Study protocol: A single-arm, multicenter, phase II trial of camrelizumab plus apatinib for advanced nonsquamous NSCLC previously treated with first-line immunotherapy

Abstract

Background: For advanced nonsquamous non-small cell lung cancer (NSCLC), the mechanisms of resistance to first-line immunotherapy are not clear. Immune checkpoint inhibitors (ICIs) in combination with agents targeting other pathways may serve as second-line therapy options. Apatinib (a vascular endothelial growth factor receptor 2 tyrosine kinase inhibitor) could increase the efficacy of camrelizumab (an ICI agent). The efficacy and safety of this combination regimen as a second-line therapy for NSCLC patients after failure on first-line immunotherapy has not previously been evaluated.

Methods: In this single-arm, multicenter, phase II trial, metastatic nonsquamous NSCLC patients previously treated with single-agent ICI or ICI plus chemotherapy will be enrolled. Participants will receive intravenous camrelizumab 200 mg D1 and oral apatinib 250 mg D1-21 for a 21-day cycle. The study treatment will continue until disease progression, unacceptable toxicity, or withdrawal of consent. The primary endpoint is progression-free survival by investigator. Secondary endpoints are overall survival, objective response rate, disease control rate, duration of response by investigator, quality of life, safety, and toxicity.

Conclusions: This trial will provide evidence of the benefit of treatment with camrelizumab combined with apatinib in advanced nonsquamous NSCLC patients who were previously treated with first-line immunotherapy.

Trial registration: ClinicalTrials.gov NCT04670913 NCT03689855 NCT04471428 NCT03976375.

Keywords: apatinib; camrelizumab; immune checkpoint inhibitors; non-small cell lung cancer; second-line treatment.