Carcinoma, Non-Small-Cell Lung
Conditions
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-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).
Interventions
None listed
Sponsors
Janssen Research & Development, LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Real-World Time to Treatment Discontinuation (rwTTD) | Up to approximately 60 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events (AEs) by Severity | Up to approximately 60 Months | 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. |
| Number of Participants with Dose Modifications and Discontinuations of Amivantamab, Lazertinib and Chemotherapy | Up to approximately 60 Months | Participants with Dose Modifications and Discontinuations of Amivantamab, Lazertinib and Chemotherapy will be reported. |
| Number of Participants Using Concomitant Medications | Up to approximately 60 Months | 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. |
| Real-World Progression-Free Survival (rwPFS) | Up to approximately 60 Months | 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. |
| Real-World Time to Next Treatment (rwTTNT) | Up to approximately 60 Months | 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. |
| Real-World Overall Survival (rwOS) | Up to approximately 60 Months | 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. |
| Health-Related Quality of Life (HRQoL) Assessed by SKINDEX Scale Score | Up to approximately 60 Months | 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. |
| 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 | Up to approximately 60 Months | 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. |
| Real-World Time to Subsequent Treatment Discontinuation (rwTTD2) | Up to approximately 60 Months | 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. |
| Quality of Life Impact on Questions Regarding Reactive and Prophylactic Management of AEs Related to the Amivantamab-Containing Regimen | Up to approximately 60 Months | 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. |
Countries
Austria, Belgium, Czechia, Germany, Israel, Italy, Spain, United Kingdom
Contacts
CONTACTStudy Contact
STUDY_DIRECTORJanssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Outcome results
None listed