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

Study acronym: Acclaim-1
StatusRecruiting
PhasePhase 1/2
Started2021-09-03
View on ClinicalTrials.gov ↗
The purpose of this randomized study is to determine the safety and efficacy of quaratusugene ozeplasmid (Reqorsa) added to osimertinib in NSCLC patients with activating EGFR mutations who have progressed while on treatment with osimertinib. Quaratusugene ozeplasmid 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 is comprised of a Phase 1 dose escalation portion and two Phase 2 portions evaluating safety and efficacy. Enrollment in the Phase 1 dose escalation portion is complete and the recommended Phase 2 dose (RP2D) was determined. Phase 2a has initiated and enrolled patients are treated with quaratusugene ozeplasmid at the RP2D in combination with osimertinib. In Phase 2b, patients will be randomized to receive either quaratusugene ozeplasmid plus osimertinib or platinum-based chemotherapy.

Amendment record

Amended 23 times since 2020-07-22; most recent filed 2026-01-20. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-30.

2026-01-20
Amendment Study Status, References v23
2026-01-12
Amendment Study Status, Contacts/Locations v22
2025-11-04
Amendment Study Status, Contacts/Locations v21
2025-10-14
Amendment Study Status, Contacts/Locations v20
2025-03-21
Amendment Study Status, Contacts/Locations v19
2025-02-20
Amendment Study Status, Study Description, Study Design, Eligibility v18
2024-10-15
Amendment Study Status, Study Description, Outcome Measures, Eligibility v17
2024-06-25
Amendment Study Status, Contacts/Locations v16
2024-02-27
Amendment Study Status, Eligibility, Contacts/Locations v15
2023-06-01
Amendment Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures v14
2023-02-15
Amendment Study Status, Contacts/Locations v13
2022-11-28
Amendment Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility v12
2022-08-01
Amendment Study Status, Contacts/Locations v11
2022-07-06
Amendment Study Status, Contacts/Locations v10
2022-07-01
Amendment Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility v9
2022-04-20
Amendment Study Status, Contacts/Locations v8
2022-04-07
Amendment Study Status, Contacts/Locations v7
2022-02-15
Amendment Study Identification, Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Contacts/Locations, IPDSharing v6
2021-12-08
Amendment Study Status, Eligibility, Contacts/Locations v5
2021-09-06
Amendment Not Yet Recruiting→Recruiting Study Identification, Study Status, Contacts/Locations v4
2021-06-30
Amendment Study Status, Oversight, Study Description, Conditions, Study Design, Arms and Interventions, Eligibility v3
2020-08-06
Amendment Study Status v2
2020-07-24
Amendment Study Status, Outcome Measures v1
2020-07-22
Original filing
Trial Details
NCT Number NCT04486833
Lead Sponsor Genprex, Inc.
Conditions Carcinoma, Non-Small Cell Lung
Enrollment 158 participants
Start Date 2021-09-03
Primary Completion 2028-03 (estimated)
Study Completion 2029-03 (estimated)
Updated on ClinicalTrials.gov 2026-01-21