What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include chemotherapy, targeted therapy, and immune checkpoint inhibitors like pembrolizumab. Chemotherapy can cause side effects such as nausea, vomiting, hair loss, fatigue, and increased risk of infection. Targeted therapies, which act on specific genetic mutations, may lead to rash, diarrhea, liver enzyme abnormalities, and fatigue. Immune checkpoint inhibitors like pembrolizumab can cause immune-related side effects, including fatigue, rash, diarrhea, and inflammation of organs such as the lungs (pneumonitis), liver (hepatitis), and endocrine glands (thyroiditis). Gene therapy with TUSC2 tumor suppressor gene, as studied in the Quaratusugene Ozeplasmid trial, may have unique side effects that are still being evaluated, but could potentially include immune responses and inflammation.

What prior FDA approvals exist?

The FDA has approved several treatments for Non-Small Cell Lung Cancer (NSCLC), including targeted therapies and immunotherapies. For instance, selpercatinib and pralsetinib are approved for RET fusion-positive NSCLC, and fam-trastuzumab deruxtecan is approved for HER2 mutation-positive NSCLC. While these treatments focus on specific genetic mutations, gene therapy approaches like Quaratusugene Ozeplasmid, which involves the TUSC2 tumor suppressor gene, represent a novel area of research. Currently, there are no FDA-approved gene therapies specifically for NSCLC, making the Quaratusugene Ozeplasmid trial a pioneering study in this field.

What other types of research exist?

Promising novel alternatives to Quaratusugene Ozeplasmid for NSCLC patients include: 1) Pembrolizumab (Keytruda) combined with other agents such as chemotherapy or targeted therapies, 2) Nivolumab (Opdivo) combined with Ipilimumab (Yervoy), 3) Targeted therapies like Osimertinib (Tagrisso) for EGFR-mutant NSCLC, and 4) Novel agents in clinical trials such as AMG 510 (Sotorasib) targeting KRAS G12C mutations.

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Checkpoint Inhibitor

Reqorsa + Pembrolizumab for Lung Cancer (Acclaim-2 Trial)

Phase 1 & 2

Waitlist Available

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

No Placebo-Only Group

Summary

This trial tests a new gene therapy (Reqorsa) combined with an existing cancer drug (pembrolizumab) in lung cancer patients who have previously benefited from pembrolizumab. The gene therapy delivers a tumor-suppressing gene, while pembrolizumab helps the immune system fight 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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 11 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 11 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 11 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free Survival (PFS) - Phase 2 Randomized

Recommended Phase 2 Dose (RP2D) - Phase 1

Secondary study objectives

Adverse Events (AEs) - Phase 2 Dose Expansion

Adverse Events (AEs) - Phase 2 Randomized

Disease Control Rate (DCR) - Phase 2 Randomized

+10 more

Side effects data

From 2024 Phase 3 trial • 453 Patients • NCT03062358

36%

Aspartate aminotransferase increased

30%

Alanine aminotransferase increased

28%

Blood bilirubin increased

21%

Platelet count decreased

18%

Gamma-glutamyltransferase increased

17%

White blood cell count decreased

17%

Pyrexia

16%

Diarrhoea

15%

Anaemia

15%

Decreased appetite

15%

Rash

14%

Blood alkaline phosphatase increased

14%

Neutrophil count decreased

12%

Hypoalbuminaemia

12%

Pruritus

11%

Cough

11%

Upper respiratory tract infection

10%

Proteinuria

10%

Hypothyroidism

10%

Lymphocyte count decreased

Constipation

Arthralgia

Weight decreased

Abdominal pain

Nausea

Bilirubin conjugated increased

Insomnia

Asthenia

Fatigue

Hyperglycaemia

Hypokalaemia

Hyponatraemia

Hypoproteinaemia

Back pain

Hypertension

Vomiting

Abdominal distension

Blood lactate dehydrogenase increased

Hyperthyroidism

Ascites

Abdominal pain upper

Hepatitis B DNA increased

Malaise

Blood glucose increased

Blood creatinine increased

Upper gastrointestinal haemorrhage

Pneumonia

Dyspepsia

Gastrointestinal haemorrhage

Autoimmune hepatitis

Hepatic failure

Hepatitis E

Influenza

Sepsis

Tumour haemorrhage

Hepatic encephalopathy

Pneumonitis

Dysphonia

100%

80%

60%

40%

20%

Study treatment Arm

Pembrolizumab (First Course) + BSC

Placebo + BSC

Pembrolizumab Second Course

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~5890

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include chemotherapy, immunotherapy, and gene therapy. Chemotherapy targets rapidly dividing cancer cells using drugs like cisplatin and pemetrexed. Immunotherapy, such as pembrolizumab, boosts the immune system's ability to fight cancer by inhibiting checkpoints like PD-1/PD-L1. Gene therapy, like quaratusugene ozeplasmid, introduces genetic material to restore or enhance tumor suppressor genes such as TUSC2. These diverse mechanisms are crucial for NSCLC patients as they provide multiple strategies to combat cancer, potentially improving treatment efficacy and offering alternatives for those who do not respond to conventional therapies.