Non Small Cell Lung CancerPhase 1Acclaim-2NCT05062980
Quaratusugene Ozeplasmid (Reqorsa) in Combination With Pembrolizumab in Previously Treated Non-Small Lung Cancer
A Phase 1 study testing quaratusugene ozeplasmid, pembrolizumab and docetaxel in people with Non Small Cell Lung Cancer, run by Genprex, Inc. at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- quaratusugene ozeplasmid, pembrolizumab and docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 6 sitesUnited States
- Study dates
- 30 Mar 2022to 3 Feb 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Voluntarily signed an informed consent in accordance with institutional policies.
- 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.
- 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.
- For Phase 2, patients must have measurable disease per RECIST 1.1.
- 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.
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- ECOG performance status score from 0 to 1.
- 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.
- Demonstrate adequate organ function, as determined by the following laboratory values obtained within 21 days prior to enrollment:
- Absolute neutrophil count (ANC) ≥1,500/μL,
- Platelets ≥ 100,000/μL,
- Hemoglobin ≥8.0 g/dL ≥2 weeks without transfusions,
- International normalized ratio (INR) or prothrombin time (PT): ≤1.5 × upper limit of normal (ULN) unless the patient is receiving anticoagulant therapy as long as PT is within therapeutic range of intended use of anticoagulants,
- Activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT): ≤1.5 × ULN unless the patient is receiving anticoagulant therapy as long as aPTT is within therapeutic range of intended use of anticoagulants,
- Creatinine ≤1.5 × ULN OR calculated creatinine clearance (CrCl) ≥60 mL/min for patients with creatinine levels >1.5 × ULN,
- Serum total bilirubin ≤1.0 × ULN,
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤1.5 × ULN,
- Alkaline phosphatase ≤2.5 x ULN.
- Stable cardiac condition with a left ventricular ejection fraction >40% within ≤21 days prior to enrollment.
- Asymptomatic brain metastases, must meet ALL of the following criteria (a-d):
- No history of seizures in the preceding 6 months,
- Definitive treatment must be completed ≥4 weeks prior to enrollment,
- Stopped corticosteroid treatments administered because of brain metastases or related symptoms for ≥2 weeks prior to enrollment,
- Post-treatment imaging must demonstrate stability or regression of the brain metastases.
- Female patients of childbearing potential (FOCBP) must have a negative serum pregnancy test at screening (within 7 days of enrollment). Note: Non-childbearing potential is defined as greater than 1 year postmenopausal or surgically sterilized.
- FOCBP and non-sterile male patients with female partner(s) of childbearing potential must agree to use 2 forms of contraception including 1 highly effective and 1 effective method beginning ≥2 weeks prior to enrollment through 4 months following the last dose of study treatment.
- Male patients must agree to no sperm donation during study treatment and for an additional 4 months following the last dose of study treatment.
Who cannot join
- Unable to tolerate pembrolizumab treatment, leading to early treatment discontinuation or prolonged/frequent dosage modifications as determined by the investigator.
- Hypersensitivity to docetaxel or polysorbate 80 (Phase 2 only).
- Patients at risk of tumor lysis syndrome (e.g., renal impairment, hyperuricemia, bulky tumor [Phase 2 randomized portion only]).
- Received prior systemic chemotherapy or monoclonal antibodies for the treatment of the participant's advanced or metastatic disease within 21 days of study enrollment.
- Received prior gene therapy.
- 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.
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- Expected to require any other form of antineoplastic therapy while participating in the study.
- Received a live-virus vaccination within 1 month of enrollment. Seasonal flu vaccines that do not contain live virus are permitted.
- Has known active, symptomatic CNS metastases and/or carcinomatous meningitis.
- Active, known, or suspected autoimmune disease.
- Active systemic viral, bacterial, or fungal infections(s) requiring treatment.
- Serious concurrent illness or psychological, familial, sociological, geographical, or other condition that, in the opinion of the investigator, would prevent adequate follow-up and compliance with the study protocol.
- A condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study enrollment. Inhaled or topical steroids and adrenal replacement doses ≤10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
- Active concurrent malignancies, i.e., cancers other than NSCLC.
- Has a second, concurrent, untreated malignancy.
- History of symptomatic interstitial lung disease or pneumonitis that required oral (PO) or IV glucocorticoids to assist with management. Note: Lymphangitic spread of the NSCLC is not an exclusion criterion.
- History of myocardial infarction or unstable angina within 6 months prior to enrollment.
- Presence of pre-existing peripheral neuropathy that is ≥Grade 2 by NCI-CTCAE v5.0 criteria.
- Is, at the time of signing informed consent, a regular user (including "recreational use") of any illicit drugs or has a recent history (within the last year) of substance abuse (including alcohol) requiring medical intervention.
- Known human immunodeficiency virus (HIV) infection or has active hepatitis infection.
- Female patients who are pregnant or breastfeeding.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Mary Crowley Cancer Research
Dallas, Texas, 75230
Millennium Oncology
Houston, Texas, 77090
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
The Valley Hospital - Luckow Pavilion
Paramus, New Jersey, 07652
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, 63110
Moffitt Cancer Center - Magnolia Campus
Tampa, Florida, 33612
About this study
Official title: 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
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.
Due to slow enrollment, the Accliam-2 trial was closed in Phase 1 and Phase 2 was not conducted.
Read the 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.
Due to slow enrollment, the Accliam-2 trial was closed in Phase 1 and Phase 2 was not conducted.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- quaratusugene ozeplasmid, pembrolizumab, docetaxel, ramucirumab, Investigator's Treatment of Choice
- Keywords
- Tumor suppressor gene 2 (TUSC2), Lipid nanoparticle (LNP), pembrolizumab, Keytruda, Gene therapy, NSCLC, docetaxel, Reqorsa, Acclaim-2, quaratusugene ozeplasmid
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quaratusugene ozeplasmidBiological
Also called Reqorsa
Quaratusugene ozeplasmid is an experimental non-viral therapy utilizing the TUSC2 gene, designed to target cancer cells by interrupting cell signaling pathways that allow cancer cells to grow, re-establishing pathways that promote cancer cell death and modulating the immune system response against cancer cells.
pembrolizumabDrug
Also called Keytruda
Pembrolizumab is a programmed death receptor-1 (PD-1) blocking antibody indicated for treatment of patients with metastatic NSCLC.
docetaxelDrug
Also called Taxotere
Docetaxel is a microtubule inhibitor indicated for locally advanced or metastatic NSCLC after platinum-based chemotherapy failure.
ramucirumabDrug
Also called Cyramza
Ramucirumab is a human vascular endothelial growth factor receptor 2 (VEGFR2) antagonist indicated in combination with docetaxel for treatment of NSCLC with disease progression after platinum-based chemotherapy.
Investigator's Treatment of ChoiceDrug
Treatment will be administered during 21-day treatment cycles. The investigator's treatment must not include investigational drugs or therapies.
| Study group | Role | What they receive |
|---|---|---|
| Investigational | Experimental | In Phase 1, the dose expansion portion of Phase 2 and the investigational arm of the randomized portion of Phase 2, patients will receive their assigned dose of quaratusugene ozeplasmid (via intravenous infusion) in combination with a fixed 200 mg dose of pembrolizumab (via intravenous infusion) once in every 21-day treatment cycle until disease progression or unacceptable toxicity. Receives: Biological: quaratusugene ozeplasmid; Drug: pembrolizumab |
| Control | Active comparator | In the control arm of the randomized portion of Phase 2, patients will receive either 75 mg/m2 docetaxel (via intravenous infusion) with or without 10 mg/kg ramucirumab (via intravenous infusion) -OR- investigator's choice of treatment. The treatment regimen for patients randomized to the control arm, must begin at Cycle 1 Day 1 and continue every 21 days until disease progression or unacceptable toxicity. Receives: Drug: docetaxel; Drug: ramucirumab; Drug: Investigator's Treatment of Choice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended Phase 2 Dose (RP2D) - Phase 1
RP2D which will be the MTD or if the MTD is not defined by the safety data, the RP2D will be determined based on an integrated assessment of all available clinical safety, PK, and preliminary efficacy data.
Measured: First 21-days at each dose level
Progression-free Survival (PFS) - Phase 2 Dose Expansion
PFS rate at 18 weeks after first dose of study treatment. PFS according to RECIST.
Measured: 18 weeks
Progression-free Survival (PFS) - Phase 2 Randomized
PFS from randomization to disease progression or death. PFS according to RECIST.
Measured: Approximately 8 months
Secondary outcomes (13)
Progression-free Survival (PFS) - Phase 1
PFS from first study treatment to disease progression or death. PFS according to RECIST.
Measured: Approximately 8 months
Overall Survival (OS) - Phase 1
OS from first study treatment to death or discontinuation due to withdrawal of consent.
Measured: Approximately 11 months
Pharmacokinetics (PK) - Phase 1
Concentrations of quaratusugene ozeplasmid in whole blood samples.
Measured: First 21-day treatment cycle
Adverse Events (AEs) - Phase 2 Dose Expansion
Number of treatment-related AEs graded according to the NCI-CTCAE.
Measured: Approximately 9 months]
Progression-free Survival (PFS) - Phase 2 Dose Expansion
PFS from first study treatment to disease progression or death. PFS according to RECIST.
Measured: Approximately 8 months
Overall Response Rate (ORR) - Phase 2 Dose Expansion
ORR (Complete Response [CR] + Partial Response [PR]) using best overall response from first study treatment to disease progression or death per RECIST compared to baseline tumor measurements.
Measured: Approximately 8 months
Overall Survival (OS) - Phase 2 Dose Expansion
OS from first study treatment to death or discontinuation due to withdrawal of consent.
Measured: Approximately 11 months
Pharmacokinetics (PK) - Phase 2 Dose Expansion
Concentrations of quaratusugene ozeplasmid in whole blood samples.
Measured: First 21-day treatment cycle
Overall Response Rate (ORR) - Phase 2 Randomized
ORR (CR + PR) using best overall response from randomization to disease progression or death per RECIST compared to baseline tumor measurements.
Measured: Approximately 8 months
Overall Survival (OS) - Phase 2 Randomized
OS from randomization to death or discontinuation due to withdrawal of consent.
Measured: Approximately 11 months
Disease Control Rate (DCR) - Phase 2 Randomized
DCR (CR + PR + Stable Disease [SD]) using best overall response from randomization to death or discontinuation due to withdrawal of consent per RECIST compared to baseline tumor measurements.
Measured: Approximately 8 months
Adverse Events (AEs) - Phase 2 Randomized
Number of treatment-related AEs graded according to the NCI-CTCAE.
Measured: Approximately 9 months
Pharmacokinetics (PK) - Phase 2 Randomized
Concentrations of quaratusugene ozeplasmid in whole blood samples.
Measured: First 21-day treatment cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start30 Mar 2022
- Primary completion3 Feb 2025
- Study completion3 Feb 2025
Why it stopped: Enrollment was slow, due to competition with the many other clinical trials for the same patient population, which led to the decision to end enrollment in the trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Phase 1: 3+3 dose escalation to identify RP2D. (Trial closed in Phase 1 due to slow enrollment) Phase 2: RP2D expansion cohort followed by parallel randomization in a 2:1 ratio to either investigational arm or control arm. (Phase 2 not conducted due to trial closing in Phase 1)
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genprex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Morgensztern, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05062980
- Sponsor's protocol ID
- ONC-004
- Acronym
- Acclaim-2
- Status last verified
- May 2026
- First submitted
- 20 Sep 2021
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05062980
- Acronym / sponsor ID
- Acclaim-2 / ONC-004
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Tumor suppressor gene 2 (TUSC2), Lipid nanoparticle (LNP), pembrolizumab, Keytruda, Gene therapy, NSCLC, docetaxel, Reqorsa
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment was slow, due to competition with the many other clinical trials for the same patient population, which led to the decision to end enrollment in the trial.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Genprex, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- 3 Feb 2025 (actual)
- Study completion
- 3 Feb 2025 (actual)
- First posted
- 30 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Due to slow enrollment, the Accliam-2 trial was closed in Phase 1 and Phase 2 was not conducted.
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.
Due to slow enrollment, the Accliam-2 trial was closed in Phase 1 and Phase 2 was not conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase 1: 3+3 dose escalation to identify RP2D. (Trial closed in Phase 1 due to slow enrollment) Phase 2: RP2D expansion cohort followed by parallel randomization in a 2:1 ratio to either investigational arm or control arm. (Phase 2 not conducted due to trial closing in Phase 1)
| Arm | Type | Receives |
|---|---|---|
| Investigational | Experimental | Biological: quaratusugene ozeplasmid, Drug: pembrolizumabIn Phase 1, the dose expansion portion of Phase 2 and the investigational arm of the randomized portion of Phase 2, patients will receive their assigned dose of quaratusugene ozeplasmid (via intravenous infusion) in combination with a fixed 200 mg dose of pembrolizumab (via intravenous infusion) once in every 21-day treatment cycle until disease progression or unacceptable toxicity. |
| Control | Active comparator | Drug: docetaxel, Drug: ramucirumab, Drug: Investigator's Treatment of ChoiceIn the control arm of the randomized portion of Phase 2, patients will receive either 75 mg/m2 docetaxel (via intravenous infusion) with or without 10 mg/kg ramucirumab (via intravenous infusion) -OR- investigator's choice of treatment. The treatment regimen for patients randomized to the control arm, must begin at Cycle 1 Day 1 and continue every 21 days until disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Age ≥18 years.
- Voluntarily signed an informed consent in accordance with institutional policies.
- 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.
- 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.
- For Phase 2, patients must have measurable disease per RECIST 1.1.
Key exclusion criteria (21 listed)
- Unable to tolerate pembrolizumab treatment, leading to early treatment discontinuation or prolonged/frequent dosage modifications as determined by the investigator.
- Hypersensitivity to docetaxel or polysorbate 80 (Phase 2 only).
- Patients at risk of tumor lysis syndrome (e.g., renal impairment, hyperuricemia, bulky tumor [Phase 2 randomized portion only]).
- Received prior systemic chemotherapy or monoclonal antibodies for the treatment of the participant's advanced or metastatic disease within 21 days of study enrollment.
- Received prior gene therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| quaratusugene ozeplasmidAlso: ReqorsaQuaratusugene ozeplasmid is an experimental non-viral therapy utilizing the TUSC2 gene, designed to target cancer cells by interrupting cell signaling pathways that allow cancer cells to grow, re-establishing pathways that promote cancer cell death and modulating the immune system response against cancer cells. | Biological | Investigational |
| pembrolizumabAlso: KeytrudaPembrolizumab is a programmed death receptor-1 (PD-1) blocking antibody indicated for treatment of patients with metastatic NSCLC. | Drug | Investigational |
| docetaxelAlso: TaxotereDocetaxel is a microtubule inhibitor indicated for locally advanced or metastatic NSCLC after platinum-based chemotherapy failure. | Drug | Control |
| ramucirumabAlso: CyramzaRamucirumab is a human vascular endothelial growth factor receptor 2 (VEGFR2) antagonist indicated in combination with docetaxel for treatment of NSCLC with disease progression after platinum-based chemotherapy. | Drug | Control |
| Investigator's Treatment of ChoiceTreatment will be administered during 21-day treatment cycles. The investigator's treatment must not include investigational drugs or therapies. | Drug | Control |
Primary outcome
Recommended Phase 2 Dose (RP2D) - Phase 1
Time frame: First 21-days at each dose level
RP2D which will be the MTD or if the MTD is not defined by the safety data, the RP2D will be determined based on an integrated assessment of all available clinical safety, PK, and preliminary efficacy data.
Progression-free Survival (PFS) - Phase 2 Dose Expansion
Time frame: 18 weeks
PFS rate at 18 weeks after first dose of study treatment. PFS according to RECIST.
Progression-free Survival (PFS) - Phase 2 Randomized
Time frame: Approximately 8 months
PFS from randomization to disease progression or death. PFS according to RECIST.
13 secondary outcomes
Progression-free Survival (PFS) - Phase 1
Time frame: Approximately 8 months
Overall Survival (OS) - Phase 1
Time frame: Approximately 11 months
Pharmacokinetics (PK) - Phase 1
Time frame: First 21-day treatment cycle
Adverse Events (AEs) - Phase 2 Dose Expansion
Time frame: Approximately 9 months]
Progression-free Survival (PFS) - Phase 2 Dose Expansion
Time frame: Approximately 8 months
Overall Response Rate (ORR) - Phase 2 Dose Expansion
Time frame: Approximately 8 months
Overall Survival (OS) - Phase 2 Dose Expansion
Time frame: Approximately 11 months
Pharmacokinetics (PK) - Phase 2 Dose Expansion
Time frame: First 21-day treatment cycle
Overall Response Rate (ORR) - Phase 2 Randomized
Time frame: Approximately 8 months
Overall Survival (OS) - Phase 2 Randomized
Time frame: Approximately 11 months
Disease Control Rate (DCR) - Phase 2 Randomized
Time frame: Approximately 8 months
Adverse Events (AEs) - Phase 2 Randomized
Time frame: Approximately 9 months
Pharmacokinetics (PK) - Phase 2 Randomized
Time frame: First 21-day treatment cycle
Results and safety
The study was stopped early (reason given: Enrollment was slow, due to competition with the many other clinical trials for the same patient population, which led to the decision to end enrollment in the trial.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
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Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Morgensztern, MD principal investigator
Washington University School of Medicine
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing quaratusugene ozeplasmid, pembrolizumab and docetaxel in people with Non Small Cell Lung Cancer, run by Genprex, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Enrollment was slow, due to competition with the many other clinical trials for the same patient population, which led to the decision to end enrollment in the trial.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recommended Phase 2 Dose (RP2D) - Phase 1 (time frame: First 21-days at each dose level). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.