Clinical Trial: LONG-TERM FOLLOW-UP OF OSIMERTINIB IN COMBINATION WITH PLATINUM AND PEMETREXED IN PATIENTS WITH PREVIOUSLY UNTREATED EGFR-MUTATED ADVANCED NON-SQUAMOUS NON-SMALL CELL LUNG CANCER (THE OPAL STUDY): (NEJ032D) (Japan)

Tokyo, March 4 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060812) titled 'LONG-TERM FOLLOW-UP OF OSIMERTINIB IN COMBINATION WITH PLATINUM AND PEMETREXED IN PATIENTS WITH PREVIOUSLY UNTREATED EGFR-MUTATED ADVANCED NON-SQUAMOUS NON-SMALL CELL LUNG CANCER (THE OPAL STUDY): (NEJ032D)' on March 4.

Study Type: Observational

Primary Sponsor: Institute - North East Japan Study Group

Condition: Condition - previously untreated EGFR-mutated advanced non-squamous NSCLC Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - We aim to conduct a long-term follow-up data analysis of the phase II OPAL trial, which evaluated osimertinib plus platinum-based chemotherapy (cisplatin or carboplatin) and pemetrexed in patients with previously untreated EGFR-mutated advanced non-squamous NSCLC, to clarify the long-term efficacy of this regimen and its effectiveness in previously unreported subgroup populations. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. All 67 patients (34 in the cisplatin group and 33 in the carboplatin group) enrolled in the phase II trial of osimertinib in combination with platinum-pemetrexed in patients with EGFR-mutated previously untreated advanced non-small cell Lung cancer (the OPAL study) conducted between March 1, 2019 and May 31, 2024. Trial: Phase II trial of osimertinib in combination with platinum-pemetrexed in patients with EGFR-mutated previously untreated advanced non-small cell Lung cancer (the OPAL study)

2. Individuals who did not express refusal to participate in this study, either themselves or through a representative who could act on their behalf and in their best interests. Key exclusion criteria - Patients who withdrew their consent. Target Size - 67

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 01 Month 14 Day Anticipated trial start date - 2026 Year 03 Month 14 Day Last follow-up date - 2026 Year 10 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069570

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