Reqorsa + Pembrolizumab for Lung Cancer
(Acclaim-2 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new gene therapy (Reqorsa) combined with an existing cancer drug (pembrolizumab) in lung cancer patients who have previously benefited from pembrolizumab. The gene therapy delivers a tumor-suppressing gene, while pembrolizumab helps the immune system fight cancer.
Who Is on the Research Team?
Daniel Morgensztern
Principal Investigator
Washington University School of Medicine
Are You a Good Fit for This Trial?
Adults over 18 with previously treated non-small cell lung cancer (NSCLC) who have had some benefit from prior treatments like pembrolizumab or chemotherapy, but whose disease has progressed. They must not be pregnant, agree to use contraception, and should not have serious health issues that could interfere with the trial.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation (Phase 1)
Patients are enrolled in sequential cohorts treated with successively higher doses of quaratusugene ozeplasmid in combination with pembrolizumab to determine the recommended Phase 2 dose (RP2D).
Dose Expansion (Phase 2)
Patients receive quaratusugene ozeplasmid at the RP2D in combination with pembrolizumab to better characterize safety and preliminary efficacy.
Randomized Treatment (Phase 2)
Patients are randomized to receive either the investigational treatment of quaratusugene ozeplasmid in combination with pembrolizumab or a control treatment of docetaxel +/- ramucirumab or the investigator's treatment of choice.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Docetaxel
- Pembrolizumab
- Ramucirumab Injection [Cyramza]
- Reqorsa (quaratusugene ozeplasmid)
Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Genprex, Inc.
Lead Sponsor