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 who have been diagnosed with metastatic non-small cell lung cancer (a type of lung cancer that has spread), either newly diagnosed without prior treatment or with cancer that has come back.
• People who have stored biopsy tissue available, or who are willing to have a new biopsy taken before the trial starts, so that certain tumour markers can be tested (test results are not required before joining).
• People whose cancer can be measured on scans according to a standard set of measurement rules (called RECIST 1.1).
• People who are at least 18 years old.
• People who are generally able to carry out everyday activities with no or minimal limitation (confirm with trial site what this means for individual circumstances).
• People whose blood counts and organ function meet specific minimum levels — including white blood cells, platelets, haemoglobin, liver enzymes, bilirubin, kidney function, and blood clotting measures (the trial site will check these through blood tests).
• People who have cancer that has spread to the brain may be eligible, provided it has already been treated with surgery or radiation, there has been at least a 2-week recovery period, the person is neurologically stable, and they are not taking more than a low dose of a steroid medication (such as 10 mg of prednisone per day or equivalent).
• People who are willing and able to use highly effective contraception from the time of signing the consent form until 6 months after the last dose of study treatment — this applies to people who could become pregnant and to people who could father a child.
• People who are able to understand and sign a written consent form, or who have a legally authorised representative who can do so on their behalf.

Who may not be able to join:

• People whose lung cancer is a mixed type that includes small cell lung cancer.
• People whose tumour has certain specific genetic changes, including mutations or fusions in EGFR (classic), HER2, ALK, ROS1, RET, NTRK, MET Exon 14, or BRAF V600E (the trial site will check for these through tumour testing).
• People who have received a live vaccine within 28 days before the trial starts.
• People who received chemotherapy as part of post-surgery treatment or alongside radiation therapy for locally advanced disease within the past 12 months (those whose last treatment was 12 or more months ago may still be eligible).
• People who have had radiation therapy within 14 days before the trial starts.
• People who have had major surgery within 14 days before the trial starts.
• People with certain underlying health conditions that the trial doctor considers would make the study treatment unsafe — including a history of a type of lung inflammation (interstitial lung disease or non-infectious pneumonitis), a serious active infection requiring intravenous treatment within 14 days before the trial starts, significant heart or blood vessel disease, a previous solid organ transplant, or conditions that could make it difficult to assess side effects.
• People who need to take high doses of steroid medications (more than 10 mg per day of prednisone or equivalent) or other immune-suppressing medications on an ongoing basis (absorbable topical steroids applied to the skin are not excluded).
• People living with HIV who are not on effective HIV treatment with an undetectable viral load for at least the past 6 months (those with HIV who do have an undetectable viral load on treatment may be eligible).
• People with chronic hepatitis B infection where the virus is still detectable, even on suppressive treatment (those with hepatitis B and an undetectable viral load on suppressive treatment may be eligible).
• People with a history of hepatitis C infection that has not been successfully treated and cleared, or where the virus is still detectable (those who have been successfully treated and cured, or who are on treatment with an undetectable viral load, may be eligible).
• People with known psychiatric conditions or substance use disorders that would make it difficult to participate in or follow the requirements of the trial.
• People who have an active autoimmune disease, or a history of autoimmune disease that required systemic treatment (such as immune-modifying drugs, steroids, or immunosuppressants) in the past 2 years — with some exceptions, including vitiligo, childhood asthma or allergies that have fully resolved, hormone replacement therapies, and people with asthma who only use inhalers or occasional local steroid injections.
• People who have or have had another cancer whose progression could affect how the safety or effectiveness of this trial can be assessed (confirm with trial site for individual circumstances).
• People who have taken another experimental drug (one not yet approved for any use) within 28 days or 5 half-lives before the trial starts, whichever is the longer period.
• People who have had a significant allergic reaction to drugs with a similar composition to those used in this trial, or who have a known sensitivity to certain protein-based medicines or ingredients in the trial formulations.
• People who are pregnant or breastfeeding. People who could become pregnant must have a negative pregnancy test within 7 days of starting the trial.

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