Tokyo, July 29 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062375) titled 'A prospective observational study of amivantamab plus lazertinib in patients with EGFR-mutated non-small cell lung cancer previously treated with osimertinib (NJLCG2501)' on July 28.

Study Type: Observational

Primary Sponsor: Institute - Tohoku University

Condition: Condition - EGFR-mutated advanced or recurrent non-small cell lung cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To prospectively evaluate the efficacy and safety of amivantamab plus lazertinib in patients with EGFR-mutated advanced or recurrent non-small cell lung cancer previously treated with osimertinib. Basic objectives2 - Safety,Efficacy

Eligibility: Age-lower limit - 20 years-old =1,500/mm3; hemoglobin >=9.0 g/dL; platelet count >=100,000/mm3; total bilirubin =94% or PaO2 >=70 Torr on room air. - Expected survival of 3 months or longer from enrollment. - Written informed consent obtained from the patient after sufficient explanation of the study. Key exclusion criteria - - Symptomatic brain metastases or symptomatic meningeal carcinomatosis. - Radiotherapy with a field including the chest (including palliative irradiation) within the preceding 2 weeks, or scheduled in the near future. Palliative radiotherapy whose field does not include the lung (e.g., for bone metastases) is allowed. - Active interstitial lung disease. - Clinically significant coagulation disorder. - Contraindication to amivantamab or lazertinib. - Participation in another clinical study for which co-enrollment in this study is not permitted. - History of severe drug hypersensitivity. - Any other condition that the physician judges to make the patient inappropriate for participation in this study. Target Size - 33

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 07 Month 03 Day Date of IRB - 2026 Year 07 Month 23 Day Anticipated trial start date - 2026 Year 07 Month 23 Day Last follow-up date - 2029 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071329

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