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New gene therapy combo aims to keep advanced lung cancer in check

NCT ID NCT05703971

Disease control Sponsor: Genprex, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

This study tests a new gene therapy (quaratusugene ozeplasmid) plus an immunotherapy drug (atezolizumab) as maintenance treatment for people with extensive stage small cell lung cancer. The goal is to see if the combination can keep the cancer from growing longer than standard care. About 62 adults who have already responded to initial chemo-immunotherapy will take part. The trial has two phases: first finding the best dose, then checking safety and effectiveness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 62 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2024

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. * Must be ≥28 days beyond major surgical procedures such as thoracotomy, laparotomy, or joint replacement, and must not have evidence of wound dehiscence, active wound infection, or comparable major residual complications of the surgery per Investigator assessment. * Asymptomatic brain metastases must meet ALL criteria of the following (a-d): 1. No history of seizures in the preceding six months. 2. Definitive treatment must be completed ≥21 days prior to enrollment. 3. Must be off steroids administered because of brain metastases or related symptoms for ≥7 days. 4. If had previous brain irradiation, post-treatment imaging must demonstrate stability or regression of the brain metastases. * Absolute neutrophil count (ANC) \>1500/mm3, platelet count \>100,000/mm3 within ≤28 days. * Adequate renal function documented by serum creatinine of ≤1.5 mg/dL or calculated creatinine clearance \>50 ml/min within ≤28 days. * Adequate hepatic function as documented by serum bilirubin \<1.5 mg/dL and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 X upper limit of normal (ULN) within ≤28 days. * Stable cardiac condition with a left ventricular ejection fraction ≥40% within ≤28 days. * If female of childbearing potential (FOCBP), must have negative serum pregnancy test (serum beta-human chorionic gonadotropin \[β-hCG\]) within ≤7 days of first dose. * FOCBP and non-sterile men who are sexually active with FOCBP must agree to use two forms of contraception including one highly effective and one effective methods beginning ≥2 weeks prior to enrollment through for four months following the last dose of study treatment. * If male, must agree to no sperm donation during study treatment and for an additional four 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 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. * 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 autoimmune disease requiring immunosuppression. * 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

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Conditions

The condition(s) this trial relates to.

small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Small cell lung cancer extensive stage

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    16 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Gabrail Cancer Center Research

    RECRUITING

    Canton, Ohio, 44718, United States

  • Northwest Cancer Specialists, P.C.

    RECRUITING

    Portland, Oregon, 97213-2982, United States

  • Northwest Cancer Specialists, P.C.

    RECRUITING

    Portland, Oregon, 97227, United States

  • Northwest Cancer Specialists, P.C.

    RECRUITING

    Tigard, Oregon, 97223, United States

  • Northwest Cancer Specialists, P.C.

    TERMINATED

    Vancouver, Washington, 98684, United States

  • Oncology_Hematology Care Clinical Trials, LLC

    RECRUITING

    Cincinnati, Ohio, 45211, United States

  • Oncology_Hematology Care Clinical Trials, LLC

    RECRUITING

    Cincinnati, Ohio, 45236, United States

  • Oncology_Hematology Care Clinical Trials, LLC

    RECRUITING

    Cincinnati, Ohio, 45242, United States

  • Oncology_Hematology Care Clinical Trials, LLC

    RECRUITING

    Cincinnati, Ohio, 45245, United States

  • Oncology_Hematology Care Clinical Trials, LLC

    RECRUITING

    Fairfield, Ohio, 45014, United States

  • Providence Cancer Institute

    RECRUITING

    Portland, Oregon, 97213, United States

    Contact Email: •••••@•••••

  • Rocky Mountain Cancer Centers, LLP

    RECRUITING

    Lone Tree, Colorado, 80124, United States

  • Texas Oncology - DFW

    RECRUITING

    Dallas, Texas, 75246, United States

  • Texas Oncology - Northeast Texas

    RECRUITING

    Tyler, Texas, 75702, United States

  • Virginia Cancer Specialists, PC

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Washington University School of Medicine - Siteman Cancer Center

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Willamette Valley Cancer Institute (Oregon)

    RECRUITING

    Eugene, Oregon, 97401, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.