First-line CBDCA/PTX/LEN/Pembrolizumab Combination for Previously Untreated Advanced or Re
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
| Condition(s) | Untreated Advanced or Recurrent Thymic Carcinomas |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | 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 |
| Who can participate | Inclusion Criteria: 1. 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. 2. 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. Or, in the case of stage III Masaoka-Koga classification, patients w |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | National Cancer Center, Japan |
| Locations | Chūō, Tokyo, Japan |
| Start date | 2023-09-04 |
| NCT ID | NCT05832827 |
| Official listing | https://clinicaltrials.gov/study/NCT05832827 |