Phase 2 Lung Cancer Trial, Recruiting NCT04789681 Sponsor: M.D. Anderson Cancer Center Condition: Lung Cancer
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Phase 2 Lung Cancer Trial, Recruiting

NCT04789681
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:

  • People who are willing and able to give written consent to participate (or have a legal representative do so on their behalf)
  • People with no history of lung cancer who have a small, persistent spot on their lung (seen on at least two CT scans taken 3 or more months apart, with no sign of it shrinking), where a standard cancer prediction tool (Brock University equation) estimates a 10–30% chance it could be cancer
  • People with no history of lung cancer who have a small, persistent spot on their lung (seen on at least two CT scans taken 3 or more months apart, with no sign of it shrinking), where the Brock University prediction tool estimates more than 30% chance of cancer, but a biopsy did not show clear evidence of cancer
  • People who have previously been diagnosed with early-to-intermediate stage non-small cell lung cancer (stages I–III), have completed treatment aimed at curing the cancer, and now have a small, persistent spot on their lung (seen on at least two CT scans taken 3 or more months apart, with no sign of it shrinking), where the Brock University prediction tool estimates a 5–30% chance it could be cancer
  • People who have previously been diagnosed with early-to-intermediate stage non-small cell lung cancer (stages I–III), have completed treatment aimed at curing the cancer, and now have a small, persistent spot on their lung with a greater than 30% estimated cancer probability by the Brock University tool, but a biopsy did not show clear evidence of cancer
  • People who are at least 18 years old at the time of signing consent
  • Male participants who agree to use contraception throughout the treatment period and for 6 months after the last dose, and agree not to donate sperm during this time
  • Female participants who are not pregnant, not breastfeeding, and either cannot become pregnant, or agree to use contraception throughout the treatment period and for at least 6 months after the last dose
  • People who are generally well enough to carry out normal daily activities with little to no limitation, as measured by a standard medical scoring tool called the ECOG performance scale (scores 0–1), assessed within 7 days before starting treatment
  • People whose recent blood test results (taken within 10 days before starting treatment) show that their immune cells, platelets, and red blood cells are at acceptable levels, without recent blood transfusions or reliance on red blood cell stimulating injections
  • People whose recent blood tests show that their kidneys are functioning at an acceptable level (within 10 days before starting treatment)
  • People whose recent blood tests show that their liver function (including bilirubin and liver enzymes) is within acceptable ranges (within 10 days before starting treatment)

Who may not be able to join:

  • Women who could become pregnant and return a positive pregnancy test within 72 hours before starting treatment
  • People who have previously received treatment with a medication that targets a substance called IL-1 beta (an inflammation-related protein in the body)
  • People who have another cancer that is currently growing or that has required active treatment within the past year (note: people who have had certain skin cancers or very early-stage cancers treated with curative intent are not automatically excluded — confirm with trial site)
  • People who currently have an active infection that requires treatment with medications taken throughout the body (such as antibiotics given by mouth or through a drip)
  • People with known mental health conditions or substance use disorders that could make it difficult to follow the trial requirements
  • People who are pregnant, breastfeeding, or planning to have children during the trial period or within 6 months after the last dose of treatment
  • People who are currently receiving other cancer treatments (such as chemotherapy, biological therapies, or other immunotherapy not part of this trial), or who are taking part in another clinical trial involving a different experimental medicine
  • People who have received certain live vaccines (such as measles, mumps, chickenpox, yellow fever, or others) within 30 days before starting the trial or during participation (note: standard injected flu vaccines are generally permitted, but nasal spray flu vaccines are not — confirm with trial site)

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 6 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: Jianjun Zhang, M.D. Anderson Cancer Center

Phone: 713-792-6363

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
Registry
ClinicalTrials.gov
Start date
20 July 2021
Est. completion
31 December 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Regression of indeterminate pulmonary nodules (IPNs)

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: 6 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