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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
Eastern Cooperative Oncology Group performance status (ECOG PS) score from 0 to 1
Must have radiological progression on osimertinib treatment and measurable disease per RECIST 1.1. Patients can have either asymptomatic disease or symptomatic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 21 months
Awards & highlights

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.

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.

Acclaim-1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer has grown despite taking osimertinib, and it can be measured by scans.
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I am 18 years old or older.
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My lung cancer diagnosis was confirmed through lab tests.
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My lung cancer is advanced and cannot be cured with surgery or radiation.
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My lung cancer has a positive EGFR mutation based on recent tests.
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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.
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I am willing to provide previous tumor samples for testing.
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I had major surgery over 28 days ago or minor surgery over 10 days ago, with no complications.

Acclaim-1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 21 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 21 months for reporting.

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 more

Side effects data

From 2022 Phase 2 trial • 17 Patients • NCT03434418
76%
Diarrhea
53%
Fatigue
41%
Anorexia
41%
Weight loss
35%
Dyspnea
29%
Abdominal pain
29%
Vomiting
24%
Maculopapular rash
24%
Acneiform rash
24%
Cough
6%
Respiratory failure
6%
Thromboembolic event
100%
80%
60%
40%
20%
0%
Study treatment Arm
Osimertinib

Acclaim-1 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

Osimertinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04486833 — Phase 1 & 2
Non-Small Cell Lung Cancer Research Study Groups: Investigational, Control
Non-Small Cell Lung Cancer Clinical Trial 2023: Osimertinib Highlights & Side Effects. Trial Name: NCT04486833 — Phase 1 & 2
Osimertinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04486833 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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"

Answered by AI

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."

Answered by AI

Is this trial exclusive to the United States, or are other countries included as well?

"There are a total of 10 sites for this study, with 3 being New york Oncology Hematology, P.C. in Albany, Virginia Cancer Specialists in Fairfax, and Valkyrie Clinical Trials in Los Angeles."

Answered by AI

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."

Answered by AI
~79 spots leftby Dec 2026