Phase 2 Lung Cancer Trial, Recruiting NCT05589818 Sponsor: Icahn School of Medicine at Mount Sinai Condition: Lung Cancer
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Phase 2 Lung Cancer Trial, Recruiting

NCT05589818
Recruiting Phase 2

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not 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 may be able to join

  • Adults aged 18 or older who have been diagnosed with non-small cell lung cancer (NSCLC) that has spread locally and cannot be treated with surgery or a combination of chemotherapy and radiation, or NSCLC that has spread to other parts of the body
  • People who have not yet received any systemic (whole-body) treatment for their cancer that has spread
  • People who have never received a type of immunotherapy drug that targets PD-1 or PD-L1
  • People whose physical functioning falls within a specific range on a medical scale called ECOG, rated 2 or 3 (meaning some limitations in daily activity but still able to care for oneself) — both at the time of joining and on the first day of treatment
  • People whose cancer does not have certain specific gene changes (in ALK, ROS1, EGFR, BRAF, NTRK, RET, MET, or similar genes) for which the FDA has already approved a targeted treatment as a first-line therapy
  • People who have had brain tumours treated previously, as long as there is no sign of those tumours growing for at least 4 weeks after that brain-directed treatment, confirmed by brain scans
  • People who have new or growing brain tumours, where the treating doctor determines that immediate brain-directed treatment is not needed during the first cycle of this trial
  • People living with HIV who are on effective anti-HIV medication and have had an undetectable level of the virus in the past 6 months
  • People whose blood counts and organ function meet the required levels, including healthy enough levels for white blood cells, platelets, liver function, and kidney function (confirm with trial site for specific numbers)
  • Women who could become pregnant must have a negative pregnancy test within 3 days before starting treatment
  • People who are willing and able to sign a consent form, take the study medication, complete study questionnaires, and follow all study procedures for the full duration of the trial
  • Women who could become pregnant must agree to use highly effective contraception during the study and for at least 4 months after the last dose
  • Men who could father a child must agree to use condoms or other effective contraception with female partners who could become pregnant

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People with autoimmune conditions that require more than 10mg of prednisone (or a similar steroid) daily, or who need other medicines that suppress the immune system
  • People who are currently taking part in another clinical trial involving an investigational treatment
  • People with serious uncontrolled health conditions, such as an active infection, heart failure, unstable chest pain, irregular heartbeat, or mental health or personal circumstances that would make it difficult to follow the study requirements
  • People with a known spread of cancer into the fluid and lining around the brain and spinal cord (leptomeningeal disease) that requires immediate treatment
  • People who are pregnant or currently 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 30 July 2026

Contact this trial

Principal Investigator: Deborah Doroshow, MD, PhD, Icahn School of Medicine at Mount Sinai

Phone: 212-241-5615

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
5 December 2023
Est. completion
1 May 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in EORTC QLQ-C30 Quality of Life score

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: 30 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