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| ID | Type | Description | Link |
|---|---|---|---|
| 61186372NSC4014 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to describe the clinical and health-related outcomes of amivantamab-containing regimens for the treatment of common epidermal growth factor receptor (EGFR) mutated non-small cell lung cancer (NSCLC; most common type of lung cancer) in a real-world setting. Metastatic NSCLC is when this disease spreads to other parts of body. NSCLC may occur due to mutations (changes) in many genes including epidermal growth factor receptor (EGFR).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort B: Amivantamab with carboplatin and pemetrexed | Participants with confirmed diagnosis of advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations after failure of prior therapy including an EGFR TKI, who received at least 1 dose of amivantamab in combination with carboplatin and pemetrexed, as per standard clinical practice will be enrolled. No drug will be provided as part of this study. Only data available within routine clinical practice will be collected in this study. | ||
| Cohort C: Amivantamab and lazertinib | Participants with confirmed diagnosis of advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations (first-line therapy) who received at least 1 dose of amivantamab in combination with lazertinib as per standard clinical practice will be enrolled. No drug will be provided as part of this study. Only data available within routine clinical practice will be collected in this study. |
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| Measure | Description | Time Frame |
|---|---|---|
| Real-World Time to Treatment Discontinuation (rwTTD) | rwTTD is defined as the time from the date of initiation of the amivantamab-containing regimen to discontinuation of the full amivantamab containing regimen for any reason, including disease progression, treatment toxicity or death. | Up to approximately 60 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Real-World Progression-Free Survival (rwPFS) | rwPFS is defined as the time from the date of initiation of the amivantamab-containing regimen to the date of investigator-determined disease progression (radiological or clinical) or death due to any cause, whichever occurs first. | Up to approximately 60 Months |
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Inclusion Criteria:
Exclusion criteria:
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The study population will include participants with advanced NSCLC.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Contact | Contact | 844-434-4210 | Participate-In-This-Study1@its.jnj.com |
| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Graz | Recruiting | Graz | 8036 | Austria | ||
| Klinikum Klagenfurt am Worthersee |
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| Real-World Time to Next Treatment (rwTTNT) |
rwTTNT is defined as the time from initiation of the amivantamab-containing regimen to start of a subsequent systemic treatment following discontinuation of the full amivantamab-containing regimen or death, whichever occurs first. |
| Up to approximately 60 Months |
| Real-World Overall Survival (rwOS) | rwOS is defined as the time from the date of initiation of the amivantamab-containing regimen to the date of death from any cause or reason. | Up to approximately 60 Months |
| Real-World Time to Subsequent Treatment Discontinuation (rwTTD2) | rwTTD2 is defined as the time from initiation of the amivantamab-containing regimen to the discontinuation of the first subsequent therapy for any reason, including disease progression, treatment toxicity or death. | Up to approximately 60 Months |
| Number of Participants with Adverse Events (AEs) by Severity | An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. | Up to approximately 60 Months |
| Number of Participants with Dose Modifications and Discontinuations of Amivantamab, Lazertinib and Chemotherapy | Participants with Dose Modifications and Discontinuations of Amivantamab, Lazertinib and Chemotherapy will be reported. | Up to approximately 60 Months |
| Number of Participants Using Concomitant Medications | Participants using concomitant medications including those to manage specific AEs related to the amivantamab-containing regimen, namely infusion related reactions (IRRs), venous thromboembolism (VTEs), and dermatologic AEs including paronychia, will be reported. | Up to approximately 60 Months |
| Health-Related Quality of Life (HRQoL) Assessed by SKINDEX Scale Score | The SKINDEX-16 measures how a participant's skin condition impacts their health-related quality of life. There are 16 questions on a 7-point scale, ranging from 0 (never bothered) to 6 (always bothered). The questionnaire is divided into 3 domains: symptoms (items 1 to 4), emotions (items 5 to 11), and functionality (items 12 to 16). An overall score is the average of the 3 domain scores. All domain scores will be linearly transformed to be in the range from 0 to 100. A score of 0 indicates that the skin condition has no impact on QoL, while a score of 100 indicates the worst possible impact. | Up to approximately 60 Months |
| Quality of Life Assessed by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30) Items-30 Scale Score | The EORTC QLQ-C30 is a self-administered, 30-item questionnaire measuring the HRQoL of participants with cancer. EORTC QLQ-C30 includes 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea and vomiting), a global health status / quality of life scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Responses to items 1-28 are rated on a 4-point Likert response scale ranging from 1 "Not at all" to 4 "Very much." Two global health status items are rated on a 7-point numeric rating scale from 1 "Very Poor" to 7 "Excellent." Higher scores indicate greater functioning, better global health status, and more severe symptoms. | Up to approximately 60 Months |
| Quality of Life Impact on Questions Regarding Reactive and Prophylactic Management of AEs Related to the Amivantamab-Containing Regimen | Three questions regarding reactive and prophylactic management of AEs related to the amivantamab-containing regimen will be reported. These questions cover the type of prophylactic/reactive concomitant medication recommended by the treating physician, frequency of use, and the degree of impact on daily life due to use of the respective medication. | Up to approximately 60 Months |
| Recruiting |
| Klagenfurt |
| 9020 |
| Austria |
| UZ Brussel | Recruiting | Brussels | 1090 | Belgium |
| UZ Antwerpen | Recruiting | Edegem | 2650 | Belgium |
| Jessa Ziekenhuis | Recruiting | Hasselt | 3500 | Belgium |
| Az Groeninge | Recruiting | Kortrijk | 8500 | Belgium |
| Chu Helora Hospital La Louviere Site Jolimont | Recruiting | La Louvière | 7100 | Belgium |
| CHU de Liege | Recruiting | Liège | 4000 | Belgium |
| Vitaz | Recruiting | Sint-Niklaas | 9100 | Belgium |
| Fakultni nemocnice Brno | Recruiting | Brno | 625 00 | Czechia |
| Fakultni nemocnice Hradec Kralove | Recruiting | Hradec Králové | 500 05 | Czechia |
| Fakultni nemocnice Olomouc | Recruiting | Olomouc | 77900 | Czechia |
| Fakultni Thomayerova nemocnice | Recruiting | Prague | 140 59 | Czechia |
| MVZ am Klinikum Aschaffenburg Onkologie | Recruiting | Aschaffenburg | 63739 | Germany |
| Evangelisches Klinikum Bethel | Recruiting | Bielefeld | 33611 | Germany |
| Augusta Kliniken Bochum Hattingen | Recruiting | Bochum | 44791 | Germany |
| Klinikum Chemnitz gGmbH | Recruiting | Chemnitz | 09113 | Germany |
| Haematologie u Onkologie Koeln MV Zentrum | Recruiting | Cologne | 50677 | Germany |
| Kliniken der Stadt Köln gGmbH, Krankenhaus Köln-Mehrheim | Recruiting | Cologne | 51109 | Germany |
| Kliniken Essen-Mitte; Evangelische Huyssens-Stiftung | Recruiting | Essen | 45136 | Germany |
| Universitaetsklinikum Essen | Recruiting | Essen | 45147 | Germany |
| Facharztzentrum Eppendorf | Recruiting | Hamburg | 20249 | Germany |
| Onkologie am Raschplatz | Recruiting | Hanover | 30161 | Germany |
| Klinikum Region Hannover Klinikum Siloah | Recruiting | Hanover | 30449 | Germany |
| Lungenklinik Hemer | Recruiting | Hemer | 58675 | Germany |
| Klinikum Konstanz | Recruiting | Konstanz | 78464 | Germany |
| MVZ fur Hamatologie und Onkologie Rhein Kreis GmbH | Recruiting | Neuss | 41462 | Germany |
| Knappschaft Kliniken MVZ Nord GmbH | Recruiting | Recklinghausen | 45659 | Germany |
| MVZ Onkologie Groschek Keller | Recruiting | Stolberg | 52222 | Germany |
| Bundeswehrkrankenhaus Ulm | Recruiting | Ulm | 89081 | Germany |
| Rabin Medical Center | Recruiting | Petah Tikva | 4941492 | Israel |
| Sheba Medical Center | Recruiting | Ramat Gan | 5262000 | Israel |
| Assuta MC | Recruiting | Tel Aviv | 6971028 | Israel |
| Ospedale San Giuseppe Moscati di Avellino | Recruiting | Avellino | 83100 | Italy |
| Oncologia Medica - Irccs - Istituto Tumori Giovanni Paolo II | Recruiting | Bari | 70124 | Italy |
| ASST Spedali Civili Brescia | Recruiting | Brescia | 25123 | Italy |
| Istituto di Candiolo, IRCCS | Recruiting | Candiolo | 10060 | Italy |
| PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania | Recruiting | Catania | 95123 | Italy |
| Azienda Ospedaliera Pugliese Ciaccio Catanzaro | Recruiting | Catanzaro | 88100 | Italy |
| Ospedale Policlinico San Martino IRCCS | Recruiting | Genova | 16132 | Italy |
| Azienda Ospedaliera ''Vito Fazzi'' | Recruiting | Lecce | 73100 | Italy |
| San Raffaele Hospital | Recruiting | Milan | 20132 | Italy |
| Istituto Dei Tumori Di Milano | Recruiting | Milan | 20133 | Italy |
| European Institute of Oncology | Recruiting | Milan | 20141 | Italy |
| ASST Grande Ospedale Metropolitano Niguarda | Recruiting | Milan | 20162 | Italy |
| San Gerardo Hospital | Recruiting | Monza | 20900 | Italy |
| Fondazione G Pascale Istituto Nazionale Tumori IRCCS | Recruiting | Naples | 80131 | Italy |
| Azienda Ospedaliero Universitaria Maggiore della Carita di Novara | Recruiting | Novara | 28100 | Italy |
| ASL Gallura - Ospedale Giovanni Paolo II | Recruiting | Olbia | 07026 | Italy |
| Aou San Luigi Gonzaga | Recruiting | Orbassano | 10043 | Italy |
| Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone | Recruiting | Palermo | 90127 | Italy |
| A.O.R Villa Sofia Cervello | Recruiting | Palermo | 90146 | Italy |
| Azienda Ospedaliero-Universitaria Di Parma | Recruiting | Parma | 43126 | Italy |
| Fondazione Policlinico Universitario A Gemelli IRCCS | Recruiting | Roma | 00168 | Italy |
| Campus Bio Medico di Roma | Recruiting | Roma | 128 | Italy |
| Istituto Nazionale Tumori Regina Elena | Recruiting | Rome | 00144 | Italy |
| Azienda Ospedaliero Universitaria di Sassari | Recruiting | Sassari | 07100 | Italy |
| Ospedali Riuniti Di Ancona | Recruiting | Torrette-Ancona | 60126 | Italy |
| Azienda Sanitaria Territoriale Pesaro Urbino | Recruiting | Urbino | 61121 | Italy |
| Hosp Reina Sofia | Recruiting | Córdoba | 14004 | Spain |
| Hosp. de Jerez de La Frontera | Recruiting | Jerez de la Frontera | 11407 | Spain |
| Hosp. Univ. Lucus Augusti | Recruiting | Lugo | 27003 | Spain |
| Complexo Hosp. Univ. de Ourense | Recruiting | Ourense | 32005 | Spain |
| Hosp. Univ. Son Espases | Recruiting | Palma de Mallorca | 07120 | Spain |
| Hosp. Clinico Univ. de Santiago | Recruiting | Santiago de Compostela | 15706 | Spain |
| Hospital Universitario Virgen Rocio | Recruiting | Seville | 41013 | Spain |
| Hosp. Clinico Univ. de Valladolid | Recruiting | Valladolid | 47003 | Spain |
| Royal United Hospital | Recruiting | Bath | BA1 3NG | United Kingdom |
| Velindre Hospital | Recruiting | Cardiff | CF14 2TL | United Kingdom |
| Eastbourne District General Hospital | Recruiting | Eastbourne | BN21 2UD | United Kingdom |
| Royal Surrey County Hospital NHS Trust | Recruiting | Guildford | GU2 7XX | United Kingdom |
| New Cross Hospital | Recruiting | Heath Town | WV10 0QP | United Kingdom |
| Royal Marsden Hospital | Recruiting | London | SW3 6JJ | United Kingdom |
| The Christie NHS Foundation Trust Christie Hospital | Recruiting | Manchester | M20 4BX | United Kingdom |
| Royal Marsden Hospital (Sutton) | Recruiting | Sutton | SM2 5PT | United Kingdom |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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