Effect of angiotensin II receptor blockers on efficacy and safety of Camrelizumab plus chemotherapy in the first-line therapy for advanced non-small cell lung cancer (ARMOR I): a protocol for a prospective, real-world, multicenter, intervention clinical trial.

BACKGROUND

Lung cancer, particularly non-small cell lung cancer (NSCLC), remains a leading cause of cancer-related mortality worldwide. While immune checkpoint blockade (ICB), such as PD-1/PD-L1 inhibitors, have revolutionized treatment for advanced NSCLC, not all tumor patients respond to ICB therapy. Our recent investigations highlight the role of collagens synthesized by cancer-associated fibroblasts (CAFs) in immune evasion. Angiotensin II receptor blocker (ARB) has shown potential in reshaping the tumor microenvironment (TME) by inhibiting collagens, making tumors more susceptible to immunotherapy. This study aims to evaluate the effect of ARB on the efficacy and safety of Camrelizumab, an anti-PD-1 antibody, in combination with chemotherapy for first-line treatment of advanced NSCLC.

METHODS

The ARMOR I trial is a prospective, real-world, multicenter, intervention clinical study designed to assess the synergistic effect of ARBs on Camrelizumab plus chemotherapy in patients with advanced NSCLC. Eligible patients include those with stage IV or unresectable locally advanced NSCLC, who have been diagnosed with hypertension and are receiving standard treatment for it. The study will enroll approximately 180 patients over a 12-month recruitment period, with a 12-month follow-up phase. The primary endpoint is the objective response rate (ORR), with secondary endpoints including progression-free survival (PFS), overall survival (OS), and safety.

DISCUSSION: The interplay between collagens, ARB, and cancer is still complex and worth further study. ARMOR I will provide crucial preliminary data on ARB's role in first-line therapy for advanced NSCLC. The potential application of ARB in other tumor types may also become an important area to explore.