NCT06667154

Efficacy Analysis of Neoadjuvant Treatment in Lung Cancer Using Low-dose Nivolumab Combined With Chemotherapy

Efficacy Analysis of Neoadjuvant Treatment in Lung Cancer Using Low-Dose Nivolumab Combined With Chemotherapy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Aline Fusco Fares, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to assess the major pathological response (MPR) rate and pathologic complete response (pCR) rate in stage IB-IIIA non-small cell lung cancer (NSCLC) treated with a low dose of neoadjuvant immunotherapy combined with platinum doublet.

Conditions

• Lung Cancer, Nonsmall Cell
• Non-Small Cell Lung Cancer NSCLC

Interventions

Type	Name	Description
DRUG	Low-dose nivolumab combined with platinum-based doublet chemotherapy	Platinum-based neoadjuvant chemotherapy (carboplatin at AUC 5 or 6 combined with either paclitaxel at 175 mg/m² or pemetrexed at 500 mg/m²), administered with nivolumab at 0.3 mg/kg every 21 days for 3 cycles.

Timeline

• Start date: 2023-10-10
• Primary completion: 2025-10-31
• Completion: 2027-10-31
• First posted: 2024-10-31
• Last updated: 2024-10-31

Locations

1 site across 1 country: Brazil

Regulatory

• FDA-regulated drug study