Camrelizumab combined with apatinib and nanoparticle albumin-bound paclitaxel in lung adenocarcinoma (CAPAP-lung): a single-arm phase II study

Background Platinum -doublet chemotherapy plus immunotherapy has been the standard of care for the first -line treatment of advanced non -small cell lung cancer lacking actional driver mutations. However, optimization of drug combinations is still needed to find a better balance between therapeutic efficacy and safety in the immunotherapy era. We aimed to investigate the efficacy and safety of platinum -free albumin bound paclitaxel (nab-paclitaxel) combined with camrelizumab and apatinib as first -line treatment for patients with advanced lung adenocarcinoma. fMethods In this multicenter open -label, single -arm phase II trial, patients with systemic treatment -naive advanced lung adenocarcinoma without epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutations received a rational -based combination of camrelizumab (200 mg intravenously, day one), apatinib (250 mg, q.d., five continuous days per week), and nab-paclitaxel (135 mg/m2 intravenously, days one and eight) every three weeks for four to six cycles in China. Patients with controlled disease were maintained with camrelizumab and apatinib. The primary end point was progression -free survival (PFS). This trial is registered with ClinicalTrials.gov (No. NCT04459078). Findings Between August 26, 2020 and May 20, 2022, 64 patients were enrolled. The median PFS was 14.3 (95% CI: 9.9, not reached) months. The confirmed objective response rate was 64.1% (95% CI: 51.1, 75.7). The grade 3-4 hematologic treatment -related adverse events (TRAEs) were decreased neutrophil count (14.1%), decreased white blood cell count (7.8%), and anemia (3.1%). The most common non -hematologic TRAEs of grade 3-4 were increased alanine transaminase (18.8%) and aspartate transaminase (15.6%). No treatment -related death occurred. The quality of life was on average not clinically meaningful worse through treatment cycle 14. Interpretation Nab-paclitaxel plus camrelizumab and apatinib showed clinically meaningful anti -tumor activity and manageable safety, with few hematologic toxicities, and might be a potential treatment option in patients with advanced lung adenocarcinoma lacking EGFR/ALK mutations.