Non small cell lung cancer
Conditions
Interventions
Furmonertinib Group:Furmonertinib
Furmonertinib combined with bevacizumab Group:Furmonertinib combined with bevacizumab
Sponsors
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Cancer Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Disease related inclusion criteria: 1) The target population was advanced non-squamous non-small cell lung cancer (AJCC 8th TNM stage IV) confirmed by histology or cytology. EGFR exon 19 deletion mutation (19DEL) or exon 21 L858R point mutation (L858R) were confirmed by histological or cytological examination of the central laboratory, and these mutations could exist alone or together; 2) For patients with meningeal metastases: Confirmed by cerebrospinal fluid (CSF) cytology, or by two Radiological imaging specialists, meningeal metastases do not require measurable parenchymal or extracranial lesions; 3) For patients with brain metastases that can be objectively measured but without meningeal metastases: subjects have at least one CNS metastases that can be accurately measured according to the Response Evaluation criteria for solid tumors (RECIST 1.1) that were not previously irradiated and did not undergo tissue biopsy during the screening period; 4) Patients had not received systemic antitumor therapy for advanced/metastatic NSCLC, including standard chemotherapy, biotherapy, targeted therapy, immunotherapy, or investigational drug therapy (third-generation EGFR TKI, bevacizumab) before study drug therapy was initiated; Patients who had received adjuvant or neoadjuvant therapy (chemotherapy and/or radiotherapy) and did not progress within 6 months after treatment were allowed to enroll; Patients who had received local therapy (radiotherapy or pleural cavity perfusion therapy) were allowed to enroll if the lesion within the range of local therapy was non-target; General inclusion criteria: 1) Informed consent signed by the patient or his legal representative; 2) Age above 18 years; 3) ECOG score of 0-2 and no deterioration 2 weeks before enrollment; 4) Life expectancy = 12 weeks; 5) Able to comply with the study protocol and follow-up procedures, and able to receive oral medication; 6) Blood samples and cerebrospinal fluid samples can be provided and written informed consent for genetic research can be signed.
Exclusion criteria
Exclusion criteria: 1) Patients with non-lung adenocarcinoma, including lung squamous cell carcinoma or mixed histological type; 2) 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); 3) Confirmed EGFR 20 exon insertion mutations at any time after the initial diagnosis; 4) Patient who receive prior treatment including any of the following: Any Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI); The patients who have received intrapleural perfusion therapy can only be enrolled 28 days or more after the pleural effusion is stable; Major surgery within 4 weeks of the first dose of investigational product (IP); 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; 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; 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; 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; 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; 5) Prior treatment with any systemic anti-cancer therapy for advanced Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiation including chemotherapy, biologic therapy, target therapy, immunotherapy, or any investigational drug; 6) 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; 7) Recent active digestive diseases such as duodenal ulcer, ulcerative colitis, ileitis, intestinal perforation, intestinal fistula, or other conditions that may cause gastrointestinal bleeding or perforation as the researchers may prescribe. Or refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of furmonertinib; 8) Any evidence of corneal injury confirmed by ophthalmic examination using slit lamp evaluation; 9) 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; 10) Any evidence of severe or uncontrolled systemic disease, including uncontrolled hypertension and active bleeding, any disease that the investigator considered to be detrimental to the patient's participation in the study or to adherence to the protocol, or active infections including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV). Screening for chronic diseases is not required; 11) Inadequate bone marrow reserve or organ function; 12) QT prolongation or any cl
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| CNS progression-free survival;extracranial progression-free survival;Overall Objective response rate;CNS Objective response rate;Extracrania Objective response rate;Overall Disease control rate;CNS DCR;Extracranial DCR;Over Survival; | — |
Countries
China
Contacts
Public ContactYueyin Pan
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Cancer Hospital)
Outcome results
None listed