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New treatment option for Patients With Advanced Non-small Cell Lung Cancer With Meningeal...
Official title Zorifertinib With Osimertinib for NSCLC With Meningeal Progression
ClinicalTrials.gov ID: NCT07361705
What this study is testing
What is Zorifertinib and Osimertinib Combination Therapy?
Zorifertinib and Osimertinib Combination Therapy is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for patients with advanced non-small cell lung cancer with meningeal progression after osimertinib treatment.
Also referred to as AZD3759, AZD9291.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a clinical trial that aims to test Zorifertinib when used together with a known drug, Osimertinib. The goal is to learn if this combination is safe and works for people with advanced Non-Small Cell Lung Cancer (NSCLC) whose cancer has spread to the membranes surrounding the brain and spinal cord (a condition called leptomeningeal metastases) after being treated with Osimertinib.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- For inclusion in the study, patients must meet all of the following criteria.
- The patient or the guardian is required to understand and sign the informed consent form of this study.
- During the screening period, people must have a previous histological or cytological diagnosis of NSCLC with a sensitising EGFR mutation (including...
- Only patients who have developed meningeal progression after osimertinib treatment (at a standard dose of 80 mg QD; if the dose is 160 mg QD, it must...
- people with leptomeningeal metastases should have the positive results of cerebrospinal fluid (CSF) cytology. people with negative CSF cytology but...
You likely can't join if
- Patients must not enter the study if any of the following exclusion criteria is met:
- people who plan to receive brain radiotherapy or intrathecal injection during the period from signing ICF to study medication.
- Radiotherapy history within 28 days before study drug administration is not allowed for enrollment, and palliative radiation to the skeleton...
- people who have undergone major surgery (e.g. intrathoracic, intraperitoneal or pelvic surgery) within 4 weeks prior to the first dose of study...
- In addition to NSCLC, there are other malignant tumors, or a history of other malignant tumors within 5 years, except for the following cases...
- Suffering from clinically significant and uncontrollable cardiac disorder and/or heart-related events within 6 months, such as: (1) Unstable angina...
See the full eligibility criteria
- For inclusion in the study, patients must meet all of the following criteria.
- The patient or the guardian is required to understand and sign the informed consent form of this study.
- During the screening period, people must have a previous histological or cytological diagnosis of NSCLC with a sensitising EGFR mutation (including L858R and/or Exon19Del).
- Only patients who have developed meningeal progression after osimertinib treatment (at a standard dose of 80 mg QD; if the dose is 160 mg QD, it must be reduced to 80 mg QD for at least 1 week before receiving study...
- people with leptomeningeal metastases should have the positive results of cerebrospinal fluid (CSF) cytology. people with negative CSF cytology but highly suspected of leptomeningeal metastases in combination with CSF...
- people with meningeal progression and brain parenchyma progression are allowed to be enrolled.
- people must have at least one repeatedly evaluable, measurable target lesion (intracranial and/or extracranial) according to mRECIST 1.1 criteria or a repeatedly evaluable lesion according to RANO-LM criteria.
- people must be ≥ 18 years old before signing the informed consent form (ICF).
- If there are neurological symptoms, the following conditions must be met: Able to take and swallow oral medication; No need to increase the hormone dose to enhance control of central nervous system symptoms for at least...
- All toxicities related to anti-tumor therapy (including radiotherapy) must have resolved to ≤ Grade 1 (CTCAE 5.0, it is sufficient for neurotoxicity related to platinum treatment to resolve to ≤ Grade 2 [CTCAE]) before...
- The screening period examination of patients must meet the followings:
- Neutrophil count ≥ 1.5 x 109/L
- Platelet ≥ 100 x 109/L
- Hemoglobin ≥ 9 g/dL
- Blood creatinine ≤ 1.5 x ULN, or creatinine clearance (Cockcroft-Gault formula) ≥ 50 mL/min
- Total bilirubin ≤ 1.5 x ULN (for patients with Gilbert's syndrome or metastases to liver, ≤3 x ULN is acceptable)
- Glutamic-oxaloacetic transferase ≤ 2 x ULN (for patients with metastases to liver, ≤ 3 x ULN is acceptable)
- Glutamic-pyruvic transaminase ≤ 2 x ULN (for patients with metastases to liver, ≤ 3 x ULN is acceptable)
- The estimated survival time of people is ≥ 6 weeks.
- Karnofsky Performance Status (KPS) scale score ≥ 60.
- Patients must not enter the study if any of the following exclusion criteria is met:
- people who plan to receive brain radiotherapy or intrathecal injection during the period from signing ICF to study medication.
- Radiotherapy history within 28 days before study drug administration is not allowed for enrollment, and palliative radiation to the skeleton occurring within 14 days before study drug administration is also not allowed...
- people who have undergone major surgery (e.g. intrathoracic, intraperitoneal or pelvic surgery) within 4 weeks prior to the first dose of study treatment or who have not yet recovered from the side effects associated...
- In addition to NSCLC, there are other malignant tumors, or a history of other malignant tumors within 5 years, except for the following cases: Complete resection of skin basal cell and squamous cell carcinoma and...
- Suffering from clinically significant and uncontrollable cardiac disorder and/or heart-related events within 6 months, such as: (1) Unstable angina within 6 months before the screening period; (2) Myocardial infarction...
- Strong CYP3A4 inducers or inhibitors;
- Drugs mainly metabolised by CYP3A4;
- Drugs that may cause QT interval prolongation or torsade de pointe. 8. Patients with a previous or concurrent HIV infection are not allowed to enroll. Patients who are HCV antibody positive can be enrolled if HCV-RNA is...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Shengyang, City, China
- Guangzhou, Province, China
- Henan, Province, China
- Shanxi, Province, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Shengyang, City, China; Guangzhou, Province, China; Henan, Province, China; Shanxi, Province, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.