Study on Quaratusugene Ozeplasmid and Atezolizumab Maintenance Therapy for Extensive Stage Small Cell Lung Cancer
Sponsor: Genprex, Inc.
ClinicalTrials ID:NCT05703971
This clinical trial is testing a new combination of treatments, quaratusugene ozeplasmid and atezolizumab, to see if they can help maintain control of extensive stage small cell lung cancer (ES-SCLC) after initial chemotherapy and immunotherapy.
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Program Overview
The study aims to find out if combining quaratusugene ozeplasmid with atezolizumab can effectively maintain cancer control in patients with extensive stage small cell lung cancer (ES-SCLC) who have already responded to initial treatment. The trial will be conducted in two phases: Phase 1 will determine the best dose of quaratusugene ozeplasmid to use with atezolizumab, and Phase 2 will evaluate the safety and effectiveness of this combination at the selected dose.
Description
This study, called Acclaim-3, is an open-label trial conducted at multiple centers. It is designed to evaluate the combination of quaratusugene ozeplasmid with atezolizumab as a maintenance therapy for patients with extensive stage small cell lung cancer (ES-SCLC). Participants in the study must have already received 3 to 4 cycles of initial treatment with carboplatin, etoposide, and atezolizumab, and their cancer must not have progressed during this time.
In Phase 1, different groups of patients will receive increasing doses of quaratusugene ozeplasmid along with atezolizumab to find the best dose for Phase 2. The safety of the treatment will be closely monitored, and any serious side effects will be reviewed by a safety committee.
In Phase 2, the selected dose from Phase 1 will be used to further evaluate the safety and effectiveness of the treatment combination. The study will assess how well the treatment works in maintaining cancer control and any side effects experienced by the participants.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of extensive stage small cell lung cancer (ES-SCLC) before starting treatment with atezolizumab, carboplatin, and etoposide.
- Show a complete response, partial response, or stable disease after receiving 3 to 4 cycles of the initial treatment.
- Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Be at least 28 days past major surgeries and 10 days past minor surgeries, with no major complications.
- Have stable, asymptomatic brain metastases that meet specific criteria, including no recent seizures and no need for steroids.
- Have adequate blood cell counts, kidney function, liver function, and heart function as determined by specific tests.
- Women of childbearing potential must have a negative pregnancy test and agree to use two forms of contraception during the study and for 4 months after.
- Men must agree not to donate sperm during the study and for 4 months after.
- Must provide informed consent to participate in the study.
Exclusion Criteria
- Unable to tolerate atezolizumab treatment in the past, leading to early discontinuation or frequent dose changes.
- Have received prior gene therapy.
- Have received preventive brain radiation or additional chest radiation.
- Have active infections requiring treatment.
- Have serious health conditions or other issues that would prevent proper follow-up and compliance with the study.
- Have a history of autoimmune disease requiring immunosuppression.
- Have had a heart attack or unstable chest pain within the last 6 months.
- Have known HIV infection or active hepatitis.
- Are pregnant or breastfeeding.
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