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 the safety and effectiveness of a new gene therapy treatment, Reqorsa (quaratusugene ozeplasmid), combined with pembrolizumab, for individuals with non-small cell lung cancer (NSCLC) that has progressed after prior treatment. The study will first determine the optimal dose and then compare this combination to standard treatments. Ideal candidates for this trial are those with NSCLC who previously benefitted from pembrolizumab but have experienced cancer progression. As a Phase 1/Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, you cannot have received certain treatments like systemic chemotherapy or monoclonal antibodies within 21 days before enrolling, and you should not expect to need other cancer treatments during the study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that combining Reqorsa with pembrolizumab has been safe in earlier studies. In a previous study with a similar combination, patients did not experience severe side effects that required stopping the treatment, indicating no dose-limiting toxicities. So far, the combination has been well-tolerated, with no major safety concerns reported.
These findings are promising, but current clinical trials are still assessing safety. The treatment uses Reqorsa, a gene therapy that delivers a tumor-fighting gene, along with pembrolizumab, an immunotherapy drug. While the FDA has approved pembrolizumab for other uses, its combination with Reqorsa remains under study. Overall, early results suggest the combination is generally safe for patients, but ongoing trials will provide more detailed safety information.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Reqorsa (quaratusugene ozeplasmid) in combination with pembrolizumab for lung cancer because it offers a novel approach compared to standard treatments like chemotherapy and immunotherapy. Unlike traditional therapies, Reqorsa is a gene therapy that aims to enhance the immune response against cancer cells by delivering a gene directly into the cells. This can potentially boost the effectiveness of pembrolizumab, an existing immunotherapy that helps the immune system recognize and attack cancer cells. The unique combination of a gene therapy with an immune checkpoint inhibitor could provide a more effective treatment option for patients with lung cancer.
What evidence suggests that this trial's treatments could be effective for lung cancer?
This trial will compare the investigational combination of Reqorsa (quaratusugene ozeplasmid) and pembrolizumab with a control arm. Studies have shown promising results for using Reqorsa and pembrolizumab together to treat non-small cell lung cancer (NSCLC). Research indicates that this combination can help patients live longer without their cancer worsening. Initial findings suggest that Reqorsa uses a gene to fight cancer, boosting the body's immune response, including natural killer cells that attack cancer cells. Pembrolizumab is a well-known treatment that helps the immune system find and attack cancer. Together, they aim to provide a stronger defense against the disease.23678
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:
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
- Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
Find a Clinic Near You
Who Is Running the Clinical Trial?
Genprex, Inc.
Lead Sponsor