Furmonertinib in First-line Treatment of Patients With CNS Metastatic EGFR Mutation Positive NSCLC
Study Details
Study Description
Brief Summary
EGFR mutation positive advanced NSCLC patients with CNS metastases have poor prognosis, second-line furmonertinib dose at 160mg level in EGRF T790M mutation positive CNS metastatic NSCLC have provided relevant benefit with a high CNS PFS and CNS ORR. Whether CNS metastatic EGFR mutation positive NSCLC patients can benefit from first-line furmonertinib 160mg per day has not been reported. This study aims to investigate the efficacy and safety of furmonertinib 160mg per day in CNS metastatic EGFR mutant patients under first-line treatment of advanced NSCLC setting.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
This is a single arm, multicenter study which will recruit about 40 patients in China.
The study is designed to evaluate the efficacy and safety of furmonertinib in the first-line treatment of patients with EGFR mutations in advanced NSCLC with CNS metastases.
Furmonertinib is a third generation Epidermal Growth Factor Receptor (EGFR) tyrosine kinase inhibitor (TKI) that targets multiple Epidermal Growth Factor Receptor (EGFR) mutations. It will be administered orally at a dose of 160 mg per time, Q.D.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Furmonertinib furmonertinib 160 mg orally QD |
Drug: Furmonertinib
furmonertinib 160 mg orally QD
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Progression-free survival [The primary analysis of Progression-free survival (PFS) based on investigator assessment will occur when PFS maturity is observed at approximately 26 months after the first patient begin study treatment]
Progression-free survival (PFS) is defined as the time from beginning of study treatment until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdraws from randomized therapy or receives another anti-cancer therapy prior to progression.
Secondary Outcome Measures
- Central nervous system (CNS) progression-free survival [Central nervous system (CNS) progression-free survival (PFS) analysis based on investigator assessment will occur at approximately 26 months after the first patient begin study treatment.]
CNS PFS is defined as the time from beginning of study treatment until the date of objective progression of central nervous system or death (by any cause in the absence of CNS progression), regardless of whether the patient withdraws from study treatment or receives another anti-cancer therapy prior to progression.
- Objective Response Rate [Objective Response Rate analysis will occur when Progression-free survival (PFS) maturity is observed at approximately 26 months from the first patient begin study treatment.]
defined as the number (%) of patients with response of Complete Response or Partial Response.
- Disease Control Rate [Disease Control Rate analysis will occur when Progression-free survival (PFS) maturity is observed at approximately 26 months from the first patient begin study treatment.]
defined as the number (%) of patients with CNS lesion response of Complete Response or Partial Response.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Provide informed consent prior to any study specific procedures;
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at least 18 years of age;
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ECOG PS of 0 to 1 at screening with no clinically significant deterioration in the previous 2 weeks, life expectancy ≥12 weeks;
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Histologically or cytologically confirmed metastatic Non-Small Cell Lung Cancer (NSCLC);
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Patient with EGFR 19Del or L858R mutation diagnosed histologically or cytologically. The mutations above may exist alone or together;
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Patients must have untreated advanced Non-Small Cell Lung Cancer (NSCLC);
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According to RECIST 1.1, patients must have at least one central nervous system (CNS) metastatic tumor lesion at baseline that meets the following requirements: accurately and repeatably measurable at baseline, have no radiotherapy or biopsy;
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For premenopausal women with childbearing potential, a pregnancy test must be performed within 14 days before the first dose, and the pregnancy test (blood or urine test) must be negative; female subjects must not be lactating;
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Willing to use contraception;
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Voluntary and agree to follow the study treatment protocol as well as follow-up plan, and can accept the oral medicine treatment.
Exclusion Criteria:
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small cell lung carcinoma;
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History of hypersensitivity to active or inactive excipients of investigational product (IP) or drugs with a similar chemical structure or class to investigational product (IP);
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Confirmed EGFR 20 exon insertion mutations at any time after the initial diagnosis;
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Patient who receive prior treatment including any of the following:
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Any Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI);
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The patients who have received intrapleural perfusion therapy can only be enrolled 28 days or more after the pleural effusion is stable;
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Major surgery within 4 weeks of the first dose of investigational product (IP);
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Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of IP;
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CYP3A4 strong inhibitor or strong inducer is used within 7 days prior to the first dose, or need to receive these drugs during the study period;
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Traditional Chinese medicine and traditional Chinese medicine preparations with anti-tumor as indications and with adjuvant treatment of tumor is used within 7 days prior to the first dose, or need to receive these drugs during the study period;
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Patients who are receiving drugs known to prolong QTc interval or may cause torsade de pointe and need to continue to receive these drugs during the study period;
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The time from the treatment with any other investigational product or its analogue to the first dose does not exceed 5 half-lives of the drug or 14 days, whichever is longer;
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Prior treatment with any systemic anti-cancer therapy for advanced Non-Small Cell Lung Cancer (NSCLC) including chemotherapy, biologic therapy, target therapy, immunotherapy, or any investigational drug, except neoadjuvant or adjuvant therapy before 6 months prior to the first dose IP;
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At the beginning of study treatment, any unresolved toxic reaction to prior treatment is present, which exceeds Grade 1 in accordance with Common Terminology Criteria for Adverse Events (CTCAE) (except for alopecia), and exceeds Grade 2 for prior platinum treatment-related neuropathy;
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Spinal cord compression; symptomatic and unstable brain metastases, except for those patients who have completed definitive therapy, are not on steroids, and have a stable neurological status for at least 2 weeks after completion of the definitive therapy and steroids.
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Diagnosed other malignant tumors or had a history of other malignant tumors in last 5 years, except for skin basal cell carcinoma, cervical carcinoma in situ and breast ductal carcinoma in situ which have been effectively controlled;
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Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of IP;
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Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, and active infection, which in the Investigator's opinion makes it undesirable for the patient to participate in the trial;
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Past medical history of Interstitial Lung Disease (ILD), drug-induced Interstitial Lung Disease, radiation pneumonitis that required steroid treatment, or any evidence of clinically active Interstitial Lung Disease;
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Any evidence of corneal injury;
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Inadequate bone marrow reserve or organ function;
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QT prolongation or any clinically important abnormalities in rhythm and heart function;
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Patients who may have poor compliance with the research procedures and requirements, etc., as judged by investigators.
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Pregnancy or lactation.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hunan Cancer hospital | Changsha | Hunan | China |
Sponsors and Collaborators
- Hunan Province Tumor Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FORCE