Reqorsa (Quaratusugene Ozeplasmid) and Osimertinib in Patients With Advanced Lung Cancer Who Progressed on Osimertinib (Acclaim-1)

  • End date
    Dec 11, 2025
  • participants needed
  • sponsor
    Genprex, Inc.
Updated on 4 October 2022
platelet count
kinase inhibitor
serum bilirubin level
brain metastases
cancer chemotherapy
advanced lung cancer
kidney function test
lung carcinoma


The purpose of this randomized study is to determine the safety and efficacy of Reqorsa (quaratusugene ozeplasmid, formerly known as GPX-001) added to osimertinib in NSCLC patients with activating EGFR mutations who have progressed while on treatment with osimertinib. Reqorsa 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.

The study will be conducted in 2 phases, a dose escalation and expansion phase (Phase 1) and a safety and efficacy evaluation phase (Phase 2). In Phase 1, patients will be enrolled in sequential cohorts treated with successively higher doses of Reqorsa in combination with osimertinib. When the recommended Phase 2 dose (RP2D) is determined, additional patients will be enrolled in an expansion cohort. In Phase 2, patient will be randomized to receive Reqorsa plus osimertinib or osimertinib alone.


Acclaim-1 is an open-label, multi-center, Phase 1/2 study evaluating Reqorsa (quaratusugene ozeplasmid) plus osimertinib versus monotherapy osimertinib in patients with advanced metastatic or recurrent NSCLC.

Toxicities will be assessed by the Investigator using United States National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Serious Adverse Events and Dose Limiting Toxicities (DLT) will be reviewed by a safety review committee.

Phase 1 - Dose Escalation: The RP2D of Reqorsa when given in combination with osimertinib will be identified. Once the RP2D is identified an expansion cohort will be enrolled to better characterize safety, tolerability, and preliminary anti-tumor activity.

Phase 2: Reqorsa in combination with osimertinib will be further evaluated using the RP2D identified in Phase 1. Patients may receive local therapy, such as radiation therapy, to progressing lesions prior to enrollment. Patients will be randomized to receive either combination therapy or osimertinib alone in a 1 to 1 ratio and stratified based on prior local radiotherapy. Other subsets may be explored based on emergent data.

Condition Carcinoma, Non-Small Cell Lung
Treatment Osimertinib, Osimertinib Oral Tablet, Quaratusugene ozeplasmid - intravenous infusion, quaratusugene ozeplasmid
Clinical Study IdentifierNCT04486833
SponsorGenprex, Inc.
Last Modified on4 October 2022


Yes No Not Sure

Inclusion Criteria

Histologically or cytologically documented non-small cell lung cancer (NSCLC)
Stage III or IV NSCLC or recurrent NSCLC that is not potentially curable by radiotherapy or surgery whether or not patient has received prior chemotherapy
EGFR mutation-positive as detected by an FDA-approved test, based on results of most recent biopsy
Achieved clinical response to osimertinib for ≥4 months
Must have radiological progression on or after treatment with osimertinib and can have either asymptomatic disease or symptomatic disease. For Phase 2 only, eligibility for patients with symptomatic disease is restricted to those with limited metastasis (≤5 metastases)
Eastern Cooperative Oncology Arm (ECOG) performance score from 0 to 1
Must be ≥28 days beyond major surgical procedures such as thoracotomy, laparotomy, or joint replacement, and must be ≥10 days beyond minor surgical procedures such as biopsy of subcutaneous tumors, pleuroscopy, etc., and must not have evidence of wound dehiscence, active wound infection, or comparable major residual complications of the surgery
If asymptomatic brain metastases are present must meet ALL criteria listed
No history of seizures in the preceding 6 months
Definitive treatment must be completed ≥21 days
Patients 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
ANC >1500/mm3, platelet count >100,000/mm3 within ≤21 days
Adequate renal function documented by serum creatinine of ≤1.5 mg/dL or calculated creatinine clearance >50 ml/min within ≤21 days
Adequate hepatic function as documented by serum bilirubin <1.5 mg/dL and AST and ALT ≤2.5 X upper limit of normal (ULN) within ≤21 days
Stable cardiac condition with a left ventricular ejection fraction ≥40% within ≤21 days
If female of childbearing potential, must have negative serum pregnancy test (serum β-hCG) within ≤7 days
Must agree to 2 forms of contraception including 1 highly effective and 1 effective methods during the study period and for 4 months following the last dose of study treatment
If male, must agree to no sperm donation during study treatment and for an additional 4 months following the last dose of study treatment
Must have voluntarily signed an informed consent in accordance with institutional policies

Exclusion Criteria

Unable to tolerate osimertinib treatment, leading to early treatment discontinuation or prolonged/frequent dosage modifications
Received standard chemotherapy or monoclonal antibodies to treat NSCLC within ≤21 days
Received prior gene therapy
Other genetic characteristics (such as ALK, ROS, BRAF V600E mutations) which makes them a candidate for treatment with other approved targeted therapies
Received radiotherapy to the skull, spine, thorax, or pelvis within ≤30 days
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 study protocol
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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note