62MO A randomised, controlled, multicenter phase II trial of camrelizumab combined with albumin-bound paclitaxel and cisplatin as neoadjuvant treatment in locally advanced NSCLC

Camrelizumab (Cam), an anti-PD-1 antibody, could significantly increase the PFS and ORR in advanced non-squamous NSCLC vs chemotherapy (CT). However, the effect and safety of Cam plus CT in the neoadjuvant setting is unknown. This interim analysis included 27 patients (pts) with locally advanced NCSLC. Treatment-naive pts with stage IIIA or IIIB-N2 resectable NSCLC, ECOG PS 0-1, were randomized (1:1) to receive intravenous Cam (200mg) on D1, albumin-bound paclitaxel (ab-Pac; 130 mg/m2) on D1 and 8, and cisplatin (Cis; 75 mg/m2) on D1 (Cam+CT group), or ab-Pac plus Cis (CT group) of a 21-day cycle for 3 cycles. Treatment was followed by surgery. The primary endpoint was pathologic complete response (pCR). Secondary endpoints included major pathologic response (MPR), ORR, DFS by RECIST 1.1, and safety. The immune-related gene profiles of pre- or post-treatment biopsies and serum were detected to construct the individualized immune signature for outcome prediction through a multicenter analysis. 94 patients were planned to be enrolled. At data cutoff (Sept 15, 2020), 27 pts were enrolled (14 in the Cam+CT group and 13 in the CT group). All pts received at least 1 cycle treatment. 14 pts completed neoadjuvant therapy and efficacy evaluation, among which 13 had surgery (7 in the Cam+CT group and 6 in the CT group) and 1 was pending for surgery. In the Cam+CT group, pCR was observed in 4/7 (57.1%) pts and MPR in 2 (28.6%); ORR was 86.7% (6/7; CR: 1, PR: 5). In the CT arm, 1/6 (16.7%) pts achieved pCR and 1 (16.7%) had MPR; ORR was 57.1% (4/7; CR: 1, PR: 3). DFS data was immature and gene profiles will be analyzed later. Adverse events (AEs) of the two arms were similar, except reactive cutaneous capillary endothelial proliferation (9/14 [64.3%]; all grade 1) in the Cam+CT arm. No AEs beyond expectation or of grade 4-5 were reported. These interim results suggested camrelizumab plus CT may have a better effect as neoadjuvant therapy in locally advanced NSCLC. This trial is ongoing and final analysis will be conducted after study completion.