Phase 2 Lung Cancer Trial, Recruiting

Written by an AI model from the 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 who are willing and able to sign a consent form and take part in all study activities for the full duration of the trial.
• Adults aged 18 years or older.
• People who have been diagnosed with stage IV non-small cell lung cancer (an advanced form of lung cancer), confirmed by a laboratory test on a tissue or cell sample.
• People whose cancer does not have certain specific gene changes (such as EGFR, ALK, ROS1, BRAF, RET, NTRK, or MET mutations) for which the FDA has already approved a targeted treatment as a first-line therapy.
• People who have not yet received any systemic (whole-body) cancer treatment for advanced or metastatic disease. People who received one cycle of chemotherapy while waiting for genetic and protein test results may be considered after discussion with the trial's medical monitor.
• People whose cancer can be measured on scans, following standard measurement guidelines (RECIST 1.1).
• People with a life expectancy of at least 3 months.
• People who are reasonably active and able to care for themselves, rated 0, 1, or 2 on a standard scale used to measure how cancer affects daily functioning (ECOG Performance Status).
• People who have provided a tumour tissue sample (either a fresh sample or a stored one) from an area that was not previously treated with radiation, and whose tumour has been tested and found to have very low or no levels of a protein called PD-L1 (less than 1% or negative).
• People whose blood has been tested for circulating tumour DNA (genetic material shed by the tumour into the bloodstream) and the result was detected, present, or positive.
• People who have cancer that has spread to the brain (CNS metastases), provided all brain metastases have been treated, have been stable for at least 2 weeks after treatment, the person's neurological condition has returned to their normal baseline or remained stable for at least 2 weeks, and any steroid medication used for the brain metastases is at a low dose (no more than 10 mg per day of prednisone or equivalent) and has been stable for at least 2 weeks before joining the trial.
• People whose liver, kidneys, blood, and other organs are functioning well enough to safely receive the standard treatment regimens used in this trial, as determined by the treating doctor.
• Women of childbearing potential who have a negative pregnancy test (urine and/or blood) within 72 hours before starting the study medication, and who are willing to use reliable contraception throughout the study and for 120 days after the last dose of study medication, or 180 days after the last dose of chemotherapy. Abstinence is acceptable if that is the person's usual and preferred approach.
• Men of reproductive potential who are willing to use condoms or another reliable method of contraception with their partner. Abstinence is acceptable if that is the person's usual and preferred approach.

Who may not be able to join:

• People who are currently taking part in another clinical trial or who have received an experimental treatment within the past 4 weeks.
• People who have received a live-virus vaccine within 30 days before the planned start of treatment. (Seasonal flu vaccines that do not contain a live virus are permitted.)
• People who currently have active diverticulitis (inflammation of pouches in the bowel), an abscess inside the abdomen, a bowel blockage, or cancer that has spread widely throughout the lining of the abdomen.
• People who have previously been treated with, or have had an allergic or severe reaction to, certain types of immune checkpoint or T-cell targeting drugs (including anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 therapies).
• People with a known allergy or sensitivity to cisplatin, carboplatin, paclitaxel, or pemetrexed (chemotherapy drugs used in this trial).
• People whose cancer has spread to the membranes surrounding the brain and spinal cord (carcinomatous meningitis).
• People with an active or suspected autoimmune disease (where the immune system attacks the body). Some exceptions apply, including well-controlled type 1 diabetes, stable vitiligo (skin pigment loss), stable low thyroid function due to a previous autoimmune condition that is managed with hormone replacement, mild psoriasis not requiring systemic treatment, or other autoimmune conditions not expected to return without a trigger.
• People who have taken steroid tablets or other immune-suppressing medications by mouth or injection in the 14 days before joining the trial. Some exceptions apply, such as steroid creams, inhalers, nasal sprays, or eye drops, or very low-dose oral steroids (no more than 10 mg per day of prednisone or equivalent).
• People who have a history of, or currently have symptoms of, a lung condition called interstitial lung disease (ILD) or pneumonitis (inflammation of lung tissue).
• People who test positive for HIV, hepatitis B, or hepatitis C, unless the condition is very well controlled, poses no increased risk of immune suppression, and there are no potential interactions with the study medications (confirm with trial site).
• People who have had another cancer in the past, unless it was a skin cancer (basal cell or squamous cell), a cervical or breast cancer that had not spread beyond its original site (carcinoma in situ), or another localised cancer that was treated and fully resolved — and the person has been in complete remission for more than two years before joining the trial.

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