Tokyo, Aug. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062582) titled 'Study of the Effectiveness and Safety of Drug Therapy Including Immune Checkpoint Inhibitors for Unresectable Advanced Invasive Mucinous Adenocarcinoma of the Lung' on Aug. 14.

Study Type: Observational

Primary Sponsor: Institute - Specified Nonprofit Corporation North East Japan Study Group

Condition: Condition - Unresectable advanced or recurrent invasive mucinous adenocarcinoma of the lung Classification by malignancy - Malignancy Genomic information - YES

Objective: Narrative objectives1 - To evaluate the efficacy and safety of immune checkpoint inhibitor-based therapy in patients with unresectable advanced invasive mucinous adenocarcinoma of the lung. In particular, this study aims to evaluate the efficacy of combination therapy with cytotoxic chemotherapy and immune checkpoint inhibitors as first-line treatment. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1.Patients diagnosed on or after January 1, 2011, with histopathological findings consistent with invasive mucinous adenocarcinoma (IMA) and no other more appropriate histological subtype. 2.Patients with unresectable clinical stage III or IV disease, or recurrence after surgical resection or definitive (chemo)radiotherapy. Clinical stage is classified according to the 8th edition of the UICC TNM classification. 3.Patients who initiated first-line systemic therapy between January 1, 2011 and September 30, 2025. Key exclusion criteria - 1.Patients who received neoadjuvant or adjuvant chemotherapy, or consolidation therapy after chemoradiotherapy, and initiated first-line treatment for recurrence within 6 months after the last administration of the preceding therapy. 2.Patients considered inappropriate for inclusion in the study by the investigator. 3.Patients who expressed refusal to participate in the study. Target Size - 350

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 01 Month 14 Day Date of IRB - 2026 Year 07 Month 21 Day Anticipated trial start date - 2026 Year 01 Month 14 Day Last follow-up date - 2026 Year 01 Month 14 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071635

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