RecruitingPhase 2NCT06667154

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

Sponsor

Aline Fusco Fares, MD

Enrollment

33 participants

Start Date

Oct 10, 2023

Study Type

INTERVENTIONAL

Conditions

Lung Cancer, Nonsmall Cell

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a lower dose of the immunotherapy drug nivolumab (Keytruda's competitor) combined with standard chemotherapy before surgery can shrink early-to-intermediate stage non-small cell lung cancer (NSCLC). The goal is to reduce the tumor before removing it surgically. **You may be eligible if...** - You are 18 or older with stage IB, II, or IIIA NSCLC - Your tumor is considered operable (surgically removable) - Your tumor does not have EGFR, ALK, or ROS1 mutations - You are in good health (ECOG 0–1) with adequate blood and organ function - You have not received prior cancer treatment for lung cancer **You may NOT be eligible if...** - Your cancer is very early (stage IA) or very advanced (stage IIIB, IV) - Your tumor involves the heart, aorta, or esophagus, or there is bulky lymph node disease - You have had prior chemotherapy, immunotherapy, or biological treatment for lung cancer - You are pregnant or have another active cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGLow-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.