Actively Recruiting
Observational Study of Clinical Outcomes in EGFR-Mutated Advanced Non-Small Cell Lung Cancer Patients Treated with Amivantamab-Containing Regimens Under Routine Clinical Practice
Led by Janssen Research & Development, LLC · Updated on 2026-06-05
380
Participants Needed
70
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the outcomes of treatments containing amivantamab for people with advanced non-small cell lung cancer (NSCLC) that have specific mutations in the epidermal growth factor receptor (EGFR) gene. This research focuses on patients with common EGFR mutations, including exon 19 deletions or exon 21 L858R substitutions, to understand how these regimens perform in real-world medical practice. The study aims to capture clinical and health-related results for this serious lung cancer type, particularly when it has spread to other parts of the body. The study observes two groups of participants receiving amivantamab-based treatments as part of their standard care. One group includes patients treated with amivantamab combined with carboplatin and pemetrexed after previous therapy has failed. The other group involves participants receiving amivantamab with lazertinib as their first-line therapy. No study drugs are provided; instead, researchers collect data from routine clinical visits, tracking how patients are treated according to usual medical practice. Participants are monitored for up to about 60 months to gather information on how long they continue treatment, progression-free survival, overall survival, and time to next treatment. Researchers also record adverse events, dose changes, use of other medications, and quality of life using specific questionnaires. This long-term observation helps to understand treatment impact and safety in everyday clinical settings without additional interventions or procedures beyond standard care.
CONDITIONS
Brief Title
A Study of Clinical Outcomes in Participants With EGFR Mutated Advanced Non-Small Cell Lung Cancer (NSCLC) in a Real-World Setting
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant has a confirmed diagnosis of common EGFR-mutated non-small cell lung cancer (exon 19 deletions or exon 21 L858R substitution)
- Eligible for an amivantamab-containing regimen according to treating physician and local approved indications
- Participant or legal representative must sign informed consent allowing data verification
- Planned initiation of amivantamab-containing regimen for the first time within 4 weeks of data collection start
- Decision to use amivantamab-containing regimen made before enrollment and separate from study inclusion decision
You will not qualify if you...
- Receiving active systemic anticancer treatment for advanced NSCLC not included in approved amivantamab combination regimen at treatment start (one cycle of platinum-based chemotherapy allowed before amivantamab in first-line therapy)
- Prior amivantamab treatment in clinical trial or compassionate use
- Receiving biosimilar or non-original biologic agents instead of amivantamab
- Any conditions listed as contraindications in the summary of product characteristics for amivantamab or agents required in the treatment regimen (lazertinib, platinum, pemetrexed)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 60 months
Participants who undergo routine care with amivantamab-containing regimens are observed to collect data on clinical outcomes and quality of life.
Visits as per routine clinical practice
Trial Site Locations
Total: 70 locations
1
University Hospital Graz
Graz, Austria, 8036
Actively Recruiting
2
Klinikum Klagenfurt am Worthersee
Klagenfurt, Austria, 9020
Actively Recruiting
3
UZ Brussel
Brussels, Belgium, 1090
Actively Recruiting
4
UZ Antwerpen
Edegem, Belgium, 2650
Actively Recruiting
5
Jessa Ziekenhuis
Hasselt, Belgium, 3500
Actively Recruiting
6
Az Groeninge
Kortrijk, Belgium, 8500
Actively Recruiting
7
Chu Helora Hospital La Louviere Site Jolimont
La Louvière, Belgium, 7100
Actively Recruiting
8
CHU de Liege
Liège, Belgium, 4000
Actively Recruiting
9
Vitaz
Sint-Niklaas, Belgium, 9100
Actively Recruiting
10
Fakultni nemocnice Brno
Brno, Czechia, 625 00
Actively Recruiting
11
Fakultni nemocnice Hradec Kralove
Hradec Králové, Czechia, 500 05
Actively Recruiting
12
Fakultni nemocnice Olomouc
Olomouc, Czechia, 77900
Actively Recruiting
13
Fakultni Thomayerova nemocnice
Prague, Czechia, 140 59
Actively Recruiting
14
MVZ am Klinikum Aschaffenburg Onkologie
Aschaffenburg, Germany, 63739
Actively Recruiting
15
Evangelisches Klinikum Bethel
Bielefeld, Germany, 33611
Actively Recruiting
16
Augusta Kliniken Bochum Hattingen
Bochum, Germany, 44791
Actively Recruiting
17
Klinikum Chemnitz gGmbH
Chemnitz, Germany, 09113
Actively Recruiting
18
Haematologie u Onkologie Koeln MV Zentrum
Cologne, Germany, 50677
Actively Recruiting
19
Kliniken der Stadt Köln gGmbH, Krankenhaus Köln-Mehrheim
Cologne, Germany, 51109
Actively Recruiting
20
Kliniken Essen-Mitte; Evangelische Huyssens-Stiftung
Essen, Germany, 45136
Actively Recruiting
21
Facharztzentrum Eppendorf
Hamburg, Germany, 20249
Actively Recruiting
22
Onkologie am Raschplatz
Hanover, Germany, 30161
Actively Recruiting
23
Klinikum Region Hannover Klinikum Siloah
Hanover, Germany, 30449
Actively Recruiting
24
Lungenklinik Hemer
Hemer, Germany, 58675
Actively Recruiting
25
Klinikum Konstanz
Konstanz, Germany, 78464
Actively Recruiting
26
MVZ fur Hamatologie und Onkologie Rhein Kreis GmbH
Neuss, Germany, 41462
Actively Recruiting
27
Knappschaft Kliniken MVZ Nord GmbH
Recklinghausen, Germany, 45659
Actively Recruiting
28
MVZ Onkologie Groschek Keller
Stolberg, Germany, 52222
Actively Recruiting
29
Bundeswehrkrankenhaus Ulm
Ulm, Germany, 89081
Actively Recruiting
30
Rabin Medical Center
Petah Tikva, Israel, 4941492
Actively Recruiting
31
Sheba Medical Center
Ramat Gan, Israel, 5262000
Actively Recruiting
32
Assuta MC
Tel Aviv, Israel, 6971028
Actively Recruiting
33
Ospedale San Giuseppe Moscati di Avellino
Avellino, Italy, 83100
Actively Recruiting
34
Oncologia Medica - Irccs - Istituto Tumori Giovanni Paolo II
Bari, Italy, 70124
Actively Recruiting
35
ASST Spedali Civili Brescia
Brescia, Italy, 25123
Actively Recruiting
36
Istituto di Candiolo, IRCCS
Candiolo, Italy, 10060
Actively Recruiting
37
PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania
Catania, Italy, 95123
Actively Recruiting
38
Azienda Ospedaliera Pugliese Ciaccio Catanzaro
Catanzaro, Italy, 88100
Actively Recruiting
39
Ospedale Policlinico San Martino IRCCS
Genova, Italy, 16132
Actively Recruiting
40
Azienda Ospedaliera ''Vito Fazzi''
Lecce, Italy, 73100
Actively Recruiting
41
San Raffaele Hospital
Milan, Italy, 20132
Actively Recruiting
42
Istituto Dei Tumori Di Milano
Milan, Italy, 20133
Actively Recruiting
43
European Institute of Oncology
Milan, Italy, 20141
Actively Recruiting
44
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy, 20162
Actively Recruiting
45
Fondazione G Pascale Istituto Nazionale Tumori IRCCS
Naples, Italy, 80131
Actively Recruiting
46
Azienda Ospedaliero Universitaria Maggiore della Carita di Novara
Novara, Italy, 28100
Actively Recruiting
47
ASL Gallura - Ospedale Giovanni Paolo II
Olbia, Italy, 07026
Actively Recruiting
48
Aou San Luigi Gonzaga
Orbassano, Italy, 10043
Actively Recruiting
49
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
Palermo, Italy, 90127
Actively Recruiting
50
A.O.R Villa Sofia Cervello
Palermo, Italy, 90146
Actively Recruiting
51
Azienda Ospedaliero-Universitaria Di Parma
Parma, Italy, 43126
Actively Recruiting
52
Fondazione Policlinico Universitario A Gemelli IRCCS
Roma, Italy, 00168
Actively Recruiting
53
Campus Bio Medico di Roma
Roma, Italy, 128
Actively Recruiting
54
Azienda Ospedaliero Universitaria di Sassari
Sassari, Italy, 07100
Actively Recruiting
55
Ospedali Riuniti Di Ancona
Torrette-Ancona, Italy, 60126
Actively Recruiting
56
Hosp Reina Sofia
Córdoba, Spain, 14004
Actively Recruiting
57
Hosp. de Jerez de La Frontera
Jerez de la Frontera, Spain, 11407
Actively Recruiting
58
Hosp. Univ. Lucus Augusti
Lugo, Spain, 27003
Actively Recruiting
59
Complexo Hosp. Univ. de Ourense
Ourense, Spain, 32005
Actively Recruiting
60
Hosp. Univ. Son Espases
Palma de Mallorca, Spain, 07120
Actively Recruiting
61
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, Spain, 15706
Actively Recruiting
62
Hospital Universitario Virgen Rocio
Seville, Spain, 41013
Actively Recruiting
63
Hosp. Clinico Univ. de Valladolid
Valladolid, Spain, 47003
Actively Recruiting
64
Royal United Hospital
Bath, United Kingdom, BA1 3NG
Actively Recruiting
65
Eastbourne District General Hospital
Eastbourne, United Kingdom, BN21 2UD
Actively Recruiting
66
Royal Surrey County Hospital NHS Trust
Guildford, United Kingdom, GU2 7XX
Actively Recruiting
67
New Cross Hospital
Heath Town, United Kingdom, WV10 0QP
Actively Recruiting
68
Royal Marsden Hospital
London, United Kingdom, SW3 6JJ
Actively Recruiting
69
The Christie NHS Foundation Trust Christie Hospital
Manchester, United Kingdom, M20 4BX
Actively Recruiting
70
Royal Marsden Hospital (Sutton)
Sutton, United Kingdom, SM2 5PT
Actively Recruiting
Research Team
S
Study Contact
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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