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Reqorsa + Osimertinib for Advanced Lung Cancer (Acclaim-1 Trial)
Acclaim-1 Trial Summary
This trial is studying a gene therapy called Reqorsa given with the cancer medicine osimertinib to see if it can help to treat patients with non-small cell lung cancer that has progressed after treatment with osimertinib.
Acclaim-1 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 2 trial • 17 Patients • NCT03434418Acclaim-1 Trial Design
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- I am fully active or restricted in physically strenuous activity but can do light work.My cancer has specific genetic mutations treatable with approved drugs.My cancer has grown despite taking osimertinib, and it can be measured by scans.I have undergone gene therapy before.I haven't had a heart attack or unstable chest pain in the last 6 months.I received standard lung cancer treatment within the last 21 days.I have HIV or an active hepatitis infection.My lung cancer diagnosis was confirmed through lab tests.My lung cancer is advanced and cannot be cured with surgery or radiation.My kidney function is good, with creatinine levels at or below 1.5 mg/dL.I am currently being treated for a serious infection.My heart pumps well, with an ejection fraction of 40% or more.My blood tests show enough neutrophils and platelets.I've responded to osimertinib treatment for 4+ months and haven't taken it for at least 10 days.I am willing to provide previous tumor samples for testing.I had radiation therapy on my skull, spine, chest, or pelvis in the last 30 days.I had major surgery over 28 days ago or minor surgery over 10 days ago, with no complications.I am 18 years old or older.I agree not to donate sperm during and for 4 months after the study.I am currently pregnant or breastfeeding.I had to stop or frequently change my osimertinib dose because I couldn't tolerate it.My lung cancer has a positive EGFR mutation based on recent tests.My liver tests are within normal limits.My brain cancer hasn't caused seizures recently, I've finished treatment over 3 weeks ago, haven't used steroids for brain symptoms in over a week, and my scans show no growth.
- Group 1: Investigational
- Group 2: Control
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are patients being recruited for this research project at present?
"The clinical trial is currently admitting 92 patients across 7 sites, as noted on clinicaltrials.gov."
How many people are being included in this research project?
"92 patients that fit the study's requirements are necessary in order for the trial to commence. Genprex, Inc., is sponsoring the research being conducted at New york Oncology Hematology, P.C. (Albany, NY) and Virginia Cancer Specialists (Fairfax, VA), among other locations."
What goals does this research hope to achieve?
"The primary outcome of this trial, which will be measured over a First 21-days at each dose level time frame, is Progression-free Survival (PFS2) - Phase 2. In addition, this trial will be assessing secondary outcomes including Incidence of Adverse Events which is defined as Number of treatment emergent adverse events graded according to the NCI-CTCAE version 5.0 criteria. From first dose of study treatment to 30 days after last dose., Overall Survival (OS) for Phase 2 dose which is defined as Number of months from randomization or date of first dose of study treatment to the date"
What is novel about this clinical trial?
"AstraZeneca's Quaratusugene ozeplasmid - intravenous infusion drug has undergone 29 clinical trials since its initial study in 2013. 603 patients were involved in the Phase 1 & 2 approval process, which took place across 51 countries and 1061 cities."
Does intravenous infusion of Quaratusugene ozeplasmid have a history in clinical trials?
"Currently, there are one hundred and five ongoing clinical trials investigating Quaratusugene ozeplasmid - intravenous infusion. Out of these studies, seventeen have reached Phase 3. Most of the research for Quaratusugene ozeplasmid - intravenous infusion is conducted in Uniondale, New york; however, there are 4,724 other locations running similar investigations."
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