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Spots Global Cancer Trial Database for Phase II Trial of Sequential Consolidation With Pembrolizumab Followed by Nab-paclitaxel

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We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Phase II Trial of Sequential Consolidation With Pembrolizumab Followed by Nab-paclitaxel

Official Title: Phase II Trial of Sequential Consolidation With Pembrolizumab Followed by Nab-paclitaxel After Standard First-Line Induction Chemotherapy in Advanced NSCLC

Study ID: NCT02684461

Interventions

Pembrolizumab

Study Description

Brief Summary: The purpose of this research study is to test the effectiveness of three treatment arms that are designed to improve survival in patients with non-small cell lung cancer. Eligible subjects could be randomized to four (4) cycles of chemotherapy followed by immunotherapy, or immunotherapy followed by chemotherapy, or four cycles of chemotherapy plus immunotherapy.

Detailed Description: This open-label, three-arm, non-comparative randomized phase II study is designed to evaluate three different sequences of double-consolidation with the humanized monoclonal antibody targeted against cell surface receptor programmed cell death-1 (PD-1), pembrolizumab, and nab-paclitaxel in patients with advanced Non small cell lung cancer post induction chemotherapy. While the goal of each arm is to guarantee exposure to each of these two agents to patients who have not progressed post induction chemotherapy, they do so with different sequence. In ARMs A and B, consolidation is sequential, with either pembrolizumab followed by nab-paclitaxel (ARM A), or nab-paclitaxel followed by pembrolizumab (ARM B). In ARM C, consolidation is concurrent, with the two agents administered concurrently. As of July 24, ARMs B and C are closed, and no patients will be enrolled on this study. ARM A remains open to enrollment.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

UNC Lineberger Comprehsive Cancer Center, Chapel Hill, North Carolina, United States

Rex Cancer Center, Raleigh, North Carolina, United States

Rex Cancer Center of Wakefield, Raleigh, North Carolina, United States

UT Southwestern Medical Center, Dallas, Texas, United States

Inova Schar Cancer Institute, Fairfax, Virginia, United States

Contact Details

Name: Jared Weiss, MD

Affiliation: University of North Carolina, Chapel Hill

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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