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 have been newly diagnosed with Stage IV non-small cell lung cancer (a type of lung cancer) that has not yet been treated
• People whose tumour tests positive for a protein called PD-L1 (at 1% or more), measured using a specific approved test
• People who have had a specific blood-based cancer DNA test called Guardant360 CDx completed before joining the trial
• People who are willing to have repeated blood-based cancer DNA tests throughout the trial as required
• People who are 18 years of age or older
• People whose doctors estimate they have a life expectancy of at least 12 weeks
• People who have at least one measurable area of cancer (that has not been treated with radiation) that can be tracked using standard medical imaging guidelines
• People who have finished any prior palliative radiation therapy (to areas outside the brain) at least 2 weeks before joining
• People who are reasonably physically functional, as measured by a standard medical scoring system (ECOG score of 2 or less — meaning someone who is up and about for at least half of waking hours)
• People whose blood, liver, and kidney test results fall within acceptable ranges, including: sufficient haemoglobin, platelet count, liver enzyme levels, bilirubin, white blood cell count, and kidney function
• People of childbearing potential who are willing to use highly effective contraception, have a negative pregnancy test, and are not breastfeeding — or who have documented evidence that they cannot become pregnant
• Male participants who are willing to use barrier contraception

Who may not be able to join:

• People under the age of 18
• People who are unable to give informed consent themselves, and who do not have an authorised representative who can do so
• People whose cancer is driven by specific known genetic changes (EGFR, ALK, ROS1, MET, or RET) for which approved first-line targeted treatments already exist — all participants must have tissue or blood testing done to check for these changes
• People whose baseline Guardant360 CDx blood test shows no detectable cancer DNA, or shows very low levels (VAF of 0.3% or less)
• People who have brain metastases (cancer that has spread to the brain) that have not yet been treated
• People who have brain metastases that have been treated but have not neurologically returned to baseline for at least 2 weeks before joining, or who are still on more than 10 mg per day of prednisone (or equivalent steroid) and have not been on a stable or reducing dose for at least 2 weeks
• People who have cancer that has spread to the membranes surrounding the brain and spinal cord (carcinomatous meningitis)
• People who have not yet fully recovered from major surgery or a serious injury within the past 14 days
• People who have had a previous different cancer, unless it was fully cleared (complete remission) at least 2 years ago and no further treatment is needed or expected — some exceptions apply for certain early-stage or skin cancers
• People who currently have another active cancer requiring treatment at the same time
• People who have an active, known, or suspected autoimmune disease — some exceptions apply for conditions such as type 1 diabetes, hypothyroidism, or certain skin conditions that do not require systemic treatment
• People who are currently taking high-dose corticosteroids (more than 10 mg per day of prednisone or equivalent) or other immune-suppressing medications within 14 days of joining — some exceptions apply for inhaled, topical, or adrenal replacement steroids
• People who have symptomatic lung scarring or inflammation (interstitial lung disease) that could interfere with detecting or managing potential side effects of the study drug
• People with significant uncontrolled heart or cardiovascular problems, including: uncontrolled high blood pressure, active coronary artery disease or newly diagnosed chest pain within the past 3 months, a heart attack in the past 6 months, a history of a specific inherited heart rhythm disorder (long QT syndrome), a history of serious irregular heart rhythms, uncontrolled heart failure (classified as severe), or a current or past diagnosis of heart muscle inflammation (myocarditis)
• People with a known medical condition that, in the investigator's opinion, would increase the risks of being in the trial or make it harder to interpret safety results
• People who test positive for active or chronic hepatitis B or hepatitis C infection
• People who have moderate nerve damage in their hands or feet (Grade 2 peripheral neuropathy)
• People with a life expectancy of less than 12 weeks

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