Is NCT04486833 recruiting in Lone Tree, CO?

Yes, NCT04486833 is currently recruiting participants at its Lone Tree, CO location. This lung cancer clinical trial is actively enrolling qualified participants.

How do I join the lung cancer clinical trial in Lone Tree?

To join this clinical trial in Lone Tree, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Lone Tree clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Lung Cancer Clinical Trial in Lone Tree, CO

About This Lung Cancer Study in Lone Tree

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 Pha

Sponsor: Genprex, Inc.

Who Can Participate

Inclusion Criteria

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:

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.

Exclusion Criteria

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.

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Lone Tree?

Yes, this clinical trial (NCT04486833) has an active research site in Lone Tree, CO that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Lung Cancer Treatment Options in Lone Tree, CO

If you're searching for lung cancer treatment options in Lone Tree, CO, this clinical trial (NCT04486833) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Lone Tree research site is actively enrolling participants for this phase 1/2 clinical trial. You'll receive care from experienced lung cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all lung cancer clinical trials near you to find additional studies recruiting in your area.

Lung Cancer Clinical Trial in Lone Tree, CO

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