OncRef

Clinical Trial: NCT03081689

Neo-Adjuvant Immunotherapy With Nivolumab for Non Small Cell Lung Cancer Patients

Status:

COMPLETED

Phase:

Phase 2

Lead Sponsor:Spanish Lung Cancer Group
Information Provided By:Spanish Lung Cancer Group
Last Update Posted:2024-12-04

Study Overview

Brief Summary

Phase II, single-arm, open-label multicenter study that assesses feasibility, safety and efficacy of combined neoadjuvant chemotherapy and immunotherapy with Nivolumab 360 mg IV Q3W + Paclitaxel 200mg/m2 + Carboplatin AUC 6 IV Q3W in resectable stage IIIA N2-NSCLC adult patients followed by adjuvant treatment for 1 year with Nivolumab 240 mg IV Q2W for 4 months and Nivolumab 480mg Q4W for 8 months.

Official Title

Neo - Adjuvant Chemo / Immunotherapy for the Treatment of Resectable Stage IIIA Non Small Cell Lung Cancer (NSCLC): A Phase II Multicenter Exploratory Study

Conditions

Non Small Cell Lung Cancer

Intervention / Treatment

  • Drug: Nivolumab 360 mg
  • Drug: Paclitaxel 200mg/m2
  • Drug: Carboplatin AUC 6

Other Study ID Numbers

  • GECP 16/03_NADIM

Start Date (Actual)

2017-04-15

Primary Completion Date (Actual)

2023-09-15

Study Completion Date (Actual)

2023-10-18

Enrollment (Actual)

46

Study Type

Interventional

Phase

Phase 2