Carcinoma, Non-Small Cell LungPhase 1/2Acclaim-1NCT04486833
Quaratusugene Ozeplasmid (Reqorsa) and Osimertinib in Patients With Advanced Lung Cancer Who Progressed on Osimertinib
A Phase 1/2 study testing quaratusugene ozeplasmid, osimertinib and Platinum-Based Chemotherapy in people with Carcinoma, Non-Small Cell Lung, run by Genprex, Inc. at 10 sites in United States.
Trial summary
The purpose of this randomized study is to determine the safety and efficacy of quaratusugene ozeplasmid (Reqorsa) added to osimertinib in NSCLC patients with activating EGFR mutations who have progressed while on treatment with osimertinib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small Cell Lung
- What is being tested?
- quaratusugene ozeplasmid, osimertinib and Platinum-Based Chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 10 sitesUnited States
- Study dates
- 3 Sep 2021to Mar 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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.
- Histologically or cytologically documented NSCLC.
- Stage III or IV NSCLC or recurrent NSCLC that is not potentially curable by radiotherapy or surgery.
- The NSCLC must be epidermal growth factor receptor (EGFR) mutation positive-positive based on results from most recent tissue biopsy or most recent evaluation of circulating tumor DNA.
- Achieved clinical response to osimertinib for ≥4 months, which can be a response of stable disease. Must have a minimum of a 10-day osimertinib washout completed at the time of enrollment.
- Must have radiological progression on osimertinib treatment and can have either asymptomatic disease or symptomatic disease. In addition:
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- Must have measurable disease per RECIST 1.1.
- Must have progression on osimertinib treatment as a single agent or in combination with other anti-cancer agents as their most recent treatment.
- Notes:
- Patients may have had treatment with other EGFR inhibitors as single agents prior to osimertinib.
- Patients may have progression on osimertinib treatment being used for adjuvant therapy after surgery.
- Eastern Cooperative Oncology Group performance status (ECOG PS) score from 0 to 1.
- Must be ≥28 days beyond major surgical procedures such as thoracotomy, laparotomy, or joint replacement and must not have evidence of wound dehiscence, active wound infection, or comparable major residual complications of the surgery per Investigator assessment.
- Asymptomatic brain metastases must meet ALL criteria of the following (a-d):
- No history of seizures in the preceding six months.
- Definitive treatment must be completed ≥21 days.
- Must be off steroids administered because of brain metastases or related symptoms for ≥7 days.
- Post-treatment imaging must demonstrate stability or regression of the brain metastases.
- Must have and be willing to submit a prior tumor biopsy or undergo a biopsy during Screening to obtain tumor tissue for submission to a central laboratory for IHC analysis and FISH or qPCR testing.
- Absolute neutrophil count (ANC) >1500/mm3, platelet count >100,000/mm3 within ≤28 days.
- Adequate renal function documented by serum creatinine of ≤1.5 mg/dL or calculated creatinine clearance >50 ml/min within ≤28 days.
- Adequate hepatic function as documented by serum bilirubin <1.5 mg/dL and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 X upper limit of normal (ULN) within ≤28 days.
- Stable cardiac condition with a left ventricular ejection fraction ≥40% within ≤28 days.
- If female of childbearing potential (FOCBP), must have negative serum pregnancy test (serum beta-human chorionic gonadotropin [β-hCG]) within ≤7 days.
- FOCBP and non-sterile male patients with female partner(s) of childbearing potential must agree to use two forms of contraception including one highly effective and one effective method beginning ≥2 weeks prior to enrollment through four months following the last dose of study treatment.
- If male, must agree to no sperm donation during study treatment and for an additional four months following the last dose of study treatment.
- Must have voluntarily signed an informed consent in accordance with institutional policies.
Who cannot join
- Unable to tolerate osimertinib treatment, leading to early treatment discontinuation or prolonged/frequent dosage modifications as determined by the Investigator.
- Received prior gene therapy.
- Other genetic characteristics (such as ALK, ROS, BRAF V600E mutations) which make them a candidate for treatment with other approved targeted therapies.
- Received radiotherapy to the skull, spine, thorax, or pelvis within ≤30 days.
- Active concurrent malignancies, i.e., cancers other than NSCLC that require systemic therapy.
- Active systemic viral, bacterial, or fungal infection(s) requiring treatment.
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- Serious concurrent illness or psychological, familial, sociological, geographical, or other concomitant conditions that, in the opinion of the Investigator, would not permit adequate follow-up and compliance with the study protocol.
- History of myocardial infarction or unstable angina within ≤6 months.
- Known human immunodeficiency virus (HIV) infection or has active hepatitis infection.
- Female who is pregnant or breastfeeding.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 8 recruiting
- Recruiting
Gabrail Cancer Center Research
Canton, Ohio, 44718
Carrie Smith, 330-417-8231, csmith@gabrailcancercenter.com
Kim Roby, 330.492.3345 ext. 227, kroby@gabrailcancercenter.com
- Recruiting
Virginia Cancer Specialists
Fairfax, Virginia, 22031
Carrie Friedman, RN, BSN, OCN, 703-636-1473, carrie.friedman@usoncology.com
Alexander I. Spira, MD
- Terminated
Millennium Oncology
Houston, Texas, 77090
- Recruiting
Markey Cancer Center
Lexington, Kentucky, 40536
Morgan Butler, 859-562-0318, Morgan.Butler@uky.edu
Zhonglin Hao, MD
- Recruiting
Rocky Mountain Cancer Centers
Lone Tree, Colorado, 80124
Katherine Schleich, 303-285-5018 ext. 35018, Katherine.schleich@usoncology.com
Joni Richman, 303-336-2181, joni.richman@usoncology.com
- Recruiting
Valkyrie Clinical Trials
Los Angeles, California, 90067
Kristi Okino, 562-833-1483, Kristi.okino@valkyrieclinicaltrials.com
David Berz, MD
- Recruiting
Virginia Oncology Associates
Norfolk, Virginia, 23502
Tamaura Wilson, RN, BSN, OCN, 757-213-5906, Tamaura.wilson@usoncology.com
Boon Kok, MD
- Recruiting
The Valley Hospital - Luckow Pavilion
Paramus, New Jersey, 07652
Robyn Chicherchia, 201-634-5792, rchiche@valleyhealth.com
Eli D. Kirshner, MD
- Terminated
Maryland Oncology Hematology
Rockville, Maryland, 20850
- Recruiting
Carle Cancer Institute
Urbana, Illinois, 61801
Hannah Parks, 217-326-3150, Hannah.Parks@carle.com
Kendrith Rowland, MD
About this study
Official title: A Phase 1/2 Open-Label, Dose-Escalation and Clinical Response Study of Quaratusugene Ozeplasmid in Combination With Osimertinib in Patients With Advanced, Metastatic EGFR-Mutant, Metastatic Non-Small Cell Lung Cancer
The purpose of this randomized study is to determine the safety and efficacy of quaratusugene ozeplasmid (Reqorsa) added to osimertinib in NSCLC patients with activating EGFR mutations who have progressed while on treatment with osimertinib. Quaratusugene ozeplasmid consists of non-viral lipid nanoparticles that encapsulate a DNA plasmid with the TUSC2 tumor suppressor gene and is the first systemic gene therapy for cancer.
The study is comprised of a Phase 1 dose escalation portion and two Phase 2 portions evaluating safety and efficacy. Enrollment in the Phase 1 dose escalation portion is complete and the recommended Phase 2 dose (RP2D) was determined. Phase 2a has initiated and enrolled patients are treated with quaratusugene ozeplasmid at the RP2D in combination with osimertinib. In Phase 2b, patients will be randomized to receive either quaratusugene ozeplasmid plus osimertinib or platinum-based chemotherapy.
Read the detailed description
Acclaim-1 is an open-label, multi-center, Phase 1/2 study evaluating quaratusugene ozeplasmid (Reqorsa) plus osimertinib (investigational arm) versus platinum-based chemotherapy (control arm) in patients with advanced metastatic or recurrent NSCLC.
Toxicities will be assessed by the Investigator using United States National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Serious Adverse Events and Dose Limiting Toxicities (DLT) will be reviewed by a Safety Review Committee.
Phase 1 - Dose Escalation: The RP2D of quaratusugene ozeplasmid when given in combination with osimertinib has been identified.
Phase 2a: This expansion cohort will be enrolled to better characterize safety, tolerability, and preliminary anti-tumor activity of the combination therapy.
Phase 2b: Quaratusugene ozeplasmid in combination with osimertinib will be further evaluated using the RP2D identified in Phase 1. Patients may receive local therapy, such as radiation therapy, to progressing lesions prior to enrollment. Patients will be randomized to receive either the investigational arm or the control arm in a 1 to 1 ratio and stratified based on prior local radiotherapy.
- Conditions
- Carcinoma, Non-Small Cell Lung
- Being tested
- quaratusugene ozeplasmid, osimertinib, Platinum-Based Chemotherapy
- Keywords
- Epidermal growth factor receptor mutation (EGFR), osimertinib, Tumor suppressor gene 2 (TUSC2), Lipid nanoparticle (LNP), Gene therapy, Tagrisso, FUS1-nanoparticles, NSCLC, Reqorsa, 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 immunogene therapy utilizing the TUSC2 gene, designed to target cancer cells by interrupting cell signaling pathways that allow cancer cells to grow, reestablishing pathways that promote cancer cell death and modulating the immune response against cancer cells.
osimertinibDrug
Also called Tagrisso
Osimertinib is a 3rd generation EGFR tyrosine kinase inhibitor (TKI) oral tablet administered daily, as indicated for treatment of patients with metastatic NSCLC whose tumors have EGFR genetic deletions or mutations.
Platinum-Based ChemotherapyDrug
Also called cisplatin, carboplatin
Cisplatin and carboplatin are intravenously administered platinum agents that are combined with other cytotoxic chemotherapy agents such as pemetrexed.
| Study group | Role | What they receive |
|---|---|---|
| Investigational | Experimental | In Phase 1, Phase 2a and the investigational arm of Phase 2b, patients will receive their assigned dose of quaratusugene ozeplasmid (intravenous administration once every 21 days) plus osimertinib (80 mg fixed dose oral tablet taken daily starting on Day 1 through Day 21 of every 21-day treatment cycle) until disease progression or unacceptable toxicity. Receives: Biological: quaratusugene ozeplasmid; Drug: osimertinib |
| Control | Active comparator | In the control arm of Phase 2b, patients will receive platinum-based chemotherapy until disease progression or unacceptable toxicity. Receives: Drug: Platinum-Based Chemotherapy |
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 maximum tolerated dose (MTD) or, if the MTD is not defined by the safety data, RP2D will be determined based on an integrated assessment of all available clinical safety and preliminary efficacy data.
Measured: First 21-day treatment cycle for each dose level cohort
Overall Response Rate (ORR) - Phase 2a
ORR (complete response [CR]+ partial response [PR]) according to RECIST using best overall response.
Measured: Approximately 3 months
Progression-free Survival (PFS) - Phase 2b
PFS from randomization to disease progression or death. Response according to RECIST.
Measured: Approximately 11 months
Secondary outcomes (14)
Progression-free Survival (PFS) - Phase 1
PFS from first dose to disease progression or death. Response according to RECIST.
Measured: Approximately 9 months
Overall Response Rate (ORR) - Phase 1
ORR (CR+ PR) according to RECIST using best overall response.
Measured: Approximately 3 months
Duration of Response (DOR) - Phase 1
DOR (CR + PR) from response to disease progression. Response according to RECIST.
Measured: Approximately 9 months
Pharmacokinetics (PK) of Quaratusugene Ozeplasmid - Phase 1
Concentration of quaratusugene ozeplasmid in whole blood samples.
Measured: First 21-day treatment cycle
Progression-free Survival (PFS) - Phase 2a
PFS from first dose to disease progression or death. Response according to RECIST.
Measured: Approximately 11 months
Time to Progression (TTP) - Phase 2a
TTP from first dose to disease progression. Response according to RECIST.
Measured: Approximately 11 months
Overall Survival (OS) - Phase 2a
OS from first dose until death or discontinuation due to withdrawal of consent.
Measured: Approximately 21 months
Pharmacokinetics (PK) of Quaratusugene Ozeplasmid - Phase 2a
Concentration of quaratusugene ozeplasmid in whole blood samples.
Measured: Approximately 22 days
Overall Response Rate (ORR) - Phase 2b
ORR (CR+ PR) according to RECIST using best overall response.
Measured: Approximately 3 months
Time to Progression (TTP) - Phase 2b
TTP from first dose to disease progression. Response according to RECIST.
Measured: Approximately 11 months
Duration of Response (DOR) - Phase 2b
DOR (CR + PR) according to RECIST from response to disease progression.
Measured: Approximately 11 months
Overall Survival (OS) - Phase 2b
OS from randomization to death or discontinuation due to withdrawal of consent.
Measured: Approximately 21 months
Incidence of Adverse Events - Phase 2b
Treatment-related adverse events (AEs) graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events.
Measured: Approximately 11 months
Pharmacokinetics (PK) of Quaratusugene Ozeplasmid - Phase 2b
Concentration of quaratusugene ozeplasmid in whole blood samples.
Measured: Approximately 22 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start3 Sep 2021
- Primary completionMar 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Non-Small Cell LungStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Phase 1: 3+3 dose escalation to identify RP2D. Phase 2: RP2D further evaluated in Phase 2a expansion followed by parallel randomization in a 1:1 ratio to either investigational arm or control arm.
- Masking
- None (open label)
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genprex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark S. Berger, MD, Study director, Genprex, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04486833
- Sponsor's protocol ID
- ONC-003
- Acronym
- Acclaim-1
- Status last verified
- Sep 2026
- First submitted
- 22 Jul 2020
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Spira AI, Berz D, Jotte RM, Pachipala KK, Berger MS. Dose Escalation Trial of the Combination of Osimertinib and Quaratusugene Ozeplasmid Gene Therapy in Patients with Advanced NSCLC. Clin Lung Cancer. 2026 Jan;27(1):75-81. doi: 10.1016/j.cllc.2025.11.009. Epub 2025 Nov 17.
PubMed 41385873
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 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 Osimertinib in Patients With Advanced, Metastatic EGFR-Mutant, Metastatic Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04486833
- Acronym / sponsor ID
- Acclaim-1 / ONC-003
- Conditions
- Carcinoma, Non-Small Cell Lung
- Keywords
- Epidermal growth factor receptor mutation (EGFR), osimertinib, Tumor suppressor gene 2 (TUSC2), Lipid nanoparticle (LNP), Gene therapy, Tagrisso, FUS1-nanoparticles, NSCLC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Genprex, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Sep 2021 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 27 Jul 2020 (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 randomized study is to determine the safety and efficacy of quaratusugene ozeplasmid (Reqorsa) added to osimertinib in NSCLC patients with activating EGFR mutations who have progressed while on treatment with osimertinib. Quaratusugene ozeplasmid consists of non-viral lipid nanoparticles that encapsulate a DNA plasmid with the TUSC2 tumor suppressor gene and is the first systemic gene therapy for cancer.
The study is comprised of a Phase 1 dose escalation portion and two Phase 2 portions evaluating safety and efficacy. Enrollment in the Phase 1 dose escalation portion is complete and the recommended Phase 2 dose (RP2D) was determined. Phase 2a has initiated and enrolled patients are treated with quaratusugene ozeplasmid at the RP2D in combination with osimertinib. In Phase 2b, patients will be randomized to receive either quaratusugene ozeplasmid plus osimertinib or platinum-based chemotherapy.
Detailed description
Acclaim-1 is an open-label, multi-center, Phase 1/2 study evaluating quaratusugene ozeplasmid (Reqorsa) plus osimertinib (investigational arm) versus platinum-based chemotherapy (control arm) in patients with advanced metastatic or recurrent NSCLC.
Toxicities will be assessed by the Investigator using United States National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Serious Adverse Events and Dose Limiting Toxicities (DLT) will be reviewed by a Safety Review Committee.
Phase 1 - Dose Escalation: The RP2D of quaratusugene ozeplasmid when given in combination with osimertinib has been identified.
Phase 2a: This expansion cohort will be enrolled to better characterize safety, tolerability, and preliminary anti-tumor activity of the combination therapy.
Phase 2b: Quaratusugene ozeplasmid in combination with osimertinib will be further evaluated using the RP2D identified in Phase 1. Patients may receive local therapy, such as radiation therapy, to progressing lesions prior to enrollment. Patients will be randomized to receive either the investigational arm or the control arm in a 1 to 1 ratio and stratified based on prior local radiotherapy.
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. Phase 2: RP2D further evaluated in Phase 2a expansion followed by parallel randomization in a 1:1 ratio to either investigational arm or control arm.
| Arm | Type | Receives |
|---|---|---|
| Investigational | Experimental | Biological: quaratusugene ozeplasmid, Drug: osimertinibIn Phase 1, Phase 2a and the investigational arm of Phase 2b, patients will receive their assigned dose of quaratusugene ozeplasmid (intravenous administration once every 21 days) plus osimertinib (80 mg fixed dose oral tablet taken daily starting on Day 1 through Day 21 of every 21-day treatment cycle) until disease progression or unacceptable toxicity. |
| Control | Active comparator | Drug: Platinum-Based ChemotherapyIn the control arm of Phase 2b, patients will receive platinum-based chemotherapy 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.
- Histologically or cytologically documented NSCLC.
- Stage III or IV NSCLC or recurrent NSCLC that is not potentially curable by radiotherapy or surgery.
- The NSCLC must be epidermal growth factor receptor (EGFR) mutation positive-positive based on results from most recent tissue biopsy or most recent evaluation of circulating tumor DNA.
- Achieved clinical response to osimertinib for ≥4 months, which can be a response of stable disease. Must have a minimum of a 10-day osimertinib washout completed at the time of enrollment.
Key exclusion criteria (10 listed)
- Unable to tolerate osimertinib treatment, leading to early treatment discontinuation or prolonged/frequent dosage modifications as determined by the Investigator.
- Received prior gene therapy.
- Other genetic characteristics (such as ALK, ROS, BRAF V600E mutations) which make them a candidate for treatment with other approved targeted therapies.
- Received radiotherapy to the skull, spine, thorax, or pelvis within ≤30 days.
- Active concurrent malignancies, i.e., cancers other than NSCLC that require systemic 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 immunogene therapy utilizing the TUSC2 gene, designed to target cancer cells by interrupting cell signaling pathways that allow cancer cells to grow, reestablishing pathways that promote cancer cell death and modulating the immune response against cancer cells. | Biological | Investigational |
| osimertinibAlso: TagrissoOsimertinib is a 3rd generation EGFR tyrosine kinase inhibitor (TKI) oral tablet administered daily, as indicated for treatment of patients with metastatic NSCLC whose tumors have EGFR genetic deletions or mutations. | Drug | Investigational |
| Platinum-Based ChemotherapyAlso: cisplatin, carboplatinCisplatin and carboplatin are intravenously administered platinum agents that are combined with other cytotoxic chemotherapy agents such as pemetrexed. | Drug | Control |
Primary outcome
Recommended Phase 2 Dose (RP2D) - Phase 1
Time frame: First 21-day treatment cycle for each dose level cohort
RP2D, which will be the maximum tolerated dose (MTD) or, if the MTD is not defined by the safety data, RP2D will be determined based on an integrated assessment of all available clinical safety and preliminary efficacy data.
Overall Response Rate (ORR) - Phase 2a
Time frame: Approximately 3 months
ORR (complete response [CR]+ partial response [PR]) according to RECIST using best overall response.
Progression-free Survival (PFS) - Phase 2b
Time frame: Approximately 11 months
PFS from randomization to disease progression or death. Response according to RECIST.
14 secondary outcomes
Progression-free Survival (PFS) - Phase 1
Time frame: Approximately 9 months
Overall Response Rate (ORR) - Phase 1
Time frame: Approximately 3 months
Duration of Response (DOR) - Phase 1
Time frame: Approximately 9 months
Pharmacokinetics (PK) of Quaratusugene Ozeplasmid - Phase 1
Time frame: First 21-day treatment cycle
Progression-free Survival (PFS) - Phase 2a
Time frame: Approximately 11 months
Time to Progression (TTP) - Phase 2a
Time frame: Approximately 11 months
Overall Survival (OS) - Phase 2a
Time frame: Approximately 21 months
Pharmacokinetics (PK) of Quaratusugene Ozeplasmid - Phase 2a
Time frame: Approximately 22 days
Overall Response Rate (ORR) - Phase 2b
Time frame: Approximately 3 months
Time to Progression (TTP) - Phase 2b
Time frame: Approximately 11 months
Duration of Response (DOR) - Phase 2b
Time frame: Approximately 11 months
Overall Survival (OS) - Phase 2b
Time frame: Approximately 21 months
Incidence of Adverse Events - Phase 2b
Time frame: Approximately 11 months
Pharmacokinetics (PK) of Quaratusugene Ozeplasmid - Phase 2b
Time frame: Approximately 22 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Background: PubMed 41385873Spira AI, Berz D, Jotte RM, Pachipala KK, Berger MS. Dose Escalation Trial of the Combination of Osimertinib and Quaratusugene Ozeplasmid Gene Therapy in Patients with Advanced NSCLC. Clin Lung Cancer. 2026 Jan;27(1):75-81. doi: 10.1016/j.cllc.2025.11.009. Epub 2025 Nov 17.
- Dose Escalation Trial of the Combination of Osimertinib and Quaratusugene Ozeplasmid Gene Therapy in Patients with Advanced NSCLCLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Mark S. Berger, MD study director
Genprex, Inc.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing quaratusugene ozeplasmid, osimertinib and Platinum-Based Chemotherapy in people with Carcinoma, Non-Small Cell Lung, run by Genprex, Inc. at 10 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 10 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: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sr Director, Clinical Operations (1-877-774-GNPX, kcombs@genprex.com), or a site near the patient. 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-day treatment cycle for each dose level cohort). 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?
On the ClinicalTrials.gov record for NCT04486833, which also lists 1 linked publication.
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 16 Sep 2026.