A phase II, investigator-initiated, non-randomized, open-label, single-arm, multicenter study to evaluate the efficacy and safety of Carboplatin/Paclitaxel/Lenvatinib/Pembrolizumab combination for previously untreated advanced or recurrent thymic carcinomas
Patients aged 18 years or older at the time of informed consent, who are pathologically (histologically or cytologically) diagnosed with thymic carcinoma for primary or metastatic thymic lesions, are included. They are preferred to be positive for CD5 or c-KIT by immunohistochemical staining. For those with non-squamous epithelial carcinoma negative for p40 or p63, non-primary cases should be excluded based on their clinical and pathological findings. In addition, those with thymoma are excluded.
Patients with unresectable advanced thymic carcinoma (equivalent to stage IVa or IVb of Masaoka-Koga classification), metastatic or recurrent, who have not been treated with systemic cancer chemotherapy.
No symptomatic brain metastases, carcinomatous meningitis, or spinal metastases requiring radiotherapy or surgery
No prior history of an antiangiogenetic agent targeting VEGFR for thymic carcinoma
Has diagnosed as thymomas
Has related immune-related complications such as myasthenia gravis, pure red cell aplasia, or hypogammaglobulinemia
Patients with ECG QT correction interval prolongation or history of such prolongation (patients with QTcF > 480 ms)
Has a LVEF below the institutional normal range, as determined by multigated acquisition (MUGA) or echocardiogram (ECHO)
National Cancer Center, Japan
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator