Phase Ib clinical study of first-line treatment with gefitinib in combination with bevacizumab and chemotherapy in advanced non-squamous non-small cell lung cancer with EGFR mutation.

8554 Background: The safety and efficacy of combination of gefitinib with chemotherapy and bevacizumab in treatment patients with epidermal growth factor receptor (EGFR) mutations are currently unknown. This phase Ib clinical trial was designed to evaluate the safety and preliminary efficacy of a combination therapy consisting of gefitinib, bevacizumab, pemetrexed, and carboplatin in patients with advanced non-squamous non–small cell lung cancer (NSCLC) harboring EGFR mutations. Methods: Eligible patients with EGFR-mutated advanced non-squamous NSCLC were recruited and received gefitinib combination with bevacizumab plus pemetrexed and carboplatin treatment. The primary endpoints were safety and progression-free survival (PFS). Secondary endpoints included objective response rate (ORR), disease control rate (DCR), duration of response (DOR), and overall survival (OS). Results: From June 2019 to June 2021, 20 patients were enrolled in this trial. The median follow-up was 33.8 months (95% CI, 31.0-36.6). Grade ≥3 adverse events was 65%, including neutropenia (30%), thrombocytopenia (20%), nausea (20%), skin rash (20%), bleeding (10%), and increased ALT (10%). There was no death related to toxicity occurred. The median PFS was 28 months (95% CI, 20.4-35.6). the ORR was 95% (95% CI, 75.1%-99.9%), the DCR was 100% (95% CI, 83.2%-100%), and the median DOR was 26.4 months (95% CI, 18.9-33.9). The median OS has not been reached. Conclusions: The results of this study demonstrate that the four-drug combination regimen, led by gefitinib, is well-tolerated and effective for patients with EGFR-mutated advanced non-squamous NSCLC.