Concurrent Neoadjuvant Chemoradiotherapy Plus Durvalumab (MEDI4736) in Resectable Stage II
Combination treatment of Durvalumab with chemoradiotherapy is ongoing for head/neck cancer, renal cell carcinoma, melanoma, and non-small cell lung cancer (NCT02318771) and pancreatic cancer (NCT02305186).Combining Durvalumab with neoadjuvant chemoradiotherapy is a promising strategy to improve clinical outcome in stag
| Condition(s) | Potentially Resectable Stage II/IIIa NSCLC |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | Combination treatment of Durvalumab with chemoradiotherapy is ongoing for head/neck cancer, renal cell carcinoma, melanoma, and non-small cell lung cancer (NCT02318771) and pancreatic cancer (NCT02305186).Combining Durvalumab with neoadjuvant chemoradiotherapy is a promising strategy to improve clinical outcome in stage III lung cancer. Using serial biopsied and surgically resected fresh tissue through the novel/high-throughput RNA sequencing technologies, we want to identify the change immune signature in tumor microenvironment of NSCLC patients after Durvalumab treatment. With hypothesis that PD-1 inhibitor as a component of neoadjuvant chemoradiotherapy followed by surgery could increase complete pathologic response rate and disease free survival, and overall survival, we suggest adding |
| Who can participate | Inclusion Criteria: For inclusion in the study subjects must fulfill all of the following criteria: 1. Histologically confirmed NSCLC 2. Clinical stage III (including N2 stage and potential candidate for resection) 3. Written informed consent and any locally-required authorization (IRB) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations 4. Age \> 20 years at time of study entry 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 6. Adequate normal organ and marrow function as defined below: * Haemoglobin ≥ 9.0 g/dL * Absolute neutrophil count (ANC) ≥ 1,500μL * Platelet count ≥ 100,000μL * Serum bilirubin ≤ 1.5 x institutional upper limit of normal (ULN). \<This will not apply to subjects with confirmed Gilber |
| Ages | 20 Years |
| Sex | All |
| Lead sponsor | Yonsei University |
| Locations | Seoul, Seoul, South Korea |
| Start date | 2019-02-12 |
| NCT ID | NCT03694236 |
| Official listing | https://clinicaltrials.gov/study/NCT03694236 |