Quaratusugene ozeplasmid - intravenous infusion for Carcinoma, Non-Small-Cell Lung

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Carcinoma, Non-Small-Cell Lung+1 More
Quaratusugene ozeplasmid - intravenous infusion - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Carcinoma, Non-Small-Cell Lung
  • Non-Small Cell Lung Carcinoma (NSCLC)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Carcinoma, Non-Small-Cell Lung

Study Objectives

3 Primary · 6 Secondary · Reporting Duration: Approximately 24 months

6 months
Duration of Treatment
Approximately 10 months
Incidence of Adverse Events
Approximately 12 months
Overall Response Rate (ORR) for Phase 2 dose
Approximately 21 months
Overall Survival (OS) - Phase 2
Approximately 24 months
Overall Survival (OS) for Phase 2 dose
Approximately 9 months
Overall Response Rate (ORR) - Phase 2
Progression-free Survival (PFS2) - Phase 2
First 21-days at each dose level
Maximum Tolerated Dose (MTD) - Phase 1
Recommended Phase 2 Dose (RP2D) - Phase 1

Trial Safety

Safety Progress

1 of 3

Other trials for Carcinoma, Non-Small-Cell Lung

Trial Design

3 Treatment Groups

Phase 2 Active Comparator
1 of 3
Phase 1
1 of 3
Phase 2 Combination
1 of 3
Active Control
Experimental Treatment

92 Total Participants · 3 Treatment Groups

Primary Treatment: Quaratusugene ozeplasmid - intravenous infusion · No Placebo Group · Phase 1 & 2

Phase 1Experimental Group · 4 Interventions: Osimertinib Oral Tablet, Quaratusugene ozeplasmid - intravenous infusion, osimertinib, quaratusugene ozeplasmid · Intervention Types: Drug, Biological, Drug, Biological
Phase 2 CombinationExperimental Group · 4 Interventions: Osimertinib Oral Tablet, Quaratusugene ozeplasmid - intravenous infusion, osimertinib, quaratusugene ozeplasmid · Intervention Types: Drug, Biological, Drug, Biological
Phase 2 Active ComparatorActiveComparator Group · 2 Interventions: Osimertinib Oral Tablet, osimertinib · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
osimertinib
2017
Completed Phase 2
~140

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: approximately 24 months

Who is running the clinical trial?

Genprex, Inc.Lead Sponsor
2 Previous Clinical Trials
181 Total Patients Enrolled
1 Trials studying Carcinoma, Non-Small-Cell Lung
156 Patients Enrolled for Carcinoma, Non-Small-Cell Lung
Michael RedmanStudy DirectorExecutive VP and COO
Mark S. Berger, MDStudy DirectorGenprex, Inc.

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a histologically or cytologically documented non-small cell lung cancer.
You have non-small cell lung cancer that is not curable by radiotherapy or surgery.
You have achieved a clinical response to osimertinib for ≥4 months.
You have a performance score of 0 to 1.
You are taking steroids for reasons other than brain metastases or related symptoms.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 20th, 2021

Last Reviewed: October 26th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.