Spots Global Cancer Trial Database for Phase 1b DV281 With an Anti-PD-1 Inhibitor in NSCLC

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Trial Identification

Brief Title: Phase 1b DV281 With an Anti-PD-1 Inhibitor in NSCLC

Official Title: Phase 1b Dose Escalation and Dose Expansion Trial of DV281 in Combination With an Approved Anti-PD-1 Inhibitor in Subjects With Advanced Non-Small Cell Lung Cancer

Study ID: NCT03326752

Conditions

Advanced Non Small Cell Lung Cancer

Interventions

DV281

Breath Actuated Nebulizer

DV281 (RP2D)

Approved Anti-PD-1 Inhibitor

Study Description

Brief Summary: This open-label, multicenter, dose-escalation and expansion trial is designed to evaluate the safety and preliminary efficacy of inhaled DV281 in combination with nivolumabfor the treatment of NSCLC and to select a recommended phase 2 dose (RP2D).

Detailed Description: Pre-clinical studies support the proposed dosing schema to be tested and a potential benefit of the combination of inhaled DV281 with nivolumab for subjects with advanced NSCLC. This study (DV9-NSC-01) is designed for establishing an immunologically optimal RP2D for inhaled DV281 in combination with an approved anti-PD-1 inhibitor. This trial, studying the potential to enhance the efficacy of an approved anti-PD-1 inhibitor in subjects with advanced NSCLC, addresses an unmet need for NSCLC patients having tumors that do not respond or do not respond adequately to anti-PD-1 inhibitor monotherapy.