Phase 2 Lung Cancer Trial, Recruiting NCT06745882 Sponsor: H. Lee Moffitt Cancer Center and Research Institute Condition: Lung Cancer
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Phase 2 Lung Cancer Trial, Recruiting

NCT06745882
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 sign a written consent form agreeing to take part.
  • People who are 18 years of age or older at the time of signing the consent form.
  • People who identify as Black or African American.
  • People whose overall health and ability to carry out daily activities falls within an acceptable range (a medical team will assess this using a standard scale called ECOG, scored 0–2).
  • People who have been diagnosed with advanced or metastatic non-small cell lung cancer (a type of lung cancer that has spread), confirmed through a tissue or cell sample.
  • People who have not yet received any treatment for their advanced, metastatic, or returned lung cancer.
  • People whose tumour does not have certain known genetic changes called EGFR, ALK, or ROS1 mutations — this can be checked through a blood test.
  • People who previously received certain chemotherapy or immunotherapy for early-stage or locally advanced lung cancer, as long as their cancer came back at least 6 months after finishing that earlier treatment.
  • People whose doctor is planning to offer them a first-line (first course of) treatment for advanced or metastatic disease.
  • People who have had their tumour tested for a protein called PDL1.
  • People who had side effects from previous cancer treatments, where those side effects have mostly resolved to a mild or baseline level (some exceptions apply for hormone-related or nerve-related side effects — confirm with trial site).
  • People whose liver, kidneys, and other organs are functioning at an adequate level.
  • Women who could become pregnant must have a negative pregnancy test (urine or blood) within 72 hours before starting the study medication.
  • Women who could become pregnant must agree to use 2 forms of birth control, be surgically sterile, or avoid heterosexual activity for the duration of the study and for a set period after the last dose (the length of time depends on which treatment is received — confirm with trial site).
  • Men must agree to use a barrier method of contraception (such as a condom) from the first dose of study treatment through 180 days after the last dose.

Who may not be able to join:

  • People whose doctor does not plan to offer, or who are not considered suitable to receive, pembrolizumab (with or without chemotherapy) as part of their standard care.
  • People who have previously received an organ or tissue transplant from another person.
  • (For certain parts of the trial only) People who have already received chemotherapy or immunotherapy for advanced or metastatic lung cancer.
  • (For certain parts of the trial only) People who have a condition that weakens the immune system, or who are currently taking high-dose steroid or other immune-suppressing medications (some lower-dose or short-course exceptions may apply — confirm with trial site).
  • (For certain parts of the trial only) People who have an active autoimmune disease (where the immune system attacks the body) that has needed treatment with certain medications in the past 2 years (some exceptions apply for milder conditions — confirm with trial site).
  • (For certain parts of the trial only) People who currently have an active infection that requires medication.
  • (For certain parts of the trial only) People who have received a live vaccine within 30 days before the planned start of the study treatment.
  • People who have received another experimental treatment or used an experimental medical device within 3 weeks before starting the study.
  • People who have a history of, or currently have, lung inflammation (pneumonitis or interstitial lung disease) that required steroid treatment.
  • People who have untreated cancer that has spread to the brain or the lining around the brain. People with previously treated and stable brain metastases may still be considered — confirm with trial site.
  • People who have had a severe allergic reaction to pembrolizumab or any of its ingredients, or who are known to be sensitive to certain chemotherapy drugs used in the trial (carboplatin, cisplatin, taxane, or pemetrexed).

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 28 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: Jhanelle Gray, MD, Moffitt Cancer Center

Phone: 813-745-0287

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
13 June 2025
Est. completion
1 January 2030

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Cohort 1: Real World Overall Survival (rwOS); Cohort 2 Arm A: Progression Free Survival (PFS); Cohort 2 Arm B: Progression Free Survival (PFS)

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: 28 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