NCT04728724

Neoadjuvant Immunotherapy for Stage III Non-small Cell Lung Cancer

Neoadjuvant Sintilimab or Combined With Chemotherapy for Stage III Driven Gene Mutation Negative Non-small Cell Lung Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II, non-randomized, open-label, multi-center study to evaluate the efficacy of neoadjuvant Sintilimab (PD-1 antibody) or combined with chemotherapy as first-line treatment in patients with stage III non-small cell lung cancer (NSCLC).

Conditions

• Non-small Cell Lung Cancer Stage III

Interventions

Type	Name	Description
DRUG	Sintilimab	Neoadjuvant treatment stage: Sintilimab 200mg, q3w, i.v., 2-4 cycles, then receive chest CT evaluation. Surgery stage: the patients will receive radical surgery after the neoadjuvant treatment. Adjuvant treatment stage: according to the NCCN guidelines.
DRUG	Chemotherapy	Neoadjuvant treatment stage: Sintilimab 200mg, q3w, i.v., 2-4 cycles; platinum-based chemotherapy (Non-squamus: Carboplatin AUC 5 + Pemetrexed 500mg/m2; Squamous: Carboplatin AUC 5 + Gemcitabine 1000mg/m2 or Paclitaxel 200mg/m2) q3w, i.v., 2-4 cycles, then receive chest CT evaluation. Surgery stage: the patients will receive radical surgery after the neoadjuvant treatment. Adjuvant treatment stage: according to the NCCN guidelines.

Timeline

• Start date: 2022-09-10
• Primary completion: 2023-09-15
• Completion: 2027-12-31
• First posted: 2021-01-28
• Last updated: 2023-09-13

Locations

1 site across 1 country: China