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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

  • Protocol Number: 202204044
  • Principal Investigator: Morgensztern, Daniel
  • Cancer Types: Lung

Learn more about this study at: clinicaltrials.gov

For more information on this trial, contact us here:

Phone
800-600-3606
Email
info@ccadmin.wustl.edu

Brief Summary

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.

The study will be conducted in 2 phases, a dose escalation and expansion phase (Phase 1) and a safety and efficacy evaluation phase (Phase 2). In Phase 1, patients will be enrolled in sequential cohorts treated with successively higher doses of Reqorsa in combination with pembrolizumab. When the recommended Phase 2 dose (RP2D) is determined, additional patients will be enrolled in an expansion cohort.

In Phase 2, patients will be randomized to receive Reqorsa with pembrolizumab or docetaxel +/- ramucirumab (active comparator).

Protocol Interventions

quaratusugene ozeplasmid, pembrolizumab, docetaxel, ramucirumab