drugset / Trial / NCT05741021

A Phase II Study of Rulonilimab Combined With Chemotherapy in the First-Line Treatment for Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

NCT05741021

Phase 2 Unknown 84 enrolled Shandong New Time Pharmaceutical Co., LTD
NaSingle-groupOpen-labelTreatment

Summary

This is a single-arm, open-label, and multicenter phase Ⅱ study designed to evaluate the efficacy and safety of rulonilimab combined with chemotherapy in patients with advanced or metastatic non-small cell lung Cancer (NSCLC). Two cohorts were designed in this study: cohort 1 (non-squamous NSCLC) and cohort 2 (squamous NSCLC). About 84 patients with advanced or metastatic NSCLC plan to be enrolled in about 20 study sites of the study.

Timeline

Start
2023-03-01
Primary completion
2024-10-25
Completion
2024-10-25

Drugs

EvaluationDrugModalityDoseRoute
Subject F520 Monoclonal antibody 200 mg Intravenous
Background Carboplatin Small molecule Intravenous
Background Paclitaxel Small molecule Intravenous
Background Pemetrexed Small molecule Intravenous