Phase 1 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 non-small cell lung cancer (NSCLC) confirmed by a tissue or cell sample test.
• People with stage IIIA, IIIB, or IIIC NSCLC where the cancer cannot be removed by surgery, as decided by a medical team (or where the person has chosen not to have surgery).
• People who have had the required cancer staging scans (a PET/CT scan and a brain scan) completed within the 60 days before starting combined chemotherapy and radiation treatment.
• People who are able to use the NovoTTF-200T device (a wearable medical device) on their own or with help from a carer.
• People who are well enough to receive standard combined chemotherapy and radiation treatment, as judged by their treating doctor.
• People whose cancer can be measured on a CT scan according to standard measurement guidelines (RECIST 1.1).
• People with a good general health and activity level, rated 0 or 1 on the ECOG scale (meaning fully active or restricted in physically demanding activity but able to carry out light work).
• People whose blood counts, liver function, and kidney function meet the minimum levels required by the trial.
• People who are post-menopausal, have had surgical sterilisation, or have a negative pregnancy test (for those who could become pregnant).
• People who are able and willing to use highly effective contraception if there is any possibility of pregnancy (for the person themselves or their sexual partner).
• People who are able to understand the study information and are willing to sign a consent form.
• To move into the second phase of the trial (consolidation immunotherapy), people must have completed the first phase, had a follow-up CT scan, and still meet the health and organ function requirements listed above, with any side effects from prior treatment having settled to a mild or baseline level.
• Lung inflammation (pneumonitis) from prior radiation must have resolved to less than grade 1 before entering the second phase (confirm with trial site).

Who may not be able to join:

• People who have previously had radiation to the chest or breast area.
• People who have previously used the TTFields device.
• People who have previously received immunotherapy or radiation therapy for NSCLC.
• People with a known skin sensitivity or allergy to skin adhesives or hydrogel (the materials used with the device).
• People with a known sensitivity to radiation caused by a genetic condition, connective tissue disease, or any other reason.
• People currently taking part in another clinical trial involving an investigational treatment.
• People who have had major surgery within 4 weeks before starting the study, or who have not fully recovered from major surgery.
• People diagnosed with another cancer within the past 2 years, unless it has been successfully treated with no signs of return and will not need treatment during the study (some low-risk skin cancers, early-stage cancers, and low-grade prostate cancer may be exceptions — confirm with trial site).
• People with serious uncontrolled heart conditions, including severe heart failure, unstable chest pain, dangerous heart rhythm problems, a heart pumping function below 50%, or uncontrolled high blood pressure.
• People who have had a stroke, heart attack, blood clot (such as a deep vein thrombosis or pulmonary embolism) within the 3 months before starting the trial.
• People with a specific type of abnormal heart rhythm measurement on an ECG (QTcF above 500 ms) or a known inherited heart condition called long QT syndrome.
• People who have an implanted pacemaker, defibrillator, or other electrical medical device in their body.
• People with a known HIV infection where the virus is still detectable within 6 months before starting treatment (people with HIV who are on effective treatment and have an undetectable viral load may still be considered — confirm with trial site).
• People with active tuberculosis, active hepatitis B, or active hepatitis C infection (some people with past resolved infections may still be considered — confirm with trial site).
• People with medical, mental health, or cognitive conditions that would prevent them from fully understanding or following the study requirements.
• People who have previously had a stem cell transplant or solid organ transplant (such as a kidney or liver transplant).
• People with active or previously documented autoimmune or inflammatory conditions such as lupus, Crohn's disease, rheumatoid arthritis, or similar disorders (some exceptions may apply, such as controlled thyroid conditions on hormone replacement or vitiligo — confirm with trial site).
• People who have taken immune-suppressing medications in the 14 days before starting the trial (certain low-dose or locally applied steroids may be permitted — confirm with trial site).
• People taking certain prohibited medications who have not had an adequate washout period before starting the trial (confirm with trial site).
• People who have a history of fluid build-up around the lungs (exudative pleural effusion), regardless of test results.
• People with nerve damage (peripheral neuropathy) greater than grade 1 who are receiving a specific chemotherapy combination (carboplatin and paclitaxel) with radiation.
• People whose cancer has progressed after completing combined chemotherapy and radiation treatment are not eligible to enter the second phase of the trial.

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