Tokyo, June 29 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061941) titled 'Real-World Characteristics, Treatment Patterns, and Outcomes of Patients with cEGFRm NSCLC Treated with amivantamab + lazertinib, osimertinib + chemotherapy, and osimertinib monotherapy in the 1L Setting (REDAdmiral): A Non-Interventional, Multi-Country, Multi-Center, Multi-Wave, Retrospective Chart Review Study' on June 29.

Study Type: Observational

Primary Sponsor: Institute - Janssen Pharmaceutical K.K.

Condition: Condition - Non-small cell lung cancer Classification by malignancy - Malignancy Genomic information - YES

Objective: Narrative objectives1 - collecting and analyzing data for adults with advanced/metastatic cEGFRm NSCLC treated with Ami+Lazer, Osi+Chemo, or Osi-Mono (optional cohort) in the real-world 1L setting. Basic objectives2 - Safety,Efficacy

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1.Confirmed diagnosis of advanced/metastatic cEGFRm (Ex19del or L858R) NSCLC. 2.Initiation of first-line treatment in real-world clinical practice with Ami+Lazer, Osi+Chemo, or Osi-Mono (optional cohort), with at least one dose of each agent in the regimen administered. a. The first-line treatment must be prescribed by the participating site or physician (if a retrospective site-/panel-based chart review approach is used). b. The index date is defined as the date of first administration of any agent in the regimen. c. Chemotherapy as part of the Osi+Chemo regimen includes pemetrexed and a platinum agent (carboplatin or cisplatin). 3.Aged 18 years or older at the index date. 4.If applicable and in accordance with local requirements, the patient (and/or, where applicable, a legally acceptable representative) has signed the participation agreement or informed consent form (ICF) and provided permission for direct access to source documents (the ICF may be waived if approved by the Independent Ethics Committee [IEC] or Institutional Review Board [IRB]). Key exclusion criteria - 1.Enrolled in a clinical trial for any part of 1L treatment in advanced/metastatic NSCLC However, in Japan, patients enrolled in a clinical trial and receiving treatment with either Ami + Lazer or Osi + Chemotherapy under the national health insurance system shall be eligible for inclusion in this study. 2.Receipt of 1L treatment (e.g., Ami+Lazer, Osi+Chemo, Osi-Mono) in combination with another systemic treatment medication (e.g., bevacizumab, ramucirumab, erlotinib, gefitinib) in the 1L setting Target Size - 750

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 11 Month 07 Day Date of IRB - 2026 Year 05 Month 21 Day Anticipated trial start date - 2026 Year 06 Month 29 Day Last follow-up date - 2033 Year 11 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070871

Disclaimer: Curated by HT Syndication.