Non-small cell lung cancer
Conditions
Interventions
A group:EGFR-TKI (1st or 3rd generation) + minocycline until disease progression (RECIST v1.1), withdrawal criteria met, or study termination criteria are met.
Minocycline is taken within 7 days prior
B Group:EGFR-TKI (1st or 3rd generation) + placebo until disease progression (RECIST v1.1), meeting withdrawal criteria, or study termination criteria. EGFR-TKIS does not limit the type.
Sponsors
The 901th Hospital of People Liberation Army
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Voluntarily sign a written informed consent form and be able to understand and comply with the trial protocol requirements. 2) >=18 years of age at the time of signing the informed consent form. 3) Histologically or cytologically confirmed metastatic non-small cell lung adenocarcinoma (AJCC 8th edition), and not suitable for radical surgery or radiotherapy. Mixed histological types with a predominance of adenocarcinoma components are acceptable. The tissue sample must not come from a tumor lesion that has been irradiated; new lesions that appear after local treatment can be used. 4) No prior systemic antitumor therapy for metastatic NSCLC, with EGFR sensitive mutations (deletion in exon 19 or L858R mutation in exon 21, either alone or in combination with other EGFR mutations). Patients who have received local treatment for more than 2 weeks can participate in the study if the lesions within the scope of local treatment are non-target lesions. Remarks: If the subject has previously completed radical surgery and adjuvant therapy for early-stage NSCLC, but later developed disease recurrence or metastasis, they can also be enrolled, provided that the interval between the end of their adjuvant therapy and the first dose of this study exceeds 6 months. If EGFR-TKIs were used as adjuvant therapy in the past, the subject cannot be enrolled. 5) ECOG score =10mm, and lymph node lesions should have a shortest diameter of >=15mm. 7) Voluntary agreement to use regular, sufficiently effective contraceptive measures throughout the entire study period and within 3 months after the last dose [For women: 1. Oral, injectable contraceptives, or implantable hormonal contraceptives; 2. Intrauterine devices or intrauterine contraceptive systems; 3. Barrier contraception: condoms with spermicidal effect or occlusive caps (diaphragms or cervical/vault caps). For men: 1. Condoms with spermicidal effect; 2. Surgical sterilization (e.g., bilateral vasectomy, bilateral epididymectomy)]. Premenopausal women with the potential to bear children (considered to have the potential for premenopausal fertility if: 1. They have not undergone bilateral tubal ligation, hysterectomy, or bilateral oophorectomy; 2. The time from their last menstrual period to screening is <2 years) must be excluded from pregnancy (i.e., negative pregnancy test within 7 days before the first dose); and must be non-lactating.
Exclusion criteria
Exclusion criteria: 1) Concurrent other malignancies (except for clinically cured carcinoma in situ of the cervix, basal cell or squamous cell carcinoma of the skin, and papillary thyroid carcinoma). 2) Patients with leptomeningeal metastases (LM) who cannot undergo contrast-enhanced MRI scans. 3) Patients with central nervous system (CNS) complications requiring urgent neurosurgical treatment (such as surgery). 4) Previous use of any EGFR TKI drugs for the treatment of NSCLC. 5) Previous use of any systemic antitumor therapy for locally advanced or metastatic NSCLC, including systemic chemotherapy, immunotherapy, biological therapy, etc. 6) Received traditional Chinese medicine and proprietary Chinese medicine preparations indicated for antitumor purposes within 2 weeks before the study drug treatment. 7) Patients who have undergone surgery within 4 weeks before the study drug treatment, except for minor surgeries that the investigator judges will not affect participation in the trial (such as tooth extraction); or patients who plan to undergo major surgery during the study period. 8) Patients with a significant worsening of symptoms or signs within 2 weeks before screening (such as a large amount of pleural effusion appearing within 2 weeks before screening, which can be considered for screening after controlling the pleural effusion), which the investigator judges to be unsuitable for the trial. 9) Any clinical evidence of severe or uncontrolled disease that the investigator considers unsuitable for participating in this clinical trial or may affect the patient's compliance with the study protocol, such as patients with hypertension that remains uncontrolled despite medication (SBP > 160 mmHg or DBP > 100 mmHg), patients with active bleeding tendencies, patients with active infections (such as hepatitis B, hepatitis C, syphilis, HIV antibody positive). Active hepatitis B is defined as: HBV DNA >= 2000 IU/ml (equivalent to 10^4 copies/ml); active hepatitis C is defined as HCV RNA above the detection limit. 10) Abnormal corrected QT interval (QTcF) results on resting ECG during the screening period, with retests taken at intervals of more than 4 hours, and an average QTcF of >=450 msec for males and >=470 msec for females across three ECG tests. Various clinically significant arrhythmias, conduction abnormalities, and resting ECG morphological abnormalities, such as complete left bundle branch block, third-degree atrioventricular block, second-degree atrioventricular block, PR interval >250 msec. Presence of factors that increase the risk of QTc prolongation or arrhythmic events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of first-degree relatives with long QT syndrome or sudden death under the age of 40 without apparent cause, known medications that prolong the QT interval. Echocardiography shows a left ventricular ejection fraction (LVEF) <=50% or other abnormalities judged by the investigator to be clinically significant. 11) History of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid treatment, or clinical evidence of active interstitial lung disease. 12) Any condition that affects the patient's ability to swallow medication or has oral absorption disorders, such as: severe chronic gastrointestinal diseases, previous gastrointestinal surgery, refractory nausea or vomiting symptoms, etc. 13) Any of the following laboratory abnormalities: Absolute neutrophil c
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Overall Survival;Safety and Tolerability; | — |
Countries
China
Contacts
Public ContactDonglai Lv
The 901th Hospital of People Liberation Army
Outcome results
None listed