Cancer Type: Thoracic
Study Type: Treatment
Phase: Phase I/II
Principal Investigator: Chiappori, Alberto
A Phase 1/2 Open-Label, Dose-Escalation and Clinical Response Study of Quaratusugene Ozeplasmid in Combination with Pembrolizumab versus Docetaxel with or without Ramucirumab in Patients with Previously Treated Non-Small Cell Lung Cancer (Acclaim 2)
The purpose of this randomized study is to determine the safety and efficacy of Reqorsa (quaratusugene ozeplasmid, formerly known as GPX-001), in combination with pembrolizumab in patients with previously treated NSCLC. Reqorsa consists of non-viral lipid nanoparticles that encapsulate a DNA plasmid with the TUSC2 tumor suppressor gene, and is the first systemic gene therapy.
Primary Objectives Phase 1: Identify maximum tolerated dose (MTD) of GPX-001 when given in combination with pembrolizumab and to evaluate the safety profile of this combination. Phase 2: Compare progression-free survival (PFS) of the GPX-001 plus pembrolizumab combination versus active comparator. Secondary Objectives Phase 2: Determine whether overall survival (OS) of GPX-001 in combination with pembrolizumab prolongs patient survival compared to active comparator. Evaluate the tolerability and toxicity of GPX-001 in combination with pembrolizumab.
Chemotherapy (NOS); Immunotherapy
GPX-001 (Quaratusugene Ozeplasmid); IMC-1121B (Ramucirumab); Pembrolizumab (Keytruda); Ramucirumab (); Taxotere (docetaxel); docetaxel ()
If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.
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