Tokyo, March 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060326) titled 'A multicenter study evaluating the efficacy of immune checkpoint inhibitor based combination chemotherapy according to molecular subtypes in patients with advanced or recurrent pulmonary large cell neuroendocrine carcinoma' on March 1.

Study Type: Observational

Primary Sponsor: Institute - Department of Respiratory Medicine, Kobe University Hospital

Condition: Condition - advanced or recurrent pulmonary large cell neuroendocrine carcinoma Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - The primary objective of this study is to investigate the efficacy of immune checkpoint inhibitor based combination chemotherapy and to elucidate molecular subtypes in patients diagnosed with advanced or recurrent pulmonary large cell neuroendocrine carcinoma who have received immune checkpoint inhibitor based combination chemotherapy. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Patients with a histologically confirmed diagnosis of advanced or recurrent pulmonary large cell neuroendocrine carcinoma who received immune checkpoint inhibitor based combination systemic therapy as first line treatment. 2. Definition of advanced or recurrent disease. Patients meeting at least one of the following criteria. Patients meeting at least one of the following criteria: - Unresectable stage III disease not amenable to definitive radiotherapy limited to cases in which the radiation field is excessively extensive and definitive radiotherapy is not feasible. Patients for whom chemotherapy was selected due to interstitial lung disease or poor performance status are excluded. - Stage IV disease. - Recurrent disease. Recurrent disease includes the following. - Recurrence after surgical resection. - Recurrence after definitive radiotherapy alone. In patients who received adjuvant chemotherapy after surgery the first systemic chemotherapy administered after recurrence is defined as first line treatment.

3. Pulmonary large cell neuroendocrine carcinoma is defined as meeting all of the following criteria. 1) Morphologically classified as non small cell lung carcinoma lacking features of squamous cell carcinoma and adenocarcinoma. 2) Positive immunohistochemical staining for at least two of the following neuroendocrine markers synaptophysin chromogranin A and CD56. 4. Patients for whom information on clinical course treatment details and prognosis can be obtained from medical records. 5. Patients aged 20 years or older at the time of diagnosis. Key exclusion criteria - 1. Patients who have indicated their refusal to participate in this study based on publicly disclosed study information (opt-out). 2. Patients deemed inappropriate for inclusion in this study by the principal investigator. Target Size - 60

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 03 Month 01 Day Anticipated trial start date - 2026 Year 03 Month 01 Day Last follow-up date - 2027 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068983

Disclaimer: Curated by HT Syndication.