At a glance
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A Phase 1/2 Study of Combination Immunotherapy and mRNA Vaccine in Subjects With Non-small Cell Lung Cancer (NSCLC)
In Brief
A Phase 2 clinical trial evaluating Durvalumab, Tremelimumab, and 2 other interventions for Metastatic Non-small Cell Lung Cancer and NSCLC. Completed, enrolled 61 participants across 5 sites.
Detailed Summary
This is an open-label, multicenter, 2-arm study to evaluate the safety and preliminary efficacy of the addition of a vaccine therapy to 1 or 2 checkpoint inhibitors for NSCLC. Arm A: messenger ribonucleic acid (mRNA) Vaccine \[BI 1361849 (formerly CV9202)\] + anti-programmed death ligand 1 (PD-L1) antibody \[durvalumab\] Arm B: messenger ribonucleic acid (mRNA) Vaccine \[BI 1361849\] + anti-programmed death ligand 1 (PD-L1) \[durvalumab\] + anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody \[tremelimumab\] The run-in evaluation phase is followed by an expansion phase in which the cohort is expanded to 20 subjects (inclusive of subjects from the run-in).
Study Details
Timeline
Interventions
anti-PD-L1
anti-CTLA-4
mRNA Vaccine
The PharmaJet Tropis® device was used for the intradermal administration of the BI 1361849 vaccine components.