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)

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)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Shandong New Time Pharmaceutical Co., LTD · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-small Cell Lung Cancer
• NSCLC
• PD-1

Interventions

Type	Name	Description
DRUG	F520	F520 is a recombinant, humanized programmed death receptor-1 (PD-1) monoclonal antibody that binds to PD-1 and prevents binding of PD-1 with programmed death ligands 1 (PD-L1) and 2 (PD-L2).
DRUG	Pemetrexed	A chemotherapy medication used to treat a number of types of cancer.
DRUG	Carboplatin	A chemotherapy medication used to treat a number of types of cancer.
DRUG	Paclitaxel	A chemotherapy medication for the treatment of pleural mesothelioma and non-small cell lung cancer (NSCLC).

Timeline

• Start date: 2023-03-01
• Primary completion: 2024-10-25
• Completion: 2024-10-25
• First posted: 2023-02-23
• Last updated: 2023-02-24

Locations

1 site across 1 country: China