Abstract 128P
Background
Stage III non-small cell lung cancer (NSCLC) is highly heterogeneous with great variations in clinical practice. Though neoadjuvant immunotherapy plus chemotherapy significantly improved pCR and EFS in resectable NSCLC patients compared with chemotherapy alone in previous study, the evidence in stage III NSCLC are limited. This is the first study to evaluate durvalumab neoadjuvant/adjuvant in stage III NSCLC patients.
Methods
A prospective phase II, single-arm study enrolled the patients (according to the MDT) with histologically confirmed stage IIIa-IIIc NSCLC without known EGFR/ALK mutations. Patients received neoadjuvant durvalumab (1500mg) plus platinum-based chemotherapy q3w for 2-4 cycles followed by surgery, then adjuvant durvalumab mono q4w for 12 cycles. The primary endpoint was MPR (≤10% viable tumor cells). Secondary endpoints included pCR (0% viable tumor cells), ORR, DFS, OS, and safety. Predictive biomarkers was exploratory endpoint.
Results
From February 7, 2021 to May 30, 2022, a total of 14 patients were enrolled with median follow-up of 9.5 months. The median age was 64.5 and 71.4% were squamous carcinoma histology. The number of patients with stage IIIa, IIIb, IIIc were 2 (14.3%), 10 (71.4%) and 2 (14.3%), respectively. All patients completed neoadjuvant therapy, 6 patients received 3 cycles and 8 patients received 4 cycles. Currently, the ORR was 64.3% (9/14), 10 patients underwent surgery, 4 patients were ineligible for surgery due to 2 with unresectable stage IIIc disease, 1 with tumor wrapping around the right bronchus and 1 with poor lung function. Among 10 resected patients, 50.0% achieved MPR and 20.0% achieved pCR. The TCR clone counts after 1 cycle neoadjuvant therapy was positively corelated with imaging regressions (p=0.044). The median DFS was not reached. Grade 3 or 4 treatment-related adverse events rate was 14.3%.
Conclusions
The results suggest that stage IIIa-IIIb NSCLC can benefit from neoadjuvant Durvalumab plus chemotherapy. Two stage IIIc patients failed to convert from neoadjuvant therapy. TCR diversity is positively correlated with imaging regression, analysis of its correlation with survival outcomes is ongoing.
Clinical trial identification
NCT04897386.
Legal entity responsible for the study
X. Dong.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.