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Phase II Clinical Trial of NIVO-IPI-TAXANE in Untreated Metastatic NSCLC

NCT03573947 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2025-10-14

Study results available
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Summary

This is an open-label, non-randomized, phase II clinical research study designed to assess the safety and efficacy of nivolumab and ipilimumab in combination with paclitaxel in patients with treatment naïve NSCLC.

Conditions

Interventions

DRUG

Nivolumab

360 mg intravenously every 3 weeks

DRUG

Ipilimumab

1 mg/kg intravenously over 30 minutes

DRUG

Paclitaxel

80 mg/m2 on days 1 and 8 of every 21-day treatment cycle

Sponsors & Collaborators

  • Jeffrey Clarke

    lead OTHER

Principal Investigators

  • Jeffrey Clarke, MD · Duke University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-02
Primary Completion
2023-03-12
Completion
2023-06-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT03573947 on ClinicalTrials.gov