Quaratusugene Ozeplasmid + Atezolizumab for Small Cell Lung Cancer
(Acclaim-3 Trial)
Recruiting in Palo Alto (17 mi)
+11 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: Genprex, Inc.
Must be taking: Atezolizumab
Disqualifiers: Autoimmune disease, HIV, Hepatitis, others
No Placebo Group
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?This clinical trial will evaluate the combination of quaratusugene ozeplasmid with atezolizumab as maintenance therapy for patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC).
The study is comprised of 2 phases, a dose selection phase (Phase 1) and a safety and efficacy evaluation phase (Phase 2).
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
What data supports the effectiveness of the drug combination Quaratusugene Ozeplasmid + Atezolizumab for Small Cell Lung Cancer?
Atezolizumab, when combined with chemotherapy, has been shown to improve survival outcomes in patients with extensive-stage small cell lung cancer, as demonstrated in the IMpower133 trial. This combination was generally well tolerated and did not negatively impact patients' quality of life.
12345What is known about the safety of Atezolizumab and Quaratusugene Ozeplasmid in humans?
Atezolizumab has been shown to have manageable safety in various studies for different types of cancer, including lung and bladder cancer. It has been evaluated in combination with other treatments and has been found to improve survival with a manageable safety profile in patients with small cell lung cancer.
678910What makes the drug Quaratusugene Ozeplasmid + Atezolizumab unique for small cell lung cancer?
Quaratusugene Ozeplasmid (Reqorsa) combined with Atezolizumab is unique because it combines a novel gene therapy approach with an immune checkpoint inhibitor, potentially offering a new mechanism to enhance the immune system's ability to fight small cell lung cancer, which is different from traditional chemotherapy or single-agent immunotherapy.
111121314Eligibility Criteria
This trial is for adults with Extensive Stage Small Cell Lung Cancer who've had a stable heart condition, responded well to initial cancer therapy without severe side effects, and have good physical functioning. They should not have recent major surgeries or active complications from past surgeries. Brain metastases must be treated and stable. Blood counts and organ functions need to be within certain limits.Inclusion Criteria
My kidney function is good, with creatinine levels at or below 1.5 mg/dL.
My small cell lung cancer was confirmed by lab tests before starting treatment with atezolizumab, carboplatin, and etoposide.
I agree not to donate sperm during and for 4 months after the study.
+19 more
Exclusion Criteria
I have not had a heart attack or unstable chest pain in the last 6 months.
I have undergone gene therapy before.
I am currently being treated for a serious infection.
+6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Dose Selection (Phase 1)
Participants receive quaratusugene ozeplasmid and atezolizumab to determine the recommended Phase 2 dose (RP2D)
21 days per dose level
IV administration once every 21 days
Safety and Efficacy Evaluation (Phase 2)
Participants are treated with the RP2D of quaratusugene ozeplasmid and atezolizumab until disease progression or unacceptable toxicity
18 weeks
IV administration once every 21 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
Approximately 5 months
Participant Groups
The trial is testing quaratusugene ozeplasmid (Reqorsa) combined with atezolizumab as a maintenance treatment after initial success with chemotherapy in ES-SCLC patients. It's done in two parts: first to find the right dose and second to check how safe and effective it is.
2Treatment groups
Experimental Treatment
Group I: Phase 2Experimental Treatment2 Interventions
Patients will be treated with the RP2D of quaratusugene ozeplasmid (IV administration once every 21 days) plus atezolizumab (1200 mg IV administration once every 21 days) or atezolizumab and hyaluronidase-tqjs (15 mL subcutaneous \[SQ\] administration once every 21 days) until disease progression or unacceptable toxicity
Group II: Phase 1Experimental Treatment2 Interventions
Up to 2 sequential dose selection cohorts will be treated with quaratusugene ozeplasmid (intravenous (IV) administration once every 21 days) plus atezolizumab (1200 mg IV administration once every 21 days) until disease progression or unacceptable toxicity.
Quaratusugene ozeplasmid doses will be evaluated (0.09 \[starting dose\], and 0.12 mg/kg) until the RP2D is identified.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Willamette Valley Cancer Institute (Oregon)Eugene, OR
Oncology_Hematology Care Clinical Trials, LLCCincinnati, OH
Northwest Cancer Specialists, P.C.Portland, OR
Providence Cancer InstitutePortland, OR
More Trial Locations
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Who Is Running the Clinical Trial?
Genprex, Inc.Lead Sponsor
References
A 75-Year-Old Female Smoker with Advanced Small-Cell Lung Cancer and Eastern Cooperative Oncology Group Performance Status 2 who Responded to Combination Immunochemotherapy with Atezolizumab, Etoposide, and Carboplatin. [2022]BACKGROUND Atezolizumab is an immune checkpoint inhibitor used as first-line treatment with carboplatin and etoposide chemotherapy for advanced small cell lung cancer. Immunochemotherapy treatment decisions can be affected by patients' physical ability. Because of the exclusion of patients with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≥2 from clinical trials, treatment outcome evidence in this group is limited. CASE REPORT We present the case of a 75-year-old woman with an ECOG PS of 2 admitted with respiratory symptoms and diagnosed with advanced small-cell lung cancer. After managing exacerbation of COPD and decompensated heart failure, atezolizumab with carboplatin and etoposide was administered. After 2 cycles of immunochemotherapy, deterioration of health was observed, including anemia and thrombocytopenia. Because of the good response in imaging tests and restored balance of the patient condition, immunochemotherapy was continued. After 4 cycles of combined treatment, complete regression was achieved. No another adverse effects were observed. The patient was qualified for maintenance therapy with atezolizumab. In follow-up CT scan after 2 cycles of atezolizumab, progression was observed and patient was qualified for second-line treatment. CONCLUSIONS This report presents the case of an older patient with advanced small cell lung cancer and an ECOG status of 2 who responded to combined immunochemotherapy with atezolizumab, etoposide, and carboplatin. Adverse effects observed during immunotherapy were not a reason for discontinuation of the therapy. The assessment of the effectiveness of immunotherapy in patients with ECOG PS ³2 is difficult owing to the insufficient representation of this group in clinical trials.
Atezolizumab addition to platinum doublet: evaluating survival outcomes for patients with extensive disease small cell lung cancer. [2023]The efficacy of adding atezolizumab to the platinum doublet regimen for extensive disease small cell lung cancer (ED-SCLC) remains marginally limited.
Atezolizumab: A Review in Extensive-Stage SCLC. [2021]Atezolizumab (Tecentriq®), a fully humanized, monoclonal anti-programmed cell death ligand-1 (PD-L1) antibody, is the first immune checkpoint inhibitor to be approved, in combination with carboplatin and etoposide, for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). Approval was based on primary data from the multinational phase I/III IMpower133 trial in PD-L1-unselected patients with previously untreated ES-SCLC. In this trial, induction therapy with atezolizumab plus carboplatin and etoposide followed by maintenance therapy with atezolizumab alone significantly prolonged overall survival (OS) and progression-free survival (PFS) compared with carboplatin and etoposide alone. The addition of atezolizumab to chemotherapy was generally well tolerated, with no new safety signals being identified beyond those previously reported for the individual agents. The most common grade 3-4 treatment-related adverse events with this regimen were haematological; the most common immune-related adverse events included rash and hypothyroidism. Importantly, the addition of atezolizumab to chemotherapy improved survival outcomes without adversely impacting patient-reported health-related quality of life (HRQOL). Thus, atezolizumab in combination with carboplatin plus etoposide has emerged as a valuable option for the first-line treatment of ES-SCLC and is being accepted as a standard of care in this setting.
A potential treatment option for transformed small-cell lung cancer on PD-L1 inhibitor-based combination therapy improved survival. [2023]Transformed small-cell lung cancer (T-SCLC) has an extremely poor prognosis, and no remedies based on immunotherapy have been evaluated among T-SCLC patients. We retrospectively analysed the efficacy and safety of combining atezolizumab with chemotherapy for T-SCLC.
First-line atezolizumab plus chemotherapy in treatment of extensive small cell lung cancer: a cost-effectiveness analysis from China. [2023]IMpower 133 trial first confirmed the efficacy and safety of adding atezolizumab or placebo to first-line treatment with chemotherapy in patients with extensive-stage small-cell lung cancer (SCLC). While, overprice limited its broad use in clinical. The aim of this study was to evaluate the cost-effectiveness of atezolizumab plus chemotherapy in treatment of extensive SCLC as first line in China.
Primary results from TAIL: a global single-arm safety study of atezolizumab monotherapy in a diverse population of patients with previously treated advanced non-small cell lung cancer. [2021]Atezolizumab treatment improves survival, with manageable safety, in patients with previously treated advanced/metastatic non-small cell lung cancer. The global phase III/IV study TAIL (NCT03285763) was conducted to evaluate the safety and efficacy of atezolizumab monotherapy in a clinically diverse population of patients with previously treated non-small cell lung cancer, including those not eligible for pivotal trials.
Atezolizumab in Patients with Metastatic Urothelial Carcinoma Who Have Progressed After First-line Chemotherapy: Results of Real-life Experiences. [2022]Atezolizumab (ATZ) has demonstrated antitumor activity and manageable safety in previous studies in patients with locally advanced or metastatic platinum-resistant urothelial carcinoma.
Population pharmacokinetics, exposure-safety, and immunogenicity of atezolizumab in pediatric and young adult patients with cancer. [2023]The iMATRIX-atezolizumab study was a phase I/II, multicenter, open-label study designed to assess the safety and pharmacokinetics of atezolizumab in pediatric and young adult patients. We describe the pharmacokinetics (PK), exposure-safety, and immunogenicity of atezolizumab in pediatric and young adults with metastatic solid tumors or hematologic malignancies enrolled in this study.
Safety and patient-reported outcomes of atezolizumab, carboplatin, and etoposide in extensive-stage small-cell lung cancer (IMpower133): a randomized phase I/III trial. [2022]The addition of atezolizumab to carboplatin and etoposide (CP/ET) significantly improved progression-free and overall survival for patients with extensive-stage small-cell lung cancer (ES-SCLC) in the IMpower133 study (NCT02763579). We have evaluated adverse events (AEs) and patient-reported outcomes in IMpower133 to assess the benefit-risk profile of this regimen.
Atezolizumab combined with chemotherapy in the first-line treatment of extensive-stage small cell lung cancer: a real-life data of the Turkish Oncology Group. [2022]Atezolizumab has been shown to be effective and safe in randomized trial in the first-line treatment of extensive-stage small cell lung cancer (SCLC). However, there are limited real-life data on atezolizumab. In this study, we aimed to determine the real-life efficacy and safety of atezolizumab combined with chemotherapy in the first-line treatment of extensive-stage SCLC.
Efficacy of Atezolizumab for Advanced Non-Small Cell Lung Cancer Based on Clinical and Molecular Features: A Meta-Analysis. [2022]Atezolizumab is becoming a significant therapy for non-small cell lung cancer (NSCLC), but its efficacy needs to be further improved. The aims of this study are to clarify the potency of atezolizumab-based therapy in advanced NSCLC patients with different clinical and molecular features, and to choose a better therapeutic regimen of atezolizumab to achieve more precise treatment in immunotherapy.
Efficacy of neoadjuvant atezolizumab treatment in patients with advanced urothelial bladder cancer according to the BASQ classification: a study protocol for an open-label, two-cohort, phase II trial. [2021]Atezolizumab is a programmed death ligand-1 inhibitor for urothelial bladder cancer treatment. Atezolizumab has become the standard therapy for patients with urothelial bladder cancer who are not responding to cisplatin-based chemotherapy and is also used as a first-line treatment in cisplatin-ineligible patients. However, the efficacy of atezolizumab as a neoadjuvant chemotherapy for radical cystectomy has not yet been published and is still under study. This trial investigates the effectiveness of basal/squamous-like (BASQ) classification in the selection of an effective target group of patients with muscle-invasive bladder cancer (MIBC) for neoadjuvant atezolizumab treatment.
Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial. [2022]Atezolizumab is a humanised antiprogrammed death-ligand 1 (PD-L1) monoclonal antibody that inhibits PD-L1 and programmed death-1 (PD-1) and PD-L1 and B7-1 interactions, reinvigorating anticancer immunity. We assessed its efficacy and safety versus docetaxel in previously treated patients with non-small-cell lung cancer.
Anti PD-L1 antibody: is there a histologic-oriented efficacy? Focus on atezolizumab in squamous cell non-small cell lung cancer. [2022]Squamous cell lung cancer (SqCLC) is the second most common histotype of non-small cell lung cancer (NSCLC) and is characterized by severe prognosis and lack of specific target agents. Atezolizumab is the first anti Programmed Death Ligand-1 (PDL-1) inhibitor approved for NSCLC patients of both histology in case of disease progression after first or further lines of therapy. Numerous studies are investigating the potential role of atezolizumab in different therapeutic setting, including SqCLC subtype. We searched for published clinical trials in Pubmed database, using the terms "atezolizumab", "squamous cell lung cancer", "NSCLC" and "non-small cell lung cancer". We also searched for recently concluded and not yet published or ongoing trials in clinicaltrials.gov and in data from the latest international congresses. The aim of this review is to summarize current evidence on atezolizumab in SqCLC, from first line setting to novel potential indications from ongoing trials. Strengths and weaknesses of atezolizumab treatment were highlighted to speculate the role of this immune checkpoint inhibitor in novel future clinical scenarios.