Phase 1 Lung Cancer Trial, Recruiting NCT04297605 Sponsor: University of Rochester Condition: Lung Cancer
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Phase 1 Lung Cancer Trial, Recruiting

NCT04297605
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:

  • People who were over 18 years old at the time of their lung cancer diagnosis.
  • People who have been diagnosed with non-small cell lung cancer, confirmed through a tissue sample test.
  • People whose physical functioning has been assessed by their doctor as limited — able to care for themselves but unable to do any work (this is called ECOG Performance Status 2; confirm with trial site).
  • People whose cancer is at an advanced stage (Stage IIIc or Stage IV).
  • People with Stage IIIc disease where standard chemotherapy combined with radiation is either not suitable for them or has been declined by the patient.
  • People with Stage IV disease where standard platinum-based chemotherapy is considered not appropriate or unsafe by their treating doctor, or has been declined by the patient.
  • People whose recent blood test results meet certain minimum levels for white blood cells, platelets, kidney function (if a specific drug called pemetrexed is being offered), and liver enzymes (confirm with trial site for specific values).
  • People who have small brain metastases (cancer that has spread to the brain) that are not causing symptoms.
  • Women who could become pregnant must have a negative pregnancy test and must agree to use effective contraception during the trial and for 120 days after the last dose of the study drug.
  • Women who are not able to become pregnant due to reasons such as being postmenopausal for over 2 years, having had certain surgical procedures, or meeting other defined criteria (confirm with trial site).
  • People who have read, or had explained to them, the study's purpose and have signed a consent form before joining. Non-English speakers may be consented according to the institution's own procedures.

Who may not be able to join:

  • People with a history of autoimmune conditions, with the exception of certain conditions including alopecia (hair loss), vitiligo, rheumatoid arthritis, psoriasis or psoriatic arthritis, and Hashimoto's thyroiditis, which are permitted.
  • People currently taking immunosuppressive medications, including steroids at a dose higher than the equivalent of 10 mg of prednisone daily (short courses of steroids that are stopped before treatment begins may be acceptable).
  • People with significant heart, liver, or kidney disease that their treating doctor considers would make chemotherapy or immunotherapy unsafe for them.
  • People who are currently participating in another clinical trial involving an experimental treatment.
  • Women who are currently pregnant or breastfeeding.
  • People with any other medical or psychiatric condition that their doctor considers makes participation in this trial unsuitable.
  • People who have brain metastases that are causing symptoms and have not yet been treated. People whose brain metastases have been treated with radiation may be considered if steroid doses have been reduced below the equivalent of 10 mg of prednisone daily.
  • People who have an active infection currently being treated with intravenous (IV) antibiotics.

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 22 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: Megan Baumgart, University of Rochester

Phone: 585-275-4401

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
15 May 2020
Est. completion
30 November 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Number of participants with Adverse Events as a Measure of Safety and Tolerability

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: 22 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