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Quaratusugene Ozeplasmid (Reqorsa) in Combination With Pembrolizumab in Previously Treated Non-Small Lung Cancer | Clinical Trials | Clareo Health

TERMINATEDPHASE1/PHASE2

Quaratusugene Ozeplasmid (Reqorsa) in Combination With Pembrolizumab in Previously Treated Non-Small Lung Cancer

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

NCT05062980•Genprex, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine the safety and efficacy of quaratusugene ozeplasmid (Reqorsa), in combination with pembrolizumab in patients with previously treated NSCLC. Quaratusugene ozeplasmid consists of non-viral lipid nanoparticles that encapsulate a DNA plasmid with the TUSC2 tumor suppressor gene, and is a systemic gene therapy. The study will be conducted in 2 phases, a dose escalation phase (Phase 1) and a safety and efficacy evaluation phase (Phase 2). In Phase 1, patients will be enrolled in sequential cohorts treated with successively higher doses of quaratusugene ozeplasmid in combination with pembrolizumab to determine the recommended Phase 2 dose (RP2D). Phase 2 will be comprised of a dose expansion portion and a randomized portion. In the dose expansion portion, patients will be enrolled and treated with quaratusugene ozeplasmid at the RP2D in combination with pembrolizumab. In the randomized portion, patients will be randomized to receive either the investigational treatment of quaratusugene ozeplasmid at the RP2D in combination with pembrolizumab or a control treatment of either docetaxel +/- ramucirumab or the investigator's treatment of choice.

Detailed Description

Acclaim-2 is a Phase 1/2 multicenter, open-label study of quaratusugene ozeplasmid in combination with pembrolizumab in patients with locally advanced or metastatic NSCLC with any PD-L1 TPS and NOT considered refractory to pembrolizumab, as defined by having achieved at least a 3-month clinical benefit to previous pembrolizumab-containing treatment. The total duration of study for each patient will be dependent upon the safety, tolerability, and efficacy of the study treatment. The Phase 1 portion of the study will involve a 3+3 dose escalation schema of quaratusugene ozeplasmid up to 0.12 mg/kg in combination with a fixed dose of pembrolizumab (200 mg) administered once via intravenous (IV) infusion during each 21-day treatment cycle. Three quaratusugene ozeplasmid doses will be tested (0.06, 0.09 and 0.12 mg/kg administered on Day 1 of a 21-day treatment cycle). Phase 2 will involve a dose expansion portion and a randomized portion. In the dose expansion portion 36 patients will be enrolled to better characterize the safety and preliminary efficacy of quaratusugene in combination with pembrolizumab. Patients in the dose expansion portion will receive quaratusugene ozeplasmid at the RP2D determined in Phase 1 in combination with pembrolizumab once in every 21-day treatment cycle. When the PFS rate at 18 weeks has been evaluated for all patients in the dose expansion portion and been shown to meet the criteria for advancement to the randomized portion of Phase 2, the randomized portion of Phase 2 will be initiated. In the randomized portion of Phase 2, 126 patients will be randomized 2:1 to the investigational (quaratusugene ozeplasmid in combination with pembrolizumab) versus control (docetaxel with or without ramucirumab, or investigator's choice of treatment) treatment arms, respectively. Patients will be stratified by NSCLC histology (squamous versus nonsquamous predominant histology) for efficacy analysis purposes. The 84 patients randomized to the investigational arm will receive quaratusugene ozeplasmid, at the RP2D determined in Phase 1, administered in combination with 200 mg pembrolizumab once in every 21-day treatment cycle. The 42 patients randomized to the control arm may either receive docetaxel with or without ramucirumab, or a non-investigational treatment chosen by the investigator.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients will have their most recent archival tumor biopsy submitted to a central laboratory for IHC analysis.
•1. Age ≥18 years.
•2. Voluntarily signed an informed consent in accordance with institutional policies.
•3. Histologically or cytologically documented NSCLC (SQ, NSQ, or mixed (adenosquamous) histology) with locally advanced or metastatic disease. Note: Any level of PD-L1 TPS is allowed.
•4. Achieved clinical benefit to prior pembrolizumab or pembrolizumab/platinum-based chemotherapy for at least 3 months and subsequently progressed as confirmed by radiological tumor assessment per RECIST 1.1. Patients receiving pembrolizumab as a single agent must have additional therapy with a platinum-based chemotherapy prior to enrolling, but patients receiving pembrolizumab in combination with a platinum-based chemotherapy should have enrollment in this trial as the next treatment regimen. Chemotherapy is to be limited such that study treatment will be 2nd or 3rd line.
•5. For Phase 2, patients must have measurable disease per RECIST 1.1.
•6. Patients with genetic alterations with FDA-approved therapy (such as EGFR or anaplastic lymphoma kinase \[ALK\] mutations) must have disease progression after treatment with appropriate targeted therapy and must be eligible for immunotherapy as determined by the investigator.
•7. ECOG performance status score from 0 to 1.
•8. Must be ≥28 days beyond major surgical procedures such as thoracotomy, laparotomy, or joint replacement, and must be ≥10 days beyond minor surgical procedures such as biopsy of subcutaneous tumors, pleuroscopy, etc., and must not have evidence of wound dehiscence, active wound infection, or comparable major residual complications of the surgery. Note: Placement of pleural catheter despite being a minor surgical procedure, may be performed \<10 days prior to study enrollment.
•9. Demonstrate adequate organ function, as determined by the following laboratory values obtained within 21 days prior to enrollment:
+18 more criteria

Exclusion Criteria

•1. Unable to tolerate pembrolizumab treatment, leading to early treatment discontinuation or prolonged/frequent dosage modifications as determined by the investigator.
•2. Hypersensitivity to docetaxel or polysorbate 80 (Phase 2 only).
•3. Patients at risk of tumor lysis syndrome (e.g., renal impairment, hyperuricemia, bulky tumor \[Phase 2 randomized portion only\]).
•4. Received prior systemic chemotherapy or monoclonal antibodies for the treatment of the participant's advanced or metastatic disease within 21 days of study enrollment.
•5. Received prior gene therapy.
•6. Received any radiotherapy to the skull, spine, thorax, or pelvis within 1 month of study enrollment. Note: Patients are permitted to have received palliative radiotherapy to an extremity provided at least 14 days has elapsed since completion of therapy, provided the patient received no more than 10 radiotherapy fractions and a dose no higher than 30 Gy to that site.
•7. Expected to require any other form of antineoplastic therapy while participating in the study.
•8. Received a live-virus vaccination within 1 month of enrollment. Seasonal flu vaccines that do not contain live virus are permitted.
•9. Has known active, symptomatic CNS metastases and/or carcinomatous meningitis.
•10. Active, known, or suspected autoimmune disease.
+11 more criteria

Locations (6)

Moffitt Cancer Center - Magnolia Campus

Tampa, Florida, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Washington University School of Medicine - Siteman Cancer Center

St Louis, Missouri, United States

The Valley Hospital - Luckow Pavilion

Paramus, New Jersey, United States

Mary Crowley Cancer Research

Dallas, Texas, United States

Millennium Oncology

Houston, Texas, United States

Key Dates

Start Date

March 30, 2022

Primary Completion Date

February 3, 2025

Completion Date

February 3, 2025

Last Updated

February 20, 2025

Enrollment

ACTUAL participants

Conditions

Non Small Cell Lung Cancer

Interventions

quaratusugene ozeplasmid

BIOLOGICAL

pembrolizumab

DRUG

docetaxel

DRUG

ramucirumab

DRUG

Investigator's Treatment of Choice

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Quaratusugene Ozeplasmid (Reqorsa) in Combination With Pembrolizumab in Previously Treated Non-Small Lung Cancer

Inclusion Criteria

Exclusion Criteria

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers

A Study to Evaluate the Benefit of Adding Durvalumab After Chemotherapy, Durvalumab and Surgery in Patients With Early-stage, Operable, Non-small Cell Lung Cancer.

Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)

A Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) to Keytruda® in Non-small Cell Lung Cancer (BENITO Study)