Last updated on April 2017

Study of OSE2101 Versus Standard Treatment as 2nd or 3rd Line in HLA-A2 Positive Patients With Advanced NSCLC

Brief description of study

The aim of this study is to determine if the Investigational Medicinal Product Tedopi (OSE2101) is more effective than standard treatment in treating patients with stage IIIB NSCLC unsuitable for radiotherapy or metastatic NSCLC in second- or third-line treatment.

Detailed Study Description

The aim of this study is to demonstrate that OSE2101 (Arm A) is superior to standard chemotherapy, pemetrexed or docetaxel (Arm B), in prolonging overall survival (OS) in HLA-A2 positive patients with locally advanced (IIIB) or metastatic NSCLC as 2nd line therapy after failure of prior platinum-based chemotherapy or 3rd line after failure of platinum- and checkpoint-inhibitor regimens. In Arm B, patients with squamous NSCLC are allocated to docetaxel and patients with non-squamous NSCLC are allocated to pemetrexed if they are pemetrexed-naive or to docetaxel should they have already received pemetrexed. Treatment cycles will be repeated until unequivocal Recist 1.1-defined disease progression as determined by the investigator, unacceptable toxicity, or consent withdrawal.

Clinical Study Identifier: NCT02654587

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Jatin K Desani, MD

Meridian Health
Neptune, NJ United States
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