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New treatment option for Carcinoma, Non-Small Cell Lung
Official title Quaratusugene Ozeplasmid (Reqorsa) and Osimertinib in Patients With Advanced Lung Cancer Who Progressed on Osimertinib
ClinicalTrials.gov ID: NCT04486833
What this study is testing
What is quaratusugene ozeplasmid?
quaratusugene ozeplasmid is an investigational medicine, being studied as a potential treatment for carcinoma, non-small cell lung.
Also referred to as Reqorsa.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- Unable to tolerate osimertinib treatment, leading to early treatment discontinuation or prolonged/frequent dosage modifications as determined by the...
- 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...
- 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.
See the full eligibility 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...
- 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...
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Lone Tree, Colorado, United States
- Urbana, Illinois, United States
- Lexington, Kentucky, United States
- Rockville, Maryland, United States
- Paramus, New Jersey, United States
- Canton, Ohio, United States
- Houston, Texas, United States
- Fairfax, Virginia, United States
- Norfolk, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Lone Tree, Colorado, United States; Urbana, Illinois, United States; Lexington, Kentucky, United States; Rockville, Maryland, United States; Paramus, New Jersey, United States and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.