NCT06424821

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• NSCLC

Interventions

Type	Name	Description
DRUG	Cadonilimab	Cadonilimab + chemotherapy

Timeline

• Start date: 2023-07-04
• Primary completion: 2024-09-04
• Completion: 2025-09-04
• First posted: 2024-05-22
• Last updated: 2024-05-22

Locations

2 sites across 1 country: China