Abstract: Objective · To evaluate the safety of DCVAC/LuCa combined with pemetrexed/carboplatin in patients with stage Ⅳ non-small cell lung cancer (NSCLC). Methods · A total of 20 newly diagnosed stage Ⅳ , non-squamous, wild-type epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) negative or unknown NSCLC patients were randomized into test group (n10) and control group (n10). Test group received pemetrexed/ carboplatin chemotherapy (4-6 cycles), combined with DCVAC/LuCa treatment in the third cycle, followedpemetrexed monotherapy in combination with DCVAC/LuCa; control group received pemetrexed/carboplatin chemotherapy (4-6 cycles), followedpemetrexed alone. The efficiency of the patientsintwogroups wasevaluated andadverseeffects (AEs)werecollected andanalyzed. Results · Therewas a significantpositivecorrelation between DCVAC/LuCa transfusion dose and progression-free survival (PFS) (r0.773, P0.009). The common AEs in both groups were chemotherapy related leukopenia, hemoglobin decrease etc.AllAEs were grade 1 or 2 according to common terminology criteria for adverse events (CTCAE) V4.03, and there were no grade 4 toxicities or treatment-related deaths. One patient in test group got non-infectious fever and body ache, and returned to normal without treatment. Conclusion · In patients with stage Ⅳ NSCLC, DCVAC/LuCa therapy is well tolerated with the favorable safety.

Key words: dendritic cell, non-small cell lungcancer (NSCLC), safety