Cadonilimab Plus Chemotherapy as First-line Treatment for PD-L1 Negative NSCLC — LungCadX  

NSCLC Clinical Trial

Official title: A Phase II Clinical Study of Cadonilimab in Combination With Chemotherapy as First-Line Treatment for PD-L1 Negative Advanced Non-Small Cell Lung Cancer

Status Recruiting

Clinical Trial Summary

The goal of this clinical trial is to investigate the efficacy, safety and tolerability of PD-1/CTLA-4 inhibitor (Cadonilimab) combination with chemotherapy as first-line treatment for PD-L1 negative advanced non small cell lung cancer patients. And also explore the potential biomarkers for predicting the efficacy of PD-1/CTLA-4 inhibitor for advanced non small cell lung cancer.

Clinical Trial Description

LungCadX is a multi-center, open-label, single-arm, investigator initiated, phase Ⅱ study. Patients received cadonilimab (10 mg/kg, IV, every 3 weeks) plus platinum-based chemotherapy (carboplatin [area under the curve (AUC) 5 mg/mL per min, IV] and paclitaxel [175 mg/m2, IV] for squamous NSCLC, or carboplatin [AUC 5 mg/mL per min, IV] and pemetrexed [500 mg/m2, IV] for non-squamous NSCLC) for up to four cycles, followed by maintenance therapy with cadonilimab for squamous NSCLC, and intravenous cadonilimab plus pemetrexed for non-squamous NSCLC. The primary endpoint was 12-month PFS rate by investigator assessment per RECIST 1.1. Secondary endpoints included PFS, OS, ORR，DoR，DCR, and the safety. Exploratory objective was to assess blood/tumor/urine/faeces tissue for potential biomarkers study. Adverse events will be monitored throughout the trial and graded according to the CTCAE v5.0. ;

Related Conditions & MeSH terms

• NSCLC

• NCT number: NCT06424821
• Study type: Interventional
• Source: Shanghai Pulmonary Hospital, Shanghai, China
• Contact: Li Wang
• Phone: 18170211997
• Email: leewang8023@126.com
• Status: Recruiting
• Phase: Phase 2
• Start date: July 4, 2023
• Completion date: September 4, 2025