Non-small cell lung cancer
Conditions
Interventions
Control group:Afatinib 40mg, orally taken once daily
Experimental group:FHND9041 80mg, orally taken once daily
Sponsors
Cancer Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years, gender is not limited; 2. Locally advanced or metastatic non-small cell lung cancer diagnosed by histopathology or cytopathology (including recurrence after previous surgical treatment or newly diagnosed stage IIIb, IIIc or IV patients, lung cancer The staging standard is in accordance with the 8th edition of AJCC); 3. Have not received any systemic anti-tumor therapy (such as standard chemotherapy, targeted therapy, biological therapy, immunotherapy, etc., except for local treatment for non-target lesions); patients who have received adjuvant therapy or neoadjuvant therapy (chemotherapy, radiotherapy or other treatments) can be included in the group if their disease progresses 6 months after the end of treatment; 4. Has one of two common EGFR-positive gene mutations that are sensitive to EGFR-TKI treatment, including exon 19 deletion or L858R; 5. At least one tumor lesion at baseline can meet the following requirements: (1) No radiotherapy or biopsy during screening (if the subject has only one measurable lesion, needle aspiration cytology can be accepted the genetic status is confirmed, but the imaging examination as the baseline must be performed at least 7 days after the puncture examination); (2) It can be accurately measured, and the longest diameter of the baseline period is >= 10 mm (if it is a lymph node, the short axis is required to be >= 15 mm); (3) Either CT or MRI can be tested, but the same test should be used for subsequent evaluations; 6. The ECOG physical status score is 0-1; 7. The life expectancy is >= 3 months; 8. The serum pregnancy test of all women of childbearing age must be negative, and male and female subjects with fertility must agree to maintain abstinence or take effective contraceptive measures during the study and for at least 3 months after the last use of the test drug; 9. The subject has a good understanding, understands the purpose and test procedures of the test, and can follow the protocol requirements and be able to cooperate with the study Participants conduct relevant visits, voluntarily participate in the trial, and sign written informed consent.
Exclusion criteria
Exclusion criteria: 1. Have received the following pre-treatment: (1) Have undergone major surgery within 28 days before the first dose of study drug is administered(the definition of major surgery refers to the level 3 and level 4 surgery specified in the Administrative Measures for the Clinical Application of Medical Technology implemented on May 1, 2009); (2) Received local radiotherapy or palliative radiotherapy for bone metastasis within 14 days before the first study drug administration; (3) Subjects who have received a strong CYP3A4 inhibitor or a strong inducer within 7 days before the first administration, or need to continue to receive these drugs during the study period; (4) Subjects who have received Chinese herbal medicines and proprietary Chinese medicine preparations for anti-tumor indications within 7 days before the first administration, or need to receive these drugs during the study period; (5) Subjects who are receiving drug treatments that are known to prolong the QTc interval or may cause torsades de pointes and need to continue to receive these drugs during the study period; 2. At the beginning of the study treatment, there was an unhealed toxic reaction of grade >= 2 (NCI-CTCAE 5.0 standard) related to the previous treatment (except for hair loss and grade 2 neuropathy caused by platinum drugs); 3. Subjects with spinal cord compression or brain metastases (except for those who are asymptomatic, stable, and do not need to be treated with steroids for at least 4 weeks before the start of the study treatment. Subjects who have received local radiotherapy for brain metastases must be completed at the end of the radiotherapy Later, the symptoms of brain metastasis were stable for 28 days or more to be included in the group); 4. There is any clinical evidence suggesting that the subject has a severe or uncontrolled systemic disease, such as hypertension that cannot be controlled by drugs, active bleeding physique, etc. The researcher believes that the subject is not suitable for participating in the trial or affecting the subject Diseases of compliance with research protocols; 5. There is active infection and medical treatment is required, such as HBV(HBsAg positive, HBV-DNA > 1000 cps/ml or 200 IU/ml and AST or ALT > 2.0 ULN), HCV(HCV antibody positive and HCV-RNA >= 1000 IU/mL), HIV and syphilis, etc.; 6. Clinically serious abnormal gastrointestinal function, which may affect the intake, transport or absorption of the study drug, such as inability to take the drug orally, uncontrollable nausea or vomiting, history of extensive gastrointestinal resection, uncured recurrent diarrhea, uncured gastric diseases, Crohn's disease, and ulcerative colitis that require long-term use of PPI acid-suppressing drugs; 7. Meet any of the following cardiac standards: (1) The average QT interval(QTcF) corrected by Fridericia's formula after 3 ECG examinations in the resting state should meet: male > 450 ms, female > 470 ms; (2) Various clinically significant heart rhythm, cardiac conduction, resting ECG morphological abnormalities, such as complete left bundle branch block, III degree conduction block, II degree type II block, PR interval > 250 ms, myocardial infarction occurred within 6 months; (3) There are various risk factors that may increase the risk of QTc prolongation or the risk of arrhythmia events, such as heart failure, moderate or severe hypokalemia, congenital long QT syndrome, family history of long QT syndrome, family histor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Overall survival;Duration of response;Disease control rate;Quality of life; | — |
Countries
China
Contacts
Public ContactShi Yuankai
Cancer Hospital Chinese Academy of Medical Sciences
Outcome results
None listed