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Poster Display session (Friday) (ID 65)
- Event: ELCC 2018
- Type: Poster Display session
- Presentations: 1
- Coordinates: 4/13/2018, 12:30 - 13:00, Hall 1
126TiP - SAKK 16/14: Anti-PD-L1 antibody durvalumab (MEDI4736) in addition to neoadjuvant chemotherapy in patients with stage IIIA(N2) non-small cell lung cancer (NSCLC): A multicenter single-arm phase II trial (ID 638)
12:30 - 13:00 | Author(s): M. Gonzalez
Improving the outcome of locally advanced non-small cell lung cancer (NSCLC) is one of the major challenges in thoracic oncology. SAKK substantially contributed to establish a standard of care for patients with stage III NSCLC: The trial SAKK 16/96 established neoadjuvant chemotherapy with three cycles of cisplatin and docetaxel. The randomized trial SAKK 16/00 showed no benefit by adding neoadjuvant radiotherapy as third treatment modality. Our results consistently showed a 5-year overall survival (OS) of 37%. Recently, the PACIFIC trial showed significantly improved progression-free survival for durvalumab as consolidation therapy after definitive chemoradiotherapy in unresectable stage III NSCLC.
This is a single-arm phase II clinical trial designed to evaluate the addition of perioperative immunotherapy with durvalumab to the previously established standard of care for stage IIIA(N2) patients. Eligible patients with WHO performance status 0–1 and age of 18–75 years 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 three cycles of chemotherapy with cisplatin 100 mg/m and docetaxel 85 mg/m 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 data of first 25 operated patients and given that the results showed that their 30-day post-operative mortality is less than 10%, according to the decision rule described in the protocol of the trial there is no reason for further detailed safety analysis (evaluated by an IDMC) and thus shall continue as per protocol.
Clinical trial identification:
Legal entity responsible for the study:
Swiss Group for Clinical Cancer Research
Swiss Group for Clinical Cancer Research; AstraZeneca; Rising Tide Foundation, Gateway for Cancer Research
S.I. Rothschild: SAKK 16/14 study is supported by AstraZeneca. All other authors have declared no conflicts of interest.
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