Quaratusugene Ozeplasmid (Reqorsa) and Atezolizumab Maintenance Therapy in ES-SCLC Patients
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGenprex, Inc.
About this trial
This clinical trial will evaluate the combination of quaratusugene ozeplasmid with atezolizumab as maintenance therapy for patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC).
The study is comprised of 2 phases, a dose selection phase (Phase 1) and a safety and efficacy evaluation phase (Phase 2).
Eligibility criteria
Qualifiers
Male or female aged ≥18 years.
Documented history of histologically or cytologically confirmed ES-SCLC, prior to starting treatment with the combination of atezolizumab, carboplatin, and etoposide
Complete Response (CR), Partial Response (PR), or Stable Disease (SD) after receiving at least three cycles, and no more than four cycles, of atezolizumab, carboplatin, and etoposide.
Eastern Cooperative Oncology Group performance status (ECOG PS) score from 0 to 1.
Disqualifiers
Unable to tolerate atezolizumab treatment, leading to early treatment discontinuation or prolonged/frequent dosage modifications in previous atezolizumab treatment as determined by the Investigator.
Received prior gene therapy.
Received prophylactic cranial irradiation or consolidation thoracic radiation.
Active systemic viral, bacterial, or fungal infection(s) requiring treatment.
Trial design
Treatments tested in this trial
- quaratusugene ozeplasmid
- atezolizumab
Treatment groups
62 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov