A Study of Nivolumab +/- Nab-paclitaxel in Non-small Cell Lung Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Non Small Cell Lung Cancer Recurrent
- Non-Small Cell Carcinoma of Lung, TNM Stage 4
- Non Small Cell Lung Cancer Metastatic
- Nonsmall Cell Lung Cancer
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 pro...
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.
Tracking Information
- NCT #
- NCT02967133
- Collaborators
- Celgene Corporation
- Bristol-Myers Squibb
- Investigators
- Principal Investigator: Monica Bertagnolli, MD Alliance Foundation Trials, LLC. Study Chair: Neal Ready, MD, PhD Alliance Foundation Trials, LLC.
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