Efficacy Analysis of Neoadjuvant Treatment in Lung Cancer Using Low-dose Nivolumab Combined With Chemotherapy
- Sponsor
- Aline Fusco Fares, MD
- Study ID
- NCT06667154
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Lung Cancer, Nonsmall Cell
- Non-Small Cell Lung Cancer NSCLC
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Low-dose nivolumab combined with platinum-based doublet chemotherapy — DRUGPlatinum-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.
Study Details
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.
Key Dates
- Start date
- Oct 10, 2023
- Status verified
- Oct 2024
- Primary completion
- Oct 31, 2025
- Completion
- Oct 31, 2027
Study Design
- Enrollment
- 33 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Low-dose nivolumab combined with platinum-based doublet chemotherapy
Primary Outcome Measure
Major Pathologic Response [ Time Frame: 2-3 months ]
Central Contacts
- JOAO A SOLER, MD+55 17 981350180
- ALINE FARES, MD
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