Phase 1 Lung Cancer Trial, Recruiting NCT05777603 Sponsor: National Cancer Institute (NCI) Condition: Lung Cancer
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Phase 1 Lung Cancer Trial, Recruiting

NCT05777603
Recruiting Phase 1

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:

  • A confirmed diagnosis of non-small cell lung cancer (NSCLC), verified by a tissue or cell sample from a pathology lab.
  • The cancer must be measurable on scans and not able to be removed with surgery.
  • Test results showing a PD-L1 score of 1% or higher at any point since diagnosis, using an FDA-approved testing device.
  • The cancer has gotten worse after receiving a standard first-line treatment approved by the FDA for NSCLC.
  • People aged 18 or older.
  • A general health/activity level score of 2 or less on the ECOG scale, meaning the person is able to care for themselves and is up and about more than half of waking hours (confirm with trial site).
  • Blood and organ function within acceptable ranges, including healthy enough levels of white blood cells, platelets, liver function, and kidney function.
  • People who have had brain metastases that were already treated may be eligible, as long as follow-up brain scans show the cancer has not grown back there.
  • People with new or growing brain metastases may be eligible if immediate brain-specific treatment is not urgently needed right away or during the first treatment cycle.
  • People living with HIV who are on effective HIV medication and have had an undetectable viral load in the 6 months before starting the study.
  • People with a chronic hepatitis B infection whose virus levels are undetectable while on appropriate treatment.
  • People with a history of hepatitis C who have been successfully treated and cured, or who are currently being treated and have an undetectable hepatitis C viral load.
  • People who are able to become pregnant must agree to use effective contraception from the start of the study until 4 months after finishing treatment (abstinence is also accepted if that is the person's usual lifestyle).
  • People who are currently breastfeeding must be willing to stop breastfeeding for the full duration of the study treatment.
  • Willingness and ability to understand and sign a written consent form to participate in the study.

Who may not be able to join:

  • People who are currently taking part in another clinical trial involving an experimental treatment.
  • People with an ongoing active Epstein-Barr virus or cytomegalovirus infection.
  • People with a history of serious allergic reactions to medicines that are chemically or biologically similar to pembrolizumab, aztreonam, vancomycin, or albuterol.
  • People who are pregnant at the time of screening.
  • People whose lung function is significantly reduced — specifically, where a breathing test result called FEV1 is below 25% — due to the requirement to receive one of the study drugs as an inhaled mist.
  • People with a history of severe immune-related side effects from previous treatment, including any nerve or heart-related immune reactions at any severity level, any grade 3 or 4 immune reaction (except hormone-related ones that are fully managed with supplementation), or any immune-related lung inflammation.
  • People with ongoing, uncontrolled health conditions that would make it difficult to follow the study requirements.

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 13 July 2026
Phase 1: approximately ~10% 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: Chen Zhao, M.D., National Cancer Institute (NCI)

Phone: (240) 858-3157

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 1
Registry
ClinicalTrials.gov
Start date
18 April 2024
Est. completion
1 June 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Dose limiting toxicities (DLTs) - type and grade

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: 13 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