Phase 2 Lung Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 19 years or older
• People who have been diagnosed with non-small cell lung cancer (a type of lung cancer) confirmed by a laboratory test, where the tumour tests positive for a protein called PD-L1 at a level of at least 1%
• People whose cancer has spread to other parts of the body, or whose cancer cannot be treated with the aim of a cure
• People who have not previously received treatment for their advanced or metastatic lung cancer. Prior treatment for early-stage disease is acceptable if it was completed at least six months ago and did not include immunotherapy
• People whose general health and ability to carry out daily activities meets a certain level, assessed using a standard medical scale (confirm with trial site)
• People whose cancer can be measured using standard imaging criteria
• People whose blood counts, kidney function, and liver function meet minimum required levels (confirm with trial site)
• Women who could become pregnant must have a negative pregnancy test within 7 days of starting treatment, and must agree to use effective contraception during treatment and for 90 days after treatment ends
• Men must agree to use effective contraception during the trial and for 90 days after treatment ends
• People who are able to understand and sign a consent form agreeing to take part

Who may not be able to join:

• People who have received any systemic (whole-body) treatments, including experimental drugs, within the last 28 days
• People with a known allergy or sensitivity to any ingredients in the study drugs OT101 or pembrolizumab
• People who have received radiotherapy within 14 days before starting the study treatment (palliative radiation during the study may be allowed with a one-week gap — confirm with trial site)
• Women who are pregnant or breastfeeding
• People who have a history of autoimmune disease (where the immune system attacks the body) that required treatment with steroids or immune-suppressing drugs within the past 2 years. Some exceptions apply, such as thyroid hormone replacement, insulin for type 1 diabetes, or steroids for certain hormone deficiencies
• People with serious uncontrolled health conditions that the study doctor believes could interfere with participation
• People with a known active second cancer that currently requires treatment, with some exceptions such as certain skin cancers, early-stage bladder or cervical changes, or prostate cancer managed with hormone therapy alone
• People with an immune deficiency diagnosis, or those taking ongoing steroid medication at doses higher than the equivalent of 10 mg of prednisone daily
• People with brain metastases (cancer that has spread to the brain) that are causing symptoms. People with brain metastases that are not causing symptoms, or who have already been treated for brain metastases and are no longer on steroids, may be eligible (confirm with trial site)
• People with known psychiatric conditions or substance use issues that could interfere with following the study requirements
• People who are unable to cooperate with or follow the requirements of the study

Important: Always verify eligibility with the trial site directly before applying.