A Study of DM005 in Patients With Advanced Solid Tumors
NCT06515990
Bronchial Neoplasms, Carcinoma
Detroit, Michigan, United States
View Trial DetailsNCT Number: NCT07230691
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).
Interested in participating?
Request Info18 year and older
All sexes
Observational
University Hospital Graz, Graz, Austria
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to approximately 60 Months
Participants with Dose Modifications and Discontinuations of Amivantamab, Lazertinib and Chemotherapy will be reported.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Janssen Research & Development, LLC
Industry
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
Acronym: LEPIDOPTERA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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