Status:
RECRUITING
A Study of Clinical Outcomes in Participants With EGFR Mutated Advanced Non-Small Cell Lung Cancer (NSCLC) in a Real-World Setting
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Brief Summary
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-sma...
Eligibility Criteria
Inclusion
- Participant has a confirmed diagnosis of common epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) (EGFR exon 19 deletions or exon 21 L858R substitution) and is eligible for an amivantamab-containing regimen per the judgment of the treating physician and in alignment with the approved amivantamab indications and recommended prophylactic and reactive medication as described in the local specific summary of product characteristics (SmPC) for amivantamab
- Participants or their legally acceptable representative, where applicable, must sign a participation agreement/Informed consent form (ICF) allowing source data verification in accordance with local requirements
- Participant is being planned to be initiated with an amivantamab-containing regimen for the first time within 4 weeks following the visit for start of data collection
- Decision to administer an amivantamab-containing regimen has been made prior to participant's enrollment in the study and is separate from the physician's decision to include the participant in the current study
Exclusion
- At the time of the initiation of the amivantamab-containing regimen, the participant is receiving an active systemic anticancer treatment for advanced NSCLC that is not included in the locally approved combination regimen with amivantamab (regardless of whether it is part of an interventional study). One cycle of platinum-based chemotherapy (for example, carboplatin-pemetrexed) is permitted prior to the first dose of amivantamab in a 1L while awaiting biopsy results
- Participant has received prior treatment with amivantamab in a clinical trial or for compassionate use
- Participants who are not receiving amivantamab but are being treated with a biosimilar or a non-original biologic agent
- Participants with conditions listed in the contraindications of the SmPC for amivantamab or other agents essential for the applicable amivantamab-containing treatment regimen (lazertinib/ platinum/ pemetrexed)
Key Trial Info
Start Date :
December 3 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 17 2030
Estimated Enrollment :
380 Patients enrolled
Trial Details
Trial ID
NCT07230691
Start Date
December 3 2025
End Date
December 17 2030
Last Update
March 13 2026
Active Locations (45)
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1
Klinikum Klagenfurt am Worthersee
Klagenfurt, Austria, 9020
2
Fakultni nemocnice Brno
Brno, Czechia, 625 00
3
Fakultni nemocnice Hradec Kralove
Hradec Králové, Czechia, 500 05
4
Fakultni nemocnice Olomouc
Olomouc, Czechia, 77900