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A Study of Nivolumab +/- Nab-paclitaxel in Non-small Cell Lung Cancer

Nonsmall Cell Lung Cancer Clinical Trial

Official title:
Nivolumab With or Without Nab-Paclitaxel in Previously Treated, Advanced Stage, Non-small Cell Lung Cancer: A Randomized Phase II Study

Clinical Trial Summary

The optimal prioritization of second-line chemotherapy and immune therapy based on demographic or biomarker data is an area of ongoing investigation. The hypothesis of this study is that there may be an additive or synergistic antitumor effect of combined chemotherapy and nivolumab in the second-line treatment of NSCLC as an important concept to test in a clinical trial. Previously treated NSCLC remains a setting of unmet clinical need despite recent clinical research progress. Early progression for a subset of NSCLC patients receiving nivolumab is a specific area of clinical need.

Clinical Trial Description

Nab-paclitaxel will be added to standard nivolumab therapy in previously treated advanced stage non-small cell lung cancer to help prevent early progression and to improve progression free survival. The primary endpoint will be to determine if the addition of nab-paclitaxel to nivolumab improves progression free survival compared to nivolumab alone. Retrospective studies will be conducted to analyze blood based immune biomarkers, and tumor biomarkers to better understand the effect that nivolumab combined with chemotherapy has on the immune system in NSCLC. Patients with advanced stage non-small cell lung cancer who have progression of cancer after receiving platinum doublet chemotherapy will be randomized to receive nivolumab with or without nab-paclitaxel. Patients on both arms will receive a maximum of one year of therapy with the option to retreat at progression. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02967133
Study type Interventional
Source Alliance Foundation Trials, LLC.
Contact
Status Terminated
Phase Phase 2
Start date December 2016
Completion date January 2018
View Details
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