrutierend» Google-Maps
KT2 7QB Kingston upon Thames
United KingdomRekrutierend» Google-Maps
EC1A 7BE London
United KingdomRekrutierend» Google-Maps
NW3 2QG London
United KingdomRekrutierend» Google-Maps
SE1 9RT London
United KingdomRekrutierend» Google-Maps
SE18 4QH London
United KingdomRekrutierend» Google-Maps
SW17 0QT London
United KingdomRekrutierend» Google-Maps
SW3 6JJ London
United KingdomRekrutierend» Google-Maps
W12 OHS London
United KingdomRekrutierend» Google-Maps
W6 8RF London
United KingdomRekrutierend» Google-Maps
ME16 9QQ Maidstone
United KingdomRekrutierend» Google-Maps
M20 4BX Manchester
United KingdomRekrutierend» Google-Maps
NE7 7DN Newcastle upon Tyne
United KingdomRekrutierend» Google-Maps
NG5 1PB Nottingham
United KingdomRekrutierend» Google-Maps
OX3 7LJ Oxford
United KingdomRekrutierend» Google-Maps
PR2 9HT Preston
United KingdomRekrutierend» Google-Maps
S10 2SJ Sheffield
United KingdomRekrutierend» Google-Maps
ST4 6QG Stoke-on-Trent
United KingdomRekrutierend» Google-Maps
SM2 5PT Sutton
United KingdomRekrutierend» Google-Maps
TQ27AA Torquay
United KingdomRekrutierend» Google-Maps
TR1 3LQ Truro
United KingdomAktiv, nicht rekrutierend» Google-Maps
WF1 4DG Wakefield
United KingdomRekrutierend» Google-Maps
SN3 6BB Wiltshire
United KingdomRekrutierend» Google-Maps
WV10 0QP Wolverhampton
United KingdomRekrutierend» Google-Maps
YO31 8HE York
United KingdomRekrutierend» Google-Maps
Studien-Informationen
Detailed Description:The study will be split into separate cohorts based on the approved indications for
atezolizumab treatment, excluding cisplatin ineligible participants receiving atezolizumab as
first line of therapy (LOT1) for locally advanced/metastatic urothelial cancer (locally
advanced/metastatic UC). The study may be amended for inclusion of new cohorts as these are
approved in the participating countries. Participants will be included into each cohort based
on their indication for receiving atezolizumab.
Ein-/Ausschlusskriterien
Inclusion Criteria:- Patient must have one of the following confirmed diagnoses for which atezolizumab is
locally approved in the SmPC: (1) As monotherapy for the treatment of adult patients
with locally advanced/metastatic UC after prior platinum-containing chemotherapy
(Cohort 1 LOT2+mUC) or (2) As monotherapy for the treatment of adult patients with
locally advanced/metastatic NSCLC after prior chemotherapy. Patients with EGFR
activating mutations or ALK-positive tumour mutations should also have received
targeted therapy before receiving atezolizumab (Cohort 2 LOT2+NSCLC) or (3) In
combination with bevacizumab, paclitaxel and carboplatin for the first line treatment
of adult patients with metastatic non-squamous NSCLC. Patients with EGFR activating
mutations or ALK- positive tumour mutations should also have received targeted therapy
(Cohort 3 LOT1 NSCLC) or (4) In combination with carboplatin and etoposide, is
indicated for the first-line treatment of adult patients with extensive-stage small
cell lung cancer (ES-SCLC) (Cohort 4 LOT1 ES-SCLC) or (5) As a monotherapy, for the
treatment of metastatic NSCLC with high PD-L1 expression, previously untreated (Cohort
5 LOT1 NSCLC) or (6) In combination with bevacizumab for unresectable locally advanced
or metastatic hepatocellular carcinoma previously untreated with systemic therapy
(Cohort 6 LOT1 HCC) .
- Patient is administered atezolizumab therapy for the first time.
- Decision to administer atezolizumab must be made and documented prior to inclusion
into the study and must follow local clinical practice.
Exclusion Criteria:
- Patients not receiving treatment for a disease with atezolizumab according to standard
of care and in line with the current summary of product characteristics (SPC) or local
labelling. Cisplatin ineligible patients receiving atezolizumab LOT1 for the treatment
of locally advanced/metastatic UC patients will be excluded
- Concomitant anti-cancer therapy at the time of starting atezolizumab on the index date
not part of locally approved combination therapy with atezolizumab.
- Treatment with atezolizumab as part of a clinical trial or for compassionate use as
part of a pre-approval or compassionate use program.
- Patients not receiving atezolizumab, but a biosimilar or non-original biologic.
Studien-Rationale
Primary outcome:1. Overall Survival (OS) (Time Frame - Index date up to approximately 6 years):
Time from index date until date of death from any cause. Index date is the date of administration of the first ever dose of atezolizumab for each patient.
2. OS at 2 Years (Time Frame - After index date up to 2 years):
Percentage of participants alive 2 years after initiation of atezolizumab treatment.
Secondary outcome:
1. Time to Loss of Clinical Benefit (TTLCB) (Time Frame - Index date up to approximately 6 years):
Time from the index date to loss of clinical benefit as assessed by the treating physician.
2. Progression Free Survival (PFS) (Time Frame - Index date up to approximately 6 years):
Time from index date to death or disease progression (PD).
3. Objective Response Rate (ORR) (Time Frame - After index date up to approximately 6 years):
Percentage of participants who have a best overall response (BOR) of Complete Response (CR) or Partial Response (PR). BOR for each participant is the best response achieved after the index date prior to initiation of any subsequent treatment.
4. Time to Response (Time Frame - Index date up to approximately 6 years):
Time from index date to first objective tumor response, CR or PR.
5. Duration of Response (DoR) (Time Frame - Index date up to approximately 6 years):
Time from first documentation of CR or PR (whichever occurs first) after index until death or PD.
6. Disease Control Rate (DCR) (Time Frame - From 12 weeks after index date up to approximately 6 years):
Percentage of participants who have achieved CR, PR and stable disease at least 12 weeks after the index date.
7. Duration of DCR (Time Frame - After index date up to approximately 6 years):
Time from first documentation of CR, PR or stable disease (whichever occurs first) after index until death or PD.
8. EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Score (Time Frame - Index date or after ICF signature, & approx. at 6, 12, and 24 weeks of treatment; then at approx. 3 months, 6 months, 12 months, & every 12 months thereafter until end of study (study planned duration up to approximately 6 years)):
EQ-5D-5L during and after atezolizumab treatment will be used to assess HRQoL. Scale is from 1-5 (no problems, slight problems, moderate problems, severe problems and extreme problems).
9. WPAI-GH Score (Time Frame - Index date or after ICF signature, & approx. at 6, 12, & 24 weeks of treatment; then at approx. 3 months, 6 months, 12 months, & every 12 months thereafter until end of study (study planned duration up to approximately 6 years)):
Work Productivity and Activity Impairment Questionnaire General Health V2.0 (WPAI-GH) during and after atezolizumab treatment will be used to assess the ability to work. The WPAI-GH is a standardized questionnaire used to measure the impact of health on work performance. From the WPAI-GH, absenteeism (the percentage of work time missed), presenteeism (the percentage of time when working that productivity is impaired), overall work impairment (a combination of absenteeism and presenteeism), and total activity impairment (the percentage of impairment in daily activities) can be measured.
10. Number of Paricipants with Disease Stage TNM and IUCC (Time Frame - At index date (Index date is the date of administration of the first ever dose of atezolizumab for each patient.))
11. Number of Participants at Each Level of Karnofsky or ECOG Performance Status (Time Frame - At index date (Index date is the date of administration of the first ever dose of atezolizumab for each patient.)
12. Total Number of Infusions of Atezolizuamb (Time Frame - Treatment period until discontinuation (up to approximately 6 years))
13. Duration of Treatment With Atezolizumab (Time Frame - Index date until date of treatment discontinuation (up to approximately 6 years))
14. Time to initiation of subsequent cancer-related therapies (Time Frame - Up to approximately 6 years)
15. Percentage of Participants with Adverse Events (Time Frame - Up to approximately 6 years)
Studien-Arme
- Cohort 1 (UC LOT2+later lines[LOT2+] & platinum eligible LOT1)
Participants diagnosed with locally advanced or metastatic Urothelial Cancer previously treated with platinum-containing chemotherapy. Enrollment is closed. - Cohort 2 (NSCLC LOT2 plus later lines [LOT2+])
Participants diagnosed with Locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) after prior chemotherapy. Participants with epidermal growth factor receptor (EGFR) activating mutations or anaplastic lymphoma kinase (ALK)-positive tumor mutations should also have received targeted therapy. Enrollment closed. - Cohort 3 (NSCLC LOT1 plus EGFR+/ALK+ LOT2+)
EMA: Participants diagnosed with locally advanced/metastatic non-squamous NSCLC not previously treated. Participants with EGFR-activating mutations or ALK-positive tumor mutations should have received at least one line of targeted therapy. FDA: for the treatment of adult participants with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. Participants with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for NSCLC harboring these aberrations prior to receiving TECENTRIQ. - Cohort 4 (ES-SCLC LOT1)
Participants diagnosed with extensive stage (ES) small cell lung cancer (SCLC) not previously treated. - Cohort 5 (NSCLC LOT1)
Participants diagnosed with metastatic Non-Small Cell Lung cancer with high PD-L1 expression, previously untreated. - Cohort 6 (HCC LOT1)
Participants diagnosed with unresectable locally advanced or metastatic hepatocellular carcinoma previously untreated with systemic therapy.
Geprüfte Regime
- Atezolizumab (Tecentriq):
Atezolizumab will be administered at the discretion of the treating physician per local guidelines and independently of participation in this study.
Quelle: ClinicalTrials.gov
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