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

NCT03081689 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2024-12-04

Study results available
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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.

Conditions

  • Non Small Cell Lung Cancer

Interventions

DRUG

Nivolumab 360 mg

Nivolumab 360 mg IV Q3W + Followed by adjuvant treatment for 1 year with Nivolumab 240 mg IV Q2W for 4 months and Nivolumab 480mg Q4W for 8 months

DRUG

Paclitaxel 200mg/m2

Paclitaxel 200mg/m2 IV Q3W

DRUG

Carboplatin AUC 6

Carboplatin AUC 6 IV Q3W

Sponsors & Collaborators

  • Spanish Lung Cancer Group

    lead OTHER

Principal Investigators

  • Mariano Provencio, MD · spanish Lun Cancer Group

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-15
Primary Completion
2023-09-15
Completion
2023-10-18

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03081689 on ClinicalTrials.gov