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Tyrosine Kinase Inhibitor
Reqorsa + Osimertinib for Advanced Lung Cancer (Acclaim-1 Trial)
Phase 1 & 2
Recruiting
Research Sponsored by Genprex, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 21 months
Awards & highlights
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.
Who is the study for?
This trial is for adults with advanced non-small cell lung cancer (NSCLC) who have previously responded to osimertinib but now show disease progression. Participants must have adequate organ function, no recent major surgeries, controlled brain metastases if present, and agree to use two forms of contraception. Those with HIV, active hepatitis, or other mutations treatable by approved therapies are excluded.Check my eligibility
What is being tested?
The study tests quaratusugene ozeplasmid (Reqorsa), a gene therapy combined with osimertinib versus platinum-based chemotherapy in NSCLC patients after osimertinib failure. It includes dose escalation to find the safest effective dose followed by safety and efficacy evaluations comparing the new combination against standard chemotherapy.See study design
What are the potential side effects?
Potential side effects may include typical reactions associated with gene therapy such as immune responses leading to inflammation or fever, as well as those related to osimertinib like diarrhea and rash. Chemotherapy can cause nausea, fatigue, hair loss, and increased risk of infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 21 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 21 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate (ORR) - Phase 2a
Progression-free Survival (PFS) - Phase 2b
Recommended Phase 2 Dose (RP2D) - Phase 1
Secondary outcome measures
Duration of Response (DOR) - Phase 2b
Incidence of Adverse Events - Phase 2b
Overall Response Rate (ORR) - Phase 1
+8 moreSide effects data
From 2022 Phase 2 trial • 17 Patients • NCT0343441876%
Diarrhea
53%
Fatigue
41%
Weight loss
41%
Anorexia
35%
Dyspnea
29%
Vomiting
29%
Abdominal pain
24%
Acneiform rash
24%
Cough
24%
Maculopapular rash
6%
Thromboembolic event
6%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Osimertinib
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: InvestigationalExperimental Treatment2 Interventions
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.
Group II: ControlActive Control1 Intervention
In the control arm of Phase 2b, patients will receive platinum-based chemotherapy until disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
osimertinib
2018
Completed Phase 2
~150
Find a Location
Who is running the clinical trial?
Genprex, Inc.Lead Sponsor
3 Previous Clinical Trials
267 Total Patients Enrolled
Michael RedmanStudy DirectorExecutive VP and COO
Mark S. Berger, MDStudy DirectorGenprex, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Investigational
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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