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

Reqorsa is a DNA-lipid complex containing the TUSC2 gene

In this study, the sponsor and investigators want to learn:

• How much of the study agent in combination with pembrolizumab can be given with an acceptable level of side effects
• The effects of the study agent and pembrolizumab (good and bad)
• How much of the study agent is absorbed into the blood and how fast it is removed
• The effects of the study agent and pembrolizumab when compared to cancer treatments that are approved for your cancer

Phase 1 is a dose escalation study. Dose Escalation means that the amount of the study agent will be increased in each group of research participants, to find the most appropriate dose for further study.

The first part of Phase 2 is the dose expansion part of the study, in which a larger number of people receive the study agent at the dose determined to be appropriate in the dose escalation part of the study.

All participants in the first part of this study (Phase 1) will receive the study agent in combination with pembrolizumab. The combination of the study agent and pembrolizumab is also considered investigational. The Phase 2 portion of the study will be further divided into two parts. The first part of Phase 2 will be similar to Phase 1, with more participants receiving the study agent in combination with pembrolizumab. The second part of Phase 2, also called the “Randomization” part, will include some participants receiving the same combination of the study agent and pembrolizumab, and some participants being part of the “control arm”. Randomization means that you will be put in either of the groups by chance, like pulling straws from a hat. Two-thirds of the study participants will receive the combination of quaratusugene ozeplasmid plus pembrolizumab, and one-third will be randomized to the control arm. Participants in the “control arm” will receive other cancer drugs approved for your cancer, that may include either docetaxel alone or combined with ramucirumab, or another drug as determined by the study doctor.

It is not known whether the study regimen is better, the same as, or worse than the usual treatment (called “standard of care” therapy) given to people with this disease who are not taking part in a research study. For this reason, some research participants will receive the study regimen and some will receive the standard of care therapy. This will allow study doctors to compare the benefits and side effects of the two regimens.

The part of the study and dose of the study agent you receive will be determined by when you join the study.

The study regimen will be given in cycles.  Each cycle is 21 days. The study agent is given on Day 1 of every cycle as an IV infusion into a vein over about 30 minutes. Pembrolizumab is also given as an IV infusion into a vein over about 30 minutes. In the first cycle, pembrolizumab will be given on Day 2. In all other cycles, pembrolizumab will be given on Day 1 after the study agent.

If you are in the control arm of the randomized portion of this study, you will receive the standard of care cancer treatment determined by the study doctor once a cycle.