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 aged 18 or older (or the legal age of consent in the country where the trial is taking place) at the time of signing the consent form.
• People diagnosed with a specific type of lung cancer called non-small cell lung cancer (NSCLC) — including nonsquamous, squamous, or adenosquamous types — that is at an advanced stage (Stage III) and cannot be removed by surgery.
• People whose lung cancer came back after earlier surgery (from Stage I, II, or III) or where surgery did not fully remove the cancer, as long as no chemotherapy, radiation, immunotherapy, targeted therapy, or experimental treatments have been given since.
• People whose tumor test results confirm one of two specific gene changes (called EGFR mutations — either Ex19del or L858R), which may indicate the cancer could respond to a type of targeted treatment called an EGFR inhibitor.
• People with a general health score (called WHO performance status) of 0, 1, or 2, with no decline in health in the two weeks before the trial starts.
• People who a doctor has assessed as suitable for radiation therapy and who are planning to receive it.
• People who have declined chemotherapy or who a doctor has assessed as not suitable for chemotherapy.
• People with a life expectancy of more than 12 weeks at the start of the trial.
• People with at least one measurable tumor lesion of 10 mm or larger (or, for lymph nodes, 15 mm or larger) that can be tracked over time using CT or MRI scans.
• People who are able to understand and agree to the trial's requirements by signing a consent form.

Who may not be able to join:

• People whose lung cancer includes small cell components or a mix of small cell and non-small cell types.
• People with a past or current history of a lung condition called interstitial lung disease (ILD), lung inflammation from radiation (pneumonitis) that needed steroid treatment, or any currently active ILD.
• People with serious uncontrolled health conditions such as uncontrolled high blood pressure, active bleeding disorders, or active infections that, in the doctor's opinion, make participation unsafe.
• People with ongoing severe nausea and vomiting, chronic digestive conditions, difficulty swallowing tablets, or a history of significant bowel surgery that could prevent the study drug (osimertinib) from being properly absorbed.
• People with a history of another cancer, unless it was treated with the aim of cure, has shown no signs of returning for at least 2 years before the trial starts, and carries a low risk of coming back. Some exceptions apply (such as certain skin cancers or in-situ cancers treated successfully), but people who received radiation therapy that overlaps with areas treated for a previous cancer (for example, cured breast cancer) may not be eligible.
• People with certain heart rhythm abnormalities, specifically a heart electrical reading (QTc interval) averaging more than 470 milliseconds across three measurements.
• People with poor bone marrow function or inadequate organ function (confirm with trial site for specific thresholds).
• People who still have side effects from a previous treatment that are rated above a mild level (Grade 1), with some exceptions such as hair loss or certain nerve-related side effects from previous platinum chemotherapy.
• People who have previously received chemotherapy, radiation, immunotherapy, targeted therapy, or experimental treatments specifically for locally advanced, unresectable Stage III NSCLC (prior surgery for earlier-stage disease without follow-up treatment is generally permitted).
• People who have previously been treated with EGFR-targeted therapy (a type of targeted drug that works on the same pathway as the study drug).
• People who have had a major surgical procedure or significant injury within 4 weeks before the trial starts, or who are expected to need major surgery during the trial.
• People who have participated in another clinical trial involving an experimental treatment or device within the past 4 weeks.
• People with a known allergy or sensitivity to osimertinib or to drugs with a similar chemical makeup.
• People with a known allergy or sensitivity to any component of the radiation therapy used in the trial.
• People who are involved in planning or running this study (including staff at the trial site or the company running the trial).
• People who, in the trial doctor's judgment, are unlikely to follow the trial's procedures and requirements.
• People who have already been enrolled in this trial previously (people who were previously screened but did not qualify may be re-screened).
• People who are currently pregnant or breastfeeding.
• People who are breastfeeding or plan to breastfeed during the trial or within 6 weeks after the last dose of the study treatment.

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