NCT06714708

Low Dose Radiotherapy Combined With Sintilimab and Chemotherapy as Neoadjuvant Therapy for Stage II-III NSCLC

SPARK: Safety and Efficacy of Low Dose Radiotherapy Combined With Sintilimab and Platinum Based Chemotherapy as Neoadjuvant Therapy for Stage II-III Non-Small Cell Lung Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 86 (estimated)
• Sponsor: Anhui Provincial Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate efficacy and safety of low dose radiotherapy combined with sintilimab and platinum based chemotherapy as neoadjuvant therapy for stage II-III Non-Small Cell Lung Cancer

Conditions

• NSCLC
• Neoadjuvant Immunotherapy
• Low Dose Radiotherapy
• Sintilimab

Interventions

Type	Name	Description
RADIATION	Experimental	Radiation: 30Gy/15F Drug: Sintilimab, 200mg IV D1 Q3W Drug: Cisplatin, 75mg/m2 D1 IV Q3W or Carboplatin AUC 5-6mg/ml/min D1 IV Q3W Drug: Pemetrexed, 500mg/m2 D1 IV Q3W or Albumin paclitaxel 260mg/m2，D1 or 130mg/m2，D1,8 IV Q3W
DRUG	Active comparator	Drug: Sintilimab, 200mg IV D1 Q3W Drug: Cisplatin, 75mg/m2 D1 IV Q3W or Carboplatin AUC 5-6mg/ml/min D1 IV Q3W Drug: Pemetrexed, 500mg/m2 D1 IV Q3W or Albumin paclitaxel 260mg/m2，D1 or 130mg/m2，D1,8 IV Q3W

Timeline

• Start date: 2024-11-20
• Primary completion: 2026-12-01
• Completion: 2027-06-01
• First posted: 2024-12-04
• Last updated: 2025-02-10

Locations

1 site across 1 country: China