Phase 2 Rare Disease 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 who have given written consent before any study procedures begin
• People aged 18 years or older
• People who are generally well enough to carry out light activity or normal daily tasks (a health rating of 0 or 1 on a standard scale), whose health has not declined in the 2 weeks before joining, and who are expected to live at least 12 weeks
• People whose lung cancer has been confirmed by a tissue or cell sample as a specific type called non-squamous non-small cell lung cancer (NSCLC)
• People whose cancer has been assessed as locally advanced (Stage III), cannot be removed by surgery, and is suitable for a full course of radiation therapy
• People whose cancer has a specific type of uncommon EGFR gene mutation (not the common 19del, L858R, or T790M types), confirmed by genetic testing at a qualified hospital — the specific mutation types are listed in the trial's appendix (confirm with trial site)
• People who have not had any previous systemic cancer treatment or radiotherapy for this stage of lung cancer, including chemotherapy, targeted therapy, immunotherapy, biological therapy, or any experimental drug treatment
• People who have at least one tumour that can be clearly measured by standard imaging (RECIST 1.1 criteria), has not been previously treated with radiation, and was not biopsied during the screening period — or if it was biopsied, baseline imaging was done at least 14 days after the biopsy
• Women who are not pregnant, not breastfeeding, are using highly effective contraception for at least 2 weeks before the first dose, and have a negative pregnancy test — or women who meet certain criteria showing they are not able to become pregnant, such as being postmenopausal, having had surgical sterilisation (hysterectomy, removal of both ovaries, or removal of both fallopian tubes), or meeting specific hormone level criteria (confirm with trial site)
• Men who are willing to use barrier contraception during the study
• People who are able to follow the study procedures and take oral (swallowed) medication

Who may not be able to join:

• People whose lung cancer type is squamous cell carcinoma of the lung or small cell lung cancer
• People with a known history of allergic reactions to firmonertinib (the study drug) or to drugs with a similar chemical structure
• People whose cancer has the common EGFR mutations known as exon 19 deletion or exon 21 L858R
• People whose cancer has spread to other parts of the body (metastatic disease), or whose cancer is not suitable for a full course of radiation therapy, or whose tumour is too large for radiation to be safely delivered within safe dose limits for surrounding healthy tissue
• People with a specific type of lung cancer affecting the top of the lung (superior sulcus), or rare types including large cell neuroendocrine carcinoma or sarcomatoid tumour
• People who, before the first study dose, have received any of the following:
  • Any previous treatment with an EGFR-targeted drug (EGFR-TKI)
  • Fluid drainage treatment into the chest cavity, unless the fluid has been stable for 28 days or more
  • Major surgery within 28 days before the first dose
  • Certain strong medications that affect how the study drug is processed by the body (strong CYP3A4 inhibitors or inducers) within 7 days before the first dose, or those who need to continue taking these medications during the study
  • Traditional Chinese medicine or Chinese patent medicines used for cancer treatment within 7 days before the first dose, or those who need to continue these during the study
  • Medications known to affect heart rhythm in a specific way (prolong QTc or cause Torsade de Pointes) that must continue during the study
  • Other experimental drugs stopped less than 5 half-lives or 2 months before the first dose (whichever is the longer period)
• People who still have side effects from previous cancer treatment that have not settled to a mild level (Grade 1 or below on a standard scale), except for hair loss or mild-to-moderate nerve-related symptoms in the hands or feet
• People with unstable fluid build-up around the lungs
• People who have had another cancer diagnosis within the past 5 years, except for certain well-controlled skin cancers, cervical carcinoma in situ, or ductal carcinoma in situ of the breast
• People with active or recent serious digestive system problems, such as stomach or bowel ulcers, bowel inflammation, bowel perforation or fistula, uncontrolled nausea or vomiting, chronic gut conditions, inability to swallow tablets, or who have had extensive bowel removal surgery that could prevent the drug from being properly absorbed
• People with serious uncontrolled conditions such as high blood pressure, diabetes, active bleeding, or active infections including Hepatitis B (with certain virus levels), Hepatitis C, or HIV
• People with a history of, or current evidence of, a lung scarring condition called interstitial lung disease (ILD), including drug-related ILD or previous radiation-related lung inflammation that required steroid treatment
• People with any known damage or disease affecting the cornea (the surface of the eye)
• People whose blood test results within 28 days before the first dose show that the bone marrow or organs are not functioning well enough — including low blood cell counts, abnormal liver function, poor kidney function, or abnormal blood clotting results (specific laboratory thresholds apply — confirm with trial site)
• People with certain heart concerns, including an abnormal heart rhythm reading on an ECG, a specific electrical measurement of the heart (QTc interval) that is too long, poor heart pumping function, a heart attack or serious heart condition within the past 6 months, or moderate-to-severe heart failure
• People who are pregnant or breastfeeding
• People who the trial investigator believes are unlikely to follow the study procedures or who have other circumstances making participation unsuitable

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