Camrelizumab plus pemetrexed disodium and carboplatin combined with thalidomide as first-line therapy for advanced, non-squamous non-small cell lung cancer: a prospective, single-arm, pilot study

Background The aim of this study was to evaluate whether the addition of thalidomide to camrelizumab plus pemetrexed disodium and carboplatin as first-line treatment would improve therapeutic efficacy in patients with non-squamous non-small cell lung cancer (NSCLC). Methods This prospective, single-arm, pilot study enrolled treatment-naïve patients with advanced non-squamous NSCLC. Patients received intravenous administration of camrelizumab (200 mg), carboplatin (area under curve, 5 mg/mL per min) and pemetrexed disodium (500 mg/m2) on day 1 of each three-week treatment cycle. Meanwhile, all the patients received the maintenance therapy with thalidomide (oral, 50 mg, twice a day). Primary endpoint was progression-free survival (PFS). Results At data cutoff (February 2025), 20 patients (median age 64.0 [Interquartile range, IQR:59.5–68.0]; 80% male) were evaluable. With median follow-up of 28.9 months (95%CI:16.1–45.7), the regimen achieved median overall survival (OS) of 43.3 months (95%CI:16.9–69.7) and PFS of 15.2 months (95%CI:7.6–27.5). Objective responses occurred in 70% (14/20; 95%CI:44.0–81.2%), with disease control in 95% (19/20). Treatment-related adverse events (TRAEs) affected 90% (18/20), predominantly grade 1–2 hypothyroidism (75%) and reactive cutaneous capillary endothelial proliferation (50%). Grade ≥ 3 TRAEs occurred in 5% (only pneumonia, elevated alanine aminotransferase, and rash). Conclusions The first-line treatment of camrelizumab plus pemetrexed disodium and carboplatin combined with thalidomide showed clinically meaningful survival improvement and reduced incidence rate of RCCEP in advanced non-squamous NSCLC patients. Trial registration: Registration number is ChiCTR2000038265, date of registration is 15/09/2020.