Neoadjuvant chemo/immunotherapy for the treatment of stages IIIA resectable non-small cell lung cancer (NSCLC): A phase II multicenter exploratory study—NADIM study-SLCG.

Abstract

8521 Background: The combination of chemotherapy and immunotherapy (CT-IO) has a high response rate and longer survival in unselected patients (pts) with metastatic non-small cell lung cancer (NSCLC). There are no data about this combination in the neoadjuvant setting. Methods: A Phase II, single-arm, open-label multicenter study of resectable stage IIIA N2-NSCLC adult patients with CT plus IO (nivolumab (NV)) followed by adjuvant treatment for 1 year. Neoadjuvant treatment: Three cycles of NV 360mg IV Q3W + paclitaxel 200mg/m2 + carboplatin AUC 6 IV Q3W. After completing neoadjuvant therapy, tumor assessment is performed in patients prior to surgery. Surgery is performed in the 3rd or 4th week after day 21 of the third cycle of neoadjuvant treatment. Adjuvant treatment: nivolumab 240mg IV Q2W for 4 months and nivolumab 480mg IV Q4W for 8 months (total one year) after surgical resection. The study aims to recruit 46 pts. The primary endpoint is Progression-Free Survival (PFS) at 24 months. Efficacy is explored using objective pathologic response criteria. We present preliminary data on patients that completed 3 cycles and underwent surgical assessment. Results: At the time of submission, 30 pts had been included and 13 underwent surgery. CT-IO was well-tolerated and surgery was not delayed in any patient. None of the pts withdrew from the study preoperatively due to progression or toxicity. Thirteen surgeries had been performed and all tumors were deemed resectable. 9 cases (69.2%) achieved complete pathologic response (CPR) (CI 95% 38.6-90.9%), and 2 had a major pathologic response (MPR),defined as < 10% viable tumor cells in the resection specimen. Considering both CPR and MPR, the overall response rate was 84.6% (95% CI 54.6-98.1%). Conclusions: This is the first multicentric study testing CT-IO in the neoadjuvant setting with promising antitumor activity. Neoadjuvant CT-IO with nivolumab in resectable IIIA NSCLC yields a complete pathologic response rate that has never been seen previously. The data will be updated at the time of the congress. EudraCT Number: 2016-003732-20 Clinical trial information: NCT03081689.