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:

• People who are willing and able to give written consent to participate in the trial.
• People aged 18 or older at the time of signing the consent form.
• People who have at least one measurable area of disease that has not previously been treated with local therapy (such as radiotherapy) and was not sampled during the screening process.
• People whose lung cancer has been confirmed by laboratory testing of tissue or cell samples to be non-squamous non-small cell lung cancer (NSCLC), at either a locally advanced stage (Stage IIIB or IIIC, where surgery or curative chemoradiotherapy is not appropriate) or a metastatic stage (Stage IV).
• People who are able to provide recent tumor tissue samples (from untreated areas) and blood samples, and whose cancer has been confirmed by a central laboratory to carry a specific genetic change called an EGFR PACC or L861Q mutation. (If tumor tissue cannot be accessed, the trial sponsor would need to be consulted.)
• People who have not previously received any systemic (whole-body) treatment for advanced or metastatic NSCLC. Prior chemotherapy or chemoradiotherapy given before or after surgery is allowed if it was completed at least 12 months before the cancer returned or progressed.
• People with a general health and activity level rated as 0 or 1 on the standard ECOG scale, meaning they are either fully active or have only minor limitations in physically demanding activities (confirm with trial site).
• People with a life expectancy of at least 12 weeks.
• People whose blood counts and organ function (such as liver and kidneys) are within acceptable levels based on tests done within 14 days before starting treatment, without having needed a blood transfusion or certain white blood cell boosting injections in the two weeks before those tests.
• Women who could become pregnant must agree to either abstain from sexual activity or use contraception, and must not donate eggs during the trial period.
• Men who have not been surgically sterilised must agree to either abstain from sexual activity or use contraception, and must not donate sperm during the trial period.
• People with cancer that has spread to the brain may be eligible if they meet specific additional conditions set out in the trial protocol (confirm with trial site).

Who may not be able to join:

• People whose cancer contains more than 10% of certain cell types, including neuroendocrine carcinoma, sarcomatoid carcinoma, or squamous cell components, confirmed by laboratory testing.
• People whose cancer has a known genetic change for which other approved targeted treatments already exist, such as ALK, ROS1, RET, NTRK, BRAF V600E, or MET exon 14 mutations.
• People who have previously received systemic anti-cancer treatment (such as chemotherapy, targeted therapy, or immunotherapy) for advanced or metastatic NSCLC (prior treatment before or after surgery may be an exception — see inclusion criteria above).
• People who have received high-dose chest radiotherapy (more than 30 Gy) within the past 6 months, or radiotherapy to any area outside the chest within the past 4 weeks (brain radiotherapy may be an exception — confirm with trial site).
• People who have ever received any treatment specifically targeting EGFR, including any investigational EGFR drugs.
• People who have taken strong medications that significantly affect how the body processes certain drugs (strong CYP3A4 inhibitors within 7 days, or inducers within 21 days before the first dose) (confirm with trial site).
• People who have taken traditional Chinese anti-cancer medicines within 2 weeks before the first dose.
• People who have taken certain immune-modulating medications (such as interferon, IL-2, or thymosin) within 2 weeks before the first dose.
• People who have had a major injury or surgery within 4 weeks before starting treatment.
• People with significant stomach or bowel problems, including moderate or severe stomach lining damage, bowel blockage or perforation, chronic diarrhoea, short bowel syndrome, major stomach surgery, inflammatory bowel disease, or an inability to swallow tablets.
• People with serious uncontrolled conditions affecting other body systems.
• People with severe active or ongoing infections.
• People who have a history of, or currently have, lung inflammation not caused by infection (interstitial lung disease or non-infectious pneumonia), or who have unexplained changes on lung imaging at the time of screening.
• People with serious heart or cardiovascular problems, either currently or in their medical history.
• People whose tumour is growing into or very close to critical nearby structures (such as the heart, major blood vessels, or oesophagus) in a way that creates a high risk of bleeding or abnormal connections forming between organs. (Exceptions may be considered by the treating doctor if the risk is assessed as very low.)
• People with serious lung conditions, including a blood clot in the lungs within the past 3 months, severe asthma, severe COPD, severely restricted lung function, or autoimmune or connective tissue conditions that affect the lungs (such as rheumatoid arthritis or sarcoidosis).
• People who still have side effects from previous cancer treatment that are rated above a mild level (Grade 1), except for hair loss or nerve-related symptoms.
• People who have or have had another cancer at the same time, unless it is one of a limited number of cancers that have been fully cured (such as certain skin cancers, superficial bladder cancer, early-stage breast or cervical changes, papillary thyroid cancer, or other cancers successfully treated at least 3 years ago with no signs of return).
• People who are pregnant, breastfeeding, or planning to become pregnant within 6 months after completing treatment.
• People who are not able to follow the trial's procedures or attend required follow-up visits.
• People with a known allergy or sensitivity to furmonertinib or any of its ingredients.
• People with a known history of allergic reactions to pemetrexed, cisplatin, or carboplatin.
• People who, in the opinion of the trial investigator, have other factors that make participation unsafe or impractical, including alcohol or drug misuse, serious mental or physical health conditions requiring treatment, significant abnormal laboratory results, or personal and social circumstances that could affect safety or data quality.

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