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 to 75 years at the time of signing the consent form, regardless of sex
• People who have been diagnosed (confirmed by tissue or cell sample) with a type of lung cancer called non-squamous non-small cell lung cancer (NSCLC) that has come back or spread, and cannot be removed by surgery or cured with a combination of chemotherapy and radiation
• People whose cancer has a confirmed EGFR gene mutation — specifically an exon 19 deletion or an L858R mutation — either on its own or alongside other EGFR mutations, including a T790M mutation; local laboratory results are acceptable if the testing method meets certain quality standards
• People who have previously been treated with EGFR-targeted therapy (called EGFR-TKIs), and if applicable, no more than one course of platinum-based chemotherapy, with confirmed evidence that the cancer has continued to grow despite treatment
• People who have at least one measurable area of cancer that can be tracked using standard imaging guidelines (RECIST v1.1)
• People with a general health and activity level rated as 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activities)
• People with an estimated life expectancy of at least 12 weeks
• People whose blood and organ function results meet the required levels (covering blood cell counts, liver function, kidney function, and clotting), as assessed at screening — no blood transfusions or growth factor injections are allowed in the 14 days before these tests
• Women who could become pregnant and are sexually active with male partners who have not had a vasectomy must have a negative pregnancy blood test within 7 days before the first dose, and must agree to use highly effective contraception from signing the consent form until 7 months after the last dose of JS212 or 2 months after the last dose of JS111, whichever is longer, and must not plan to become pregnant during this time
• Men who have not had a vasectomy and are sexually active with women who could become pregnant must agree to use effective contraception from signing the consent form until 4 months after the last dose of either study drug, and must not donate sperm during this time
• People who are willing to take part voluntarily and provide written consent

Who may not be able to join:

• People whose cancer has been confirmed to contain small cell lung cancer, large cell neuroendocrine carcinoma, sarcomatoid features, or more than 10% squamous cell component
• People with known cancer spread to the membranes surrounding the brain and spinal cord (leptomeningeal metastases)
• People with brain metastases that are causing symptoms; people with brain metastases that are not causing symptoms may still be considered if a doctor assesses them as stable, under specific conditions (confirm with trial site)
• People with uncontrolled fluid build-up around the lungs, heart, or abdomen that requires draining more than once a month
• People with spinal cord compression that has not been treated, or that was previously treated but has not been confirmed as stable for at least 4 weeks before joining
• People who have received chemotherapy or similar treatments within 4 weeks or 5 half-lives (whichever is shorter) before the first dose, small-molecule targeted therapy within 7 days, or localised radiotherapy within 2 weeks
• People who have taken strong medications that significantly affect how a particular liver enzyme (CYP3A) processes drugs within 14 days before the first dose, or who would need to continue taking them during the trial
• People currently taking or needing to take medications known to affect heart rhythm in a specific way (QT interval prolongation or torsades de pointes risk)
• People who have received any experimental drug within 4 weeks or 5 half-lives before the first dose (whichever is shorter)
• People currently participating in another clinical trial that involves an active treatment (observational studies or follow-up phases of completed trials may be acceptable — confirm with trial site)
• People who have had major surgery such as brain, chest, or abdominal surgery within 4 weeks before the first dose
• People who still have side effects from previous cancer treatment that have not recovered to a mild or acceptable level (some exceptions, such as hair loss, nerve effects, or underactive thyroid, may be allowed at the investigator's discretion)
• People with a known allergy or sensitivity to any of the study drugs or their ingredients
• People whose heart electrical activity, as measured by ECG, shows a QTcF interval of 450 ms or more (men) or 470 ms or more (women), averaged across three measurements
• People with clinically significant heart rhythm problems, including certain types of heart block or a prolonged PR interval (confirm with trial site for specifics)
• People with risk factors for a specific dangerous heart rhythm, such as significantly low potassium levels or a family history of long QT syndrome
• People whose heart pumping function (left ventricular ejection fraction) is below 50%
• People with conditions that affect the ability to take oral medication, including persistent vomiting, uncontrolled diarrhoea, major bowel removal, Crohn's disease, or ulcerative colitis
• People with a history of or suspected lung conditions such as interstitial lung disease, drug-related or idiopathic pneumonitis, or pulmonary fibrosis (mild radiation-related lung inflammation may be acceptable — confirm with trial site)
• People with severe or uncontrolled eye conditions that could be made worse or that may require surgery during the trial (non-urgent cataracts may be acceptable — confirm with trial site)
• People who have had a severe infection within 4 weeks before the first dose, signs of active lung inflammation on imaging, or who have needed antibiotic treatment within 2 weeks before the first dose (not including preventive antibiotic use)
• People with a history of immune system disorders, including HIV, inherited or acquired immune deficiency, or prior organ or stem cell transplantation
• People with active tuberculosis, a history of active tuberculosis within the past year, or a history of tuberculosis from more than a year ago that was not properly treated
• People with active hepatitis B (meeting specific viral load thresholds) or active hepatitis C (with detectable levels of the virus in the blood)
• People who have had another cancer requiring treatment within the past 5 years, with some exceptions for certain low-risk cancers that have been fully treated (such as certain skin cancers, cervical or breast carcinoma in situ, localised prostate cancer, or papillary thyroid cancer)
• Women who are pregnant, breastfeeding, or planning to become pregnant during the study
• People with serious uncontrolled health conditions including heart failure, uncontrolled high blood pressure, unstable chest pain (angina), uncontrolled abnormal heart rhythms, major seizure disorders, certain vascular conditions, stroke or mini-stroke history, or significant psychiatric or social conditions that could affect the ability to follow the study requirements
• People who, in the trial doctor's opinion, have any condition that could put their safety at risk, affect the quality of the study data, or lead to them leaving the trial early

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