Phase 2 Lung Cancer Trial, Recruiting NCT05703971 Sponsor: Genprex, Inc. Condition: Lung Cancer
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Phase 2 Lung Cancer Trial, Recruiting

NCT05703971
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults aged 18 or older.
  • People who have been diagnosed with extensive-stage small cell lung cancer (ES-SCLC), confirmed by a laboratory test on a tissue or cell sample, before starting the combination treatment of atezolizumab, carboplatin, and etoposide.
  • People whose cancer responded to treatment (completely, partially, or remained stable) after receiving at least three but no more than four cycles of atezolizumab, carboplatin, and etoposide.
  • People with a good general health and activity level, rated 0 or 1 on a standard medical scale used in cancer trials (confirm with trial site).
  • People who have had major surgery (such as chest, abdominal, or joint surgery) at least 28 days before joining, with no signs of wound complications or infection.
  • People with brain metastases that are not causing symptoms, provided all of the following apply: no seizures in the past six months; any treatment for the brain metastases was completed at least 21 days before joining; no steroid use related to brain metastases for at least 7 days; and if the brain was previously treated with radiation, follow-up scans must show the metastases are stable or have shrunk.
  • People with blood test results within the past 28 days showing healthy enough levels of white blood cells and platelets.
  • People with kidney function test results within the past 28 days showing the kidneys are working well enough (confirm with trial site for specific values).
  • People with liver function test results within the past 28 days showing the liver is working well enough (confirm with trial site for specific values).
  • People with a heart that is pumping well enough, confirmed by a heart scan within the past 28 days (confirm with trial site for specific values).
  • Women who could become pregnant must have a negative pregnancy blood test within 7 days before the first dose.
  • Women who could become pregnant, and men who are sexually active with women who could become pregnant, must agree to use two forms of contraception (one highly effective and one effective method) starting at least 2 weeks before joining and continuing for four months after the last dose.
  • Men must agree not to donate sperm during the study and for four months after the last dose.
  • People who have voluntarily signed a consent form agreeing to take part, in line with the institution's requirements.

Who may not be able to join:

  • People who were unable to tolerate atezolizumab during their previous treatment, leading to early stopping or frequent dose changes, as assessed by the treating doctor.
  • People who have previously received gene therapy.
  • People who have received preventive brain radiation (prophylactic cranial irradiation) or consolidation radiation to the chest.
  • People who currently have an active viral, bacterial, or fungal infection that requires treatment.
  • People with serious other illnesses, or personal, family, social, or geographical circumstances that the treating doctor believes would prevent proper participation in the study.
  • People with a history of an autoimmune disease that required immune-suppressing treatment.
  • People who have had a heart attack or unstable chest pain within the past 6 months.
  • People known to have HIV, or who have an active hepatitis infection.
  • Women who are pregnant or breastfeeding.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 16 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Mark S Berger, MD, Genprex, Inc.

Phone: 1-877-774-GNPX

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Genprex, Inc.
Registry
ClinicalTrials.gov
Start date
9 May 2024
Est. completion
1 June 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) - Phase 1; Progression-Free Survival Rate (PFSR) - Phase 2

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 16 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov