A Phase 2 Clinical Trial of Combination Nivolumab, Ipilimumab, and Paclitaxel in Patients With Untreated Metastatic NSCLC: The OPTIMAL Trial.

ABSTRACT:

Introduction

Most patients with advanced NSCLC will experience disease progression and death within 2 years. Novel approaches are needed to improve outcomes.

Methods

We conducted an open-label, nonrandomized, phase 2 trial in patients with treatment-naive, advanced NSCLC to assess the safety and efficacy of nivolumab 360 mg every 3 weeks, ipilimumab 1 mg/kg every 6 weeks, and four to six cycles of paclitaxel 80 mg/m² on days 1 and 8 of every 21-day treatment. The primary end point of the study was median progression-free survival (PFS), with secondary end points of safety, objective response rate, and median overall survival (OS).

Results

A total of 46 patients underwent consent and received treatment. The median age was 66 (range: 48-82) years, most had ad

SUBMITTER: Clarke JM 

PROVIDER: S-EPMC9204732 | biostudies-literature | 2022 Jun

REPOSITORIES: biostudies-literature