Phase 2 Lung Cancer Trial, Recruiting NCT06248606 Sponsor: Ryan Gentzler, MD Condition: Lung Cancer
Back to Lung Cancer

Phase 2 Lung Cancer Trial, Recruiting

NCT06248606
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:

  • You must be at least 18 years old at the time of signing the consent form.
  • You must be able to sign a consent form agreeing to take part and allowing your health information to be used for the study.
  • You must be generally well enough to carry out normal daily activities with little or no limitation (confirm with trial site for exact fitness level required).
  • You must have been diagnosed with stage IV non-small cell lung cancer (NSCLC), or have had an earlier-stage lung cancer that has now come back and spread to other parts of the body.
  • Your cancer must have a specific genetic change called a KRAS G12C mutation, confirmed through tumor tissue or a blood test.
  • You must have at least one brain tumor that has not yet been treated, measuring at least 2mm, and no single brain tumor larger than 3cm.
  • If you have had a brain tumor surgically removed, you may still be eligible if there are other brain tumors that can be treated with a type of focused radiation called stereotactic radiosurgery (SRS).
  • If a previously treated brain tumor has grown back, you may still be eligible as long as there is no concern about radiation damage to surrounding tissue (confirm with trial site).
  • If you have already received SRS within 4 weeks before joining, you may still be eligible under certain conditions (confirm with trial site).
  • If you have brain tumor symptoms, you may still qualify as long as there is no sign of the brain being dangerously compressed, no seizures in the past 14 days, and any steroid use is at a low, stable dose.
  • Your brain tumors must be suitable for treatment with SRS using specific types of radiation equipment, either before or shortly after starting the study.
  • You must have no medical reasons preventing you from receiving SRS treatment.
  • You may have received no prior treatment, or up to 2 previous rounds of treatment for your cancer (with specific rules about what counts as a prior treatment — confirm with trial site).
  • Your blood, kidney, and liver test results must meet certain minimum health levels within 28 days before joining (confirm with trial site for specific values).
  • If you could become pregnant, you must have a negative pregnancy test within 7 days before starting treatment.
  • If you could become pregnant or father a child, you must agree to either abstain from sexual activity or use effective contraception during the study.
  • If you have HIV and your virus is well-controlled on treatment, you may be eligible.
  • If you have a history of hepatitis B or C, you may be eligible if the virus is undetectable or successfully treated (confirm with trial site).
  • You must be able to understand and follow the study requirements for the full length of the study.

Who may not be able to join:

  • You have previously been treated with a KRAS G12C targeted therapy drug.
  • You currently have an active infection that requires treatment with antibiotics or antiviral medicines (with some exceptions for HIV and hepatitis — confirm with trial site).
  • You have a serious ongoing or recent illness that is not well controlled.
  • You have a heart condition involving a prolonged electrical signal in the heart (called a long QT interval), either currently or from birth (confirm with trial site).
  • You are currently receiving radiation treatment to any part of your body outside the brain at the time of joining the study (you may be eligible after that radiation is finished).
  • You are taking certain medications that strongly affect how the study drug is processed in your body and cannot be switched to a different medication before starting the study (confirm with trial site).
  • You have taken part in another clinical trial or received an experimental drug within 28 days before joining.
  • You are currently pregnant or breastfeeding.
  • You have or have had another type of cancer that could affect your safety or make it harder to assess how well the study treatment is working (your doctor will decide if this applies to you).

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 15 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: Ryan Gentzler, MD, MS, University of Virginia

Phone: 434-924-4251

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
Ryan Gentzler, MD
Registry
ClinicalTrials.gov
Start date
6 August 2024
Est. completion
25 February 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Intracranial disease control rate (DCR)

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: 15 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