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 aged 18 or older
• People who have signed informed consent (or whose legal representative has done so)
• People whose ability to carry out daily activities is reasonably maintained, as measured by a standard oncology performance scale (ECOG score of 2 or less)
• People with a confirmed diagnosis of advanced non-small cell lung cancer (a type of lung cancer)
• People whose lung cancer has a specific genetic change (mutation) in the EGFR gene — either the Ex19del or L858R type — which may also appear alongside other EGFR mutations including one called T790M
• People whose cancer has gotten worse (progressed) while being treated with osimertinib as a first-line single treatment, and who had a period of stable disease lasting more than 6 months before that progression, confirmed by PET or CT scan
• People whose cancer progression is limited to 1 to 5 sites outside the brain, with no more than 3 individual spots in any one organ (confirm with trial site for specific details about how sites are counted)
• People who have had previous metastases treated with targeted local therapies (such as ablation) before their current treatment may still be eligible
• People with brain metastases may be eligible, provided those brain metastases have already been treated, are not causing symptoms, have not required steroid medication for at least 1 week before starting the study drug, and radiation to the brain was completed at least 2 weeks before starting the study drug (brain metastases would not count toward the 1–5 progression sites)
• People whose progressing tumour spots are suitable for a type of radiation treatment called SBRT, as determined by a radiation oncologist, with a minimum radiation dose of 30 Gy in 5 sessions being deliverable
• People who have at least one tumour spot (either in the lung or bone, measuring 2 cm or larger) suitable for a specific guided radiation technique called BgRT, also at a minimum dose of 30 Gy in 5 sessions
• People who have not received any other systemic (whole-body) treatment for their advanced lung cancer aside from osimertinib
• Women who could become pregnant must have a negative pregnancy test before joining
• People of childbearing potential who agree to use effective contraception or abstain from heterosexual activity during the study and for at least 4 months after the last dose of study treatment
• People who are able to swallow and keep down oral medications
• People with a life expectancy of at least 6 months

Who may not be able to join:

• People who have received chemotherapy, radiation, biological therapy, or immunotherapy within 21 days before starting the study (6 weeks for certain specific chemotherapy drugs); exceptions include brain radiation (2-week gap) and osimertinib
• People who have taken strong medications that significantly affect how the body processes certain drugs (strong CYP3A4 inducers or inhibitors) within 14 days before starting the study
• People taking certain heart rhythm medications (Class 1A or Class III antiarrhythmic agents) within 14 days before starting the study
• People taking medications known to affect the heart's electrical activity in a specific way (QT interval prolongation)
• People with a known allergy to drugs that are chemically similar to the study drug
• People with serious uncontrolled health conditions
• People with an active infection (bacterial, viral, or fungal) currently requiring antibiotic or antifungal treatment
• People with a known history of HIV, hepatitis B, or hepatitis C infection
• People with a history of another cancer, unless it was cervical carcinoma in situ or a non-melanoma skin cancer, or unless the prior cancer was fully treated 5 or more years ago with no signs of return; certain low-grade prostate cancers diagnosed less than 5 years ago may still be eligible, and other low-risk cancers may be allowed with the lead investigator's approval (confirm with trial site)
• People who are pregnant or breastfeeding
• People with conditions that affect the body's ability to absorb medications properly
• People with a diagnosed condition called congenital long QT syndrome (an inherited heart rhythm disorder)
• People with serious heart disease, including severe heart failure (New York Heart Association Class III or IV), a heart attack within the past 6 months, an unstable heart rhythm, or signs of reduced blood flow to the heart on an ECG
• People with active or historical lung inflammation (interstitial lung disease or pneumonitis) that has required steroid treatment
• People with spreading cancer to the lining of the brain or spinal cord (leptomeningeal carcinomatosis), unless they have previously treated, symptom-free brain metastases meeting the criteria described above
• People who, in the investigator's judgement, may not be able to follow all study requirements

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