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).

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

Carcinoma, Non-Small-Cell Lung

Carcinoma, Non-small-Cell Lung

Carcinoma, Non-Small Cell Lung

Non-Small Cell Lung Cancer

Non-Small-Cell Lung Carcinoma

Lung Cancer

Lung; Node

Cancer of the Lung

Cancer of Lung

Neoplasms, Lung

Lung Neoplasms

Advanced Solid Tumors

Cancer

Advanced Solid Malignancies

Advanced Solid Tumor

Solid Tumor, Adult

Neoplasms

Adenocarcinoma

Advanced Stage Solid Tumors

Prospective, Multi Country, Observational Study of Clinical Outcomes in EGFR-mutated, Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Treated With Approved Amivantamab-containing Regimens Under Standard Clinical Practice

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.

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.

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.

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.

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.

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.

Participants with Dose Modifications and Discontinuations of Amivantamab, Lazertinib and Chemotherapy will be reported.

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.

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.

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.

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.

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.

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.

The purpose of this study is to describe the clinical and health-related outcomes of
amivantamab-containing regimens for the treatment of advanced 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).

Prospective, Multi-Country, Observational Study of Clinical Outcomes in EGFR-mutated, Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Treated With Approved Amivantamab-containing Regimens Under Standard Clinical Practice

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.

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.

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.

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.

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.

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.

Participants with Dose Modifications and Discontinuations of Amivantamab, Lazertinib and
Chemotherapy will be reported.

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.

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.

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.

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.

Participants with confirmed diagnosis of advanced NSCLC with activating EGFR exon 20
insertion mutations (first-line therapy) who received at least 1 dose of amivantamab in
combination with chemotherapy (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.

Participants with confirmed diagnosis of advanced NSCLC with EGFR exon 19 deletions or
exon 21 L858R substitution mutations, after failure of prior therapy including a
third-generation EGFR TKI (second-line therapy), who received at least 1 dose of
amivantamab in combination with chemotherapy (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.

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.

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

Trials at a glance

Trials at a glance

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

Outcome measures

Primary outcome measures

Secondary outcome measures