A Study of Clinical Outcomes in Participants With EGFR Mutated Advanced Non-Small Cell Lung Cancer (NSCLC) in a Real-World Setting

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJanssen Research & Development, LLC

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial population

The study population will include participants with advanced NSCLC.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

380 Participants
are grouped into 2 trial groups
Group A: Cohort B: Amivantamab with carboplatin and pemetrexed
Group B: Cohort C: Amivantamab and lazertinib

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to approximately 60 Months

Secondary outcomes

1

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.

Time frame
Up to approximately 60 Months
2

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.

Time frame
Up to approximately 60 Months
3

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.

Time frame
Up to approximately 60 Months
4

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.

Time frame
Up to approximately 60 Months

Other outcomes

Sponsors and contacts

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