Tokyo, Oct. 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063248) titled 'Real-world data on the effectiveness and safety of MARIPOSA/MARIPOSA-2 regimens after first-line osimertinib-based therapy in EGFR-mutated NSCLC: A multicenter prospective observational study (NEJ073)' on Oct. 13.

Study Type: Observational

Primary Sponsor: Institute - NHO Osaka Toneyama Medical Center

Condition: Condition - Advanced non-small cell lung cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To evaluate the effectiveness and safety of the amivantamab-based regimens (MARIPOSA/MARIPOSA-2) following first-line osimertinib-based therapy (FLAURA or FLAURA2 regimens) in patients with EGFR mutation-positive non-small cell lung cancer, and to assess clinical factors associated with treatment outcomes and indirectly compare the effectiveness with established standard treatments. Basic objectives2 - Safety,Efficacy

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1) Pathologically confirmation of non small cell lung cancer 2) The history of EGFR-TKI therapies 3) Not eligible for surgery or definitive radiotherapy 4) Disease progression has been confirmed following first-line osimertinib-based therapy 5) Administration of amivantamab-based therapy (MARIPOSA/MARIPOSA-2) is planned 6) Presence of evaluable lesions (with or without measurable lesions according to RECIST Version 1.1) 7) Aged 20 or more 8) Written informed consent Key exclusion criteria - 1) Patients who received osimertinib as adjuvant chemotherapy or as consolidation therapy following curative radiation therapy (ADAURA, LAURA). 2) Patients with active interstitial lung disease. Target Size - 100

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 04 Month 28 Day Date of IRB - 2026 Year 09 Month 24 Day Anticipated trial start date - 2026 Year 10 Month 13 Day Last follow-up date - 2030 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072313

Disclaimer: Curated by HT Syndication.