advanced or recurrent pulmonary large cell neuroendocrine carcinoma
Conditions
Interventions
None listed
Sponsors
Department of Respiratory Medicine, Kobe University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient characteristics (PD-L1 status, Performance Status, age, sex, smoking history, comorbidities, and stage at diagnosis); molecular subtypes assessed by HE, RB1, TP53, ASCL1, NEUROD1, POU2F3, YAP1, CD4, CD8, and DLL3; Overall Survival (OS); safety (incidence and severity of adverse events); and molecular subtypes in patients with Progression-Free Survival (PFS) of 12 months or longer. | — |
Countries
Japan
Contacts
Public ContactMariko Okamoto
Kobe University Hospital Department of Respiratory Medicine
Outcome results
None listed