Locally advanced or metastatic NSCLC (non-drug-resistant rare EGFR mutations only, including L861Q, G719X, and/or S768I)
Conditions
Interventions
Treatment group:Sutertinib maleate
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged 18 (including 18) years or above, gender is not limited. 2. Subjects with locally advanced or metastatic NSCLC confirmed by histopathology and/or cytopathology, and the number of previous chemotherapy lines is less than or equal to 1. It is planned to enroll about 10% of subjects who have undergone chemotherapy. 3. Non-drug-resistant rare EGFR mutations (tumor tissue biopsy samples), including one or more of L861Q, G719X, and S768I mutations (excluding other EGFR sensitive mutations and/or other driver genes), and are willing to provide enough tumor tissue biopsy samples for testing by one of the two designated local laboratories (for specific sample requirements, please refer to the relevant standard operating procedures or laboratory manuals of the designated local laboratory). 4. At least one measurable lesion according to RECIST1.1. 5. ECOG performance status score of 0, 1 or 2. 6. Expected survival time > 3 months. 7. Sufficient bone marrow, liver, kidney and coagulation function (no blood transfusion or blood products, no granulocyte colony-stimulating factor or other hematopoietic-stimulating factor correction within 2 weeks before the first administration of the study drug): (1) Bone marrow: absolute neutrophil count (ANC) >=1.5x10^9/L, platelet count >=90x10^9/L, hemoglobin >=90 g/L; (2) Liver: total bilirubin (TBIL) =50 mL/min (calculated by Cockcroft-Gault formula); (4) International Normalized Ratio (INR) <= 1.5. 8. Eligible subjects (male and female) of childbearing potential must agree to use reliable contraceptive methods (hormonal or barrier method or abstinence) during the trial and for at least 90 days after the last dose; female subjects of childbearing age must have a negative pregnancy test before enrollment; male subjects cannot perform sperm donation from the first dose to 90 days after the last dose. 9. All subjects must be informed about this study before accepting any inspection specified in this trial, and voluntarily sign a written informed consent form (ICF) approved by the ethics committee, and are willing to follow the experimental treatment protocol and visit plan.
Exclusion criteria
Exclusion criteria: 1. Received any epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) anti-tumor therapy before enrollment. 2. Received systemic anti-tumor therapy such as chemotherapy, immunotherapy, and radiotherapy (including radical radiotherapy or the proportion of bone marrow in the radiotherapy site is greater than 30%) within 4 weeks before enrollment; received local palliative radiotherapy for non-target lesions for the purpose of relieving symptoms, and Chinese medicine (including proprietary Chinese medicine) for tumor indications within 2 weeks before enrollment. 3. Have used drugs or foods that have strong inhibition or strong induction of cytochrome P450 (CYP) isoenzyme CYP3A4 within 14 days or 5 half-lives (whichever is longer) before enrollment. 4. Received major organ surgery (excluding needle biopsy) or suffered significant trauma within 4 weeks before enrollment. Note: Significant trauma refers to the severity of each subcategory >= grade 3 under the item ''trauma, poisoning, and procedural complications'' of the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 (v5.0). 5. At the time of screening, the adverse reactions of any previous treatment have not recovered to NCI CTCAE v5.0 severity evaluation = 3), malabsorption syndrome or any other condition that affects gastrointestinal absorption. 7. There are unstable central nervous system metastases or meningeal metastases with clinical symptoms, or there is other evidence that the subjects' central nervous system metastases or meningeal metastases have not been controlled, and are judged by the investigator to be unsuitable for enrollment; subjects with suspected cerebral or leptomeningeal lesions should be confirmed by computed tomography/magnetic resonance imaging (CT/MRI). 8. Past or current interstitial lung disease, radiation pneumonitis requiring hormone therapy or drug-related pneumonia, CT scan found idiopathic pulmonary fibrosis during screening; uncontrolled massive pleural effusion or pericardial effusion. 9. At the time of screening, there was an uncontrolled active infection (eg active tuberculosis infection, need for intravenous antibiotics, syphilis, human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, etc.). Note: Subjects with HBV surface antigen (HBsAg) positive, HBV-DNA=160 mmHg and/or diastolic blood pressure >=100 mmHg); acute myocardial infarction, congestive heart failure, stroke or other grade III or above cardiovascular and cerebrovascular events within 6 months before enrollment; at screening, echocardiography showed a left ventricular ejection fraction (LVEF) 480 ms (calculated according to the Fridericia formula). 11. There is a history of other serious systemic diseases (NCI CTCAE v5.0 severity evaluation >= grade 3), and the investigators judge that they are not suitable to participate in clinical trials. 12. Participated in other interventional clinical trials 4 weeks before
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease control rate;Progression-free survival;Disease progression time;Treatment failure time;Relief time;Overall survival;1-year progression-free survival;1-year survival rate; | — |
Countries
China
Contacts
Public ContactZhou Caicun
Shanghai Pulmonary Hospital
Outcome results
None listed