NCT05940532

A Trial of Sugemalimab and Chemotherapy in Unresectable Stage III NSCLC

A Single-arm Phase 2 Study of Sugemalimab and Chemotherapy as Induction Therapy in Unresectable and Stage III Non-small Cell Lung Cancer (NSCLC)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (estimated)
• Sponsor: Hunan Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this phase II, open-label, single-arm study is to evaluate the efficacy and safety of induction immunotherapy and chemotherapy followed by the multidisciplinary team (MDT)-guided radiotherapy or surgery in unresectable, stage III non-small cell lung cancer.

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
DRUG	Sugemalimab and Chemotherapy	Chemotherapy: Paclitaxel 175mg/m2 D1, Carboplatin AUC=5 or DDP 75mg/m2 D1 for NSCLC; Pemetrexed 500mg/m2 D1, Carboplatin AUC=5 or DDP 75mg/m2 D1 for non-squamous NSCLC; intravenous infusion every 3 weeks, for up to four cycles. Sugemalimab: 1200 mg by intravenous infusion every 3 weeks, for up to 2 years.

Timeline

• Start date: 2023-06-14
• Primary completion: 2025-01-01
• Completion: 2026-12-01
• First posted: 2023-07-11
• Last updated: 2023-07-11

Locations

1 site across 1 country: China