Phase 3 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:

• Adults aged 18 to 74 years (inclusive).
• People who have been diagnosed with a specific type of lung cancer called non-small cell lung cancer (NSCLC), confirmed by a tissue test, with a non-squamous cell type.
• People who have had brain and bone scans (MRI or CT) before surgery or joining the trial, to confirm the cancer has not spread.
• People who have had complete surgical removal of the cancer, where all edges of the removed tissue were clear of cancer and the lymph nodes in the chest were also fully removed and clear.
• People whose cancer has been confirmed after surgery to be at stage II, IIIA, or a specific type of stage IIIB (T3N2M0).
• People whose cancer has a specific gene change (mutation) in a gene called EGFR — specifically the Ex19del or L858R mutation — confirmed by a central laboratory.
• People who have fully recovered from surgery and any follow-up treatment before joining the trial.
• People who are in good general health with minimal or no limitations on daily activity (confirmed by a standard health scale called ECOG 0–1), with a life expectancy of at least 12 weeks, and whose health has not declined in the past two weeks.
• People whose blood test results show that bone marrow, liver, kidney, and blood-clotting function are within acceptable ranges as required by the trial (confirm with trial site for specific values).
• Women who could become pregnant must agree to use effective contraception throughout the study and for 6 months after treatment, must not be breastfeeding during or for 6 months after treatment, and must have a negative pregnancy test before starting.
• Men must agree to use barrier contraception during the study and for 6 months after treatment.
• People who are willing and able to sign a written consent form before joining.

Who may not be able to join:

• People whose cancer could not be fully removed by surgery, who have remaining cancer after surgery, or who only had a small partial lung removal (segmentectomy or wedge resection).
• People with very large or clustered cancerous lymph nodes in the chest, or where the cancer has grown into the heart, major blood vessels, oesophagus, or certain lung veins, or who have a specific type of lung cancer at the top of the lung (superior sulcus tumour).
• People who have previously received certain cancer treatments, including any EGFR-targeted therapy (called EGFR-TKIs), chemotherapy (other than standard platinum-based chemotherapy after surgery), immunotherapy, other targeted therapies, or certain traditional Chinese medicine anti-tumour treatments.
• People who have had major surgery within 4 weeks before starting the trial drug (not including placement of a vascular access line).
• People currently taking, or unable to stop at least one week before starting the trial drug, any medication or herbal supplement known to strongly affect a liver enzyme called CYP3A4.
• People who have had a serious infection in the past 4 weeks, or who have been on antibiotic treatment (by drip or by mouth) for an active infection in the past 2 weeks.
• People with any currently active infection, including hepatitis B, hepatitis C, or HIV.
• People who have been on continuous steroid treatment for more than 30 days within the past 30 days, who require long-term steroid use, or who have immune system disorders or a history of organ transplant.
• People with severe or uncontrolled conditions such as high blood pressure or diabetes.
• People with certain heart conditions, including abnormal heart rhythm readings on an ECG, a specific measure of heart electrical activity (QTcF) above 470 milliseconds, certain structural heart issues, risk factors for dangerous heart rhythms, or a reduced heart pumping function (ejection fraction below 50%).
• People currently taking or needing to take medications known to affect heart rhythm in a specific way (QT prolongation).
• People with a history of a lung condition called interstitial lung disease (ILD), lung inflammation caused by radiation that needed steroid treatment, or any currently active ILD.
• People who have had another cancer within the past five years, except for certain fully treated skin cancers or cervical carcinoma in situ.
• People with serious digestive system problems that would affect how the trial drug is absorbed, such as difficulty swallowing, persistent nausea and vomiting, major bowel surgery, ongoing diarrhoea, certain stomach conditions (confirm with trial site), Crohn's disease, or ulcerative colitis.
• People with a known allergy or sensitivity to the trial drug (SH-1028) or to drugs with a similar structure.
• People with severe, uncontrolled eye conditions that the trial doctor considers a safety risk.
• People currently participating in another clinical trial, or who have taken another trial drug within the past 4 weeks or within 5 half-lives of that drug.
• People with serious liver conditions including hepatic encephalopathy, hepatorenal syndrome, or moderate-to-severe liver cirrhosis (Child-Pugh grade B or higher).
• Women who are currently breastfeeding.
• People with any other condition that, in the trial doctor's opinion, could affect their safety or the reliability of the trial results.

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