NCT06335355

A Phase II/III Study of Adebrelimab in Combination With SHR-8068 and Chemotherapy in Advanced or Metastatic NSCLC Patients

A Phase II/III, Randomized, Open-label, Parallel-controlled, Multicenter Study of Adebrelimab (SHR-1316) in Combination With SHR-8068 and Platinum-based Doublet Chemotherapy as First-line Treatment in Advanced or Metastatic NSCLC Patients With STK11/KEAP1/KRAS Mutations

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 401 (estimated)
• Sponsor: Shanghai Shengdi Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Evaluating the Efficacy and safety of Adebrelimab in Combination with Platinum-based Doublet Chemotherapy and SHR-8068 as First-line Therapy for Patients with Advanced or Metastatic NSCLC Carrying STK11/KEAP1/KRAS Mutations

Conditions

• Non-squamous Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Adebrelimab + SHR-8068 + Pemetrexed + Carboplatin	Adebrelimab,1200mg; SHR-8068, 1.0 mg/kg; Pemetrexed, 500mg/m2; Carboplatin, AUC 5 mg/mL/min
DRUG	Camrelizumab + Pemetrexed + Carboplatin	Camrelizumab,200mg;Pemetrexed, 500mg/m2; Carboplatin, AUC 5 mg/mL/min
DRUG	Adebrelimab + Pemetrexed + Carboplatin	Adebrelimab,1200mg; Pemetrexed, 500mg/m2; Carboplatin, AUC 5 mg/mL/min

Timeline

• Start date: 2024-03-01
• Primary completion: 2028-10-01
• Completion: 2030-10-01
• First posted: 2024-03-28
• Last updated: 2024-03-28

Locations

1 site across 1 country: China