University Hospital Basel, Basel, Switzerland
Sacha Rothschild , Alfred Zippelius , Spasenija Savic , Michel Gonzalez , Walter Weder , Alexandros Xyrafas , Corinne Rusterholz , Miklos Pless
Background: Improving the outcome of locally advanced non-small cell lung cancer (NSCLC) is one of the major challenges in thoracic oncology. Based on previous trials from the Swiss Group for Clinical Cancer Research (SAKK) neoadjuvant chemotherapy with 3 cycles of cisplatin/docetaxel is an accepted standard of care. Recently, the PACIFIC trial showed significantly improved progression-free survival (PFS) for durvalumab as consolidation therapy after definitive chemoradiotherapy in unresectable stage III NSCLC. Here, we give an update on the ongoing trial and present results from a predefined safety evaluation focusing on 30-day post-operative mortality rate. Methods: This is a single-arm phase II clinical trial evaluating the addition of perioperative immunotherapy with durvalumab to the previously established standard of care for stage IIIA(N2) patients. Eligible patients must have pathologically proven NSCLC stage IIIA(N2) (T1-3 N2 M0) according to the 7th edition of the TNM classification, irrespective of histological subtype, genomic aberrations or PD-L1 expression status. Tumor tissue has to be available for the mandatory translational research. Patients whose tumor is deemed resectable at diagnosis receive 3 cycles of chemotherapy with cisplatin 100 mg/m2 and docetaxel 85 mg/m2 every three weeks followed by two cycles of durvalumab 750 mg every two weeks. Following surgery, patients will be treated with durvalumab 750 mg every two weeks for 12 months. The primary endpoint of the trial is event-free survival at 12 months. Secondary endpoints include OS, objective response, nodal down-staging, complete resection, pattern of recurrence and toxicity. Additionally, a large translation research program accompanies the trial investigating potential predictive biomarkers of anti-PD-L1 therapy. Based on the protocol, a first safety evaluation has been done after the first 25 operated patients. This analysis demonstrated a 30-day post-operative mortality of less than 10%. According to the decision rule described in the protocol the trial thus shall continue as per protocol. Clinical trial information: NCT02572843
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Abstract Disclosures
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