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

Sponsor
Spanish Lung Cancer Group
Study ID
NCT03081689
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab 360 mg — DRUG
    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
  • Paclitaxel 200mg/m2 — DRUG
    Paclitaxel 200mg/m2 IV Q3W
  • Carboplatin AUC 6 — DRUG
    Carboplatin AUC 6 IV Q3W

Study Details

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.

Key Dates

Start date
Apr 15, 2017
Status verified
Nov 2024
Primary completion
Sep 15, 2023
Completion
Oct 18, 2023

Study Design

Enrollment
46 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    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

Primary Outcome Measure

Progression Free Survival [ Time Frame: at 24 months from the first dose of neoadjuvant treatment ]

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