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Checkpoint Inhibitor
Reqorsa + Pembrolizumab for Lung Cancer (Acclaim-2 Trial)
Phase 1 & 2
Recruiting
Led By Daniel Morgensztern, MD
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 11 months
Awards & highlights
Acclaim-2 Trial Summary
This trial is studying a gene therapy called Reqorsa given with the drug pembrolizumab to see if it can help to treat patients with previously treated non-small cell lung cancer.
Who is the study for?
Adults over 18 with previously treated non-small cell lung cancer (NSCLC) who have had some benefit from prior treatments like pembrolizumab or chemotherapy, but whose disease has progressed. They must not be pregnant, agree to use contraception, and should not have serious health issues that could interfere with the trial.Check my eligibility
What is being tested?
The trial is testing quaratusugene ozeplasmid (Reqorsa), a gene therapy combined with pembrolizumab, against standard treatments. It's in two phases: first to find the right dose and then to check its safety and effectiveness compared to other options.See study design
What are the potential side effects?
Possible side effects include typical reactions related to gene therapies such as immune responses or inflammation at injection sites, as well as those associated with pembrolizumab like fatigue, skin reactions, or flu-like symptoms.
Acclaim-2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 11 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 11 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free Survival (PFS) - Phase 2 Randomized
Recommended Phase 2 Dose (RP2D) - Phase 1
Secondary outcome measures
Adverse Events (AEs) - Phase 2 Dose Expansion
Adverse Events (AEs) - Phase 2 Randomized
Disease Control Rate (DCR) - Phase 2 Randomized
+10 moreSide effects data
From 2022 Phase 3 trial • 1274 Patients • NCT0222089412%
Weight decreased
9%
Aspartate aminotransferase increased
9%
Arthralgia
9%
Constipation
9%
Haemoptysis
9%
Diarrhoea
9%
Hypothyroidism
9%
Decreased appetite
9%
Alanine aminotransferase increased
9%
Nasopharyngitis
9%
Bronchitis
6%
Anaemia
6%
Cough
6%
Asthenia
6%
Pruritus
6%
Pneumonia
6%
Headache
6%
Blood alkaline phosphatase increased
3%
Rash
3%
Leukopenia
3%
Hyperglycaemia
3%
Pneumonia bacterial
3%
Myalgia
3%
Subdural haemorrhage
3%
Nausea
3%
Malaise
3%
White blood cell count decreased
3%
Tumour associated fever
3%
Upper respiratory tract infection
3%
Hypertension
3%
Pyrexia
3%
Dyspnoea
3%
Lymph gland infection
3%
Back pain
3%
Chest pain
3%
Haematemesis
3%
Hyperthyroidism
3%
Upper gastrointestinal haemorrhage
3%
Oedema peripheral
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab Second Course
Pembrolizumab
Chemotherapy (SOC Treatment)
Acclaim-2 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: InvestigationalExperimental Treatment2 Interventions
In Phase 1, the dose expansion portion of Phase 2 and the investigational arm of the randomized portion of Phase 2, patients will receive their assigned dose of quaratusugene ozeplasmid (via intravenous infusion) in combination with a fixed 200 mg dose of pembrolizumab (via intravenous infusion) once in every 21-day treatment cycle until disease progression or unacceptable toxicity.
Group II: ControlActive Control3 Interventions
In the control arm of the randomized portion of Phase 2, patients will receive either 75 mg/m2 docetaxel (via intravenous infusion) with or without 10 mg/kg ramucirumab (via intravenous infusion) -OR- investigator's choice of treatment. The treatment regimen for patients randomized to the control arm, must begin at Cycle 1 Day 1 and continue every 21 days until disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
pembrolizumab
2017
Completed Phase 3
~5750
Find a Location
Who is running the clinical trial?
Genprex, Inc.Lead Sponsor
3 Previous Clinical Trials
245 Total Patients Enrolled
Daniel Morgensztern, MDPrincipal InvestigatorWashington University School of Medicine
3 Previous Clinical Trials
170 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an autoimmune disease.I have not received a live-virus vaccine in the last month.I had to stop or frequently change my pembrolizumab treatment because I couldn't tolerate it.I have another cancer that hasn't been treated yet.I am 18 years old or older.I am currently being treated for a serious infection.I will not need other cancer treatments during the study.I haven't had chemotherapy or antibody treatment for my advanced cancer in the last 21 days.I am not allergic to docetaxel or polysorbate 80.I am at risk of tumor lysis syndrome due to kidney issues, high uric acid, or a large tumor.I have received gene therapy before.My lung cancer is confirmed by lab tests and has spread.I am fully active or can carry out light work.I have had lung inflammation that needed steroids for treatment.I have active brain metastases or cancer in my brain's lining.I have HIV or an active hepatitis infection.I agree not to donate sperm during and for 4 months after the study.I do not have any active cancer other than non-small cell lung cancer.My cancer responded to initial treatment with pembrolizumab or pembrolizumab/platinum but has now worsened.I have not had a heart attack or unstable chest pain in the last 6 months.I have moderate to severe nerve damage in my hands or feet.I am not pregnant or breastfeeding.I am not on high-dose steroids or other immune-weakening drugs.My latest tumor biopsy was sent for special testing.I am a woman who can have children and have a recent negative pregnancy test.My cancer progressed after initially responding to pembrolizumab or pembrolizumab/platinum therapy.My cancer progressed after treatment for specific genetic changes and I can receive immunotherapy.I had major surgery over 28 days ago, or minor surgery over 10 days ago, with no complications.I haven't had radiotherapy to major body areas within the last month, but may have had limited treatment to an arm or leg.I have brain metastases with no seizures in the last 6 months, completed treatment over 4 weeks ago, stopped steroids for over 2 weeks, and my scans show no growth.My recent blood tests show my organs are functioning well.My cancer progressed after treatment for specific genetic changes and I can receive immunotherapy.My hemoglobin level is at least 9.0 g/dL without needing transfusions for the last 4 weeks.I am 18 years old or older.My lung cancer is advanced or has spread, confirmed by lab tests.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Investigational
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What other immunotherapy drugs has pembrolizumab been tested with?
"Pembrolizumab is being researched in 1344 active trials, with 250 of those in Phase 3. New Lambton Heights, New South Wales has the most pembrolizumab clinical trials underway, but there are 57228 total locations for these studies."
Answered by AI
Are there any open slots left for people who want to participate in this experiment?
"Yes, this clinical trial is recruiting patients as of September 12th, 2022. The initial posting was on March 30th, 2020."
Answered by AI
What is the maximum number of people allowed to enroll in this clinical trial?
"One hundred and fifty-six patients, who fit the prerequisites for this experiment, are necessary to enroll. People can sign up for this research at various clinical sites, such as Moffitt Cancer Center - Magnolia Campus in Tampa, Florida or Millennium Oncology in Houston, Texas."
Answered by AI
Who else is applying?
What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Millennium Oncology
What portion of applicants met pre-screening criteria?
Met criteria
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