Lung Cancer
Conditions
Interventions
treatment group:Afatinib, Pemetrexed and Carboplatin
Sponsors
Shandong Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Aged 18 to 75 years; 2) Life expectancy was more than 3 months; 3) At least one measurable lesion other than cranial brain was confirmed according to RECIST 1.1; 4) Patients with stage IV non-squamous cell NSCLC confirmed by histopathology according to the 8th edition of Lung cancer staging relies on the TNM system designed jointly by the UICC (Union Internationale Against Cancer) and the AJCC (American Joint Committee on Cancer). 5) The ECOG physical score was 0-2; 6) Have not received any systemic anti-tumor therapy for advanced diseases. If the patient has received platinum-containing adjuvant chemotherapy or neoadjuvant chemotherapy before, and the disease progresses to stage IV more than 6 months after the end of the last treatment, he/she may participate in this clinical study. 7) Gene test from tumor tissues confirmed EGFR sensitive mutation positive (including classical mutation and non-classical mutation :19del, L858R, L861Q, G719X, S768I); 8) No brain metastasis, or accompanied by asymptomatic brain metastasis, or symptomatic brain metastasis after treatment which change to stable; 9) Adequate hematological function: neutrophil absolute count >=1.5x10^9/L, platelet count >= 100x10^9/L exclusion, hemoglobin >= 90 g/L; 10) Adequate liver function: all patients whose total bilirubin level is = 50ml/min (Cockcroft-Gault formula); 12) Adequate coagulation function: international standardized ratio (INR) or prothrombin time (PT) <=1.5 times the normal upper limit. If the patient is receiving anticoagulant therapy, as long as INR/PT is within the prescribed range of anticoagulant drugs; 13) Female patients should use effective contraception for at least 180 days after discontinuing treatment.Women of reproductive age were confirmed to have negative urine pregnancy tests or serum pregnancy tests within 3 days prior to the first study drug administration. 14) Patient understand and sign informed consent voluntarily.
Exclusion criteria
Exclusion criteria: 1) Histology showed squamous cell NSCLC.Mixed cell types must distinguish the dominant cell morphology (non-squamous cell NSCLC component > 50% can be enrolled, otherwise excluded.Small cell carcinoma, neuroendocrine carcinoma and sarcomas were excluded. 2) Patients with non-sensitive EGFR mutations or without EGFR mutations; 3) Patients with meningioma or meningioma metastasis or unstable brain metastasis; 4) Not recovered from toxicity and/or complications caused by any intervention prior to initiation of treatment (i.e., Grade 1 nausea, vomiting or diarrhea (CTCAE version 5.0), or other gastrointestinal disorders; 6) Patients who have experienced any arterial thrombosis, embolism or ischemia in the past 6 months and whose condition is not improved or unstable after corresponding treatment, such as unstabilized myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack after treatment; 7) Other malignancies diagnosed in the past 5 years, excluding radical basal cell carcinoma of the skin, skin squamous cell carcinoma and/or radical resection of carcinoma in situ; 8) Previous chemotherapy or egfr-tkis treatment;Adjuvant or neoadjuvant, time from last treatment to recurrence?6 months; 9) Confirmed allergy or contraindication to pemetrexed, carboplatin, afatinib/or its excipients; 10) NSCLC patients who did not receive chemotherapy or who were estimated to be intolerant to chemotherapy; 11) Positive baseline pregnancy test of pregnant or lactating female patients or fertile females; 12) Female patients of childbearing age who are unwilling to take effective contraceptive measures during the whole trial period and within 6 months after the end of the trial or male patients with family planning; 13) Have bad habits such as drug and alcohol abuse.Binge drinking refers to drinking four or more times in about 2 hours. The guidelines for one drink are 150ml of wine, 350ml of beer or 50ml of 80-degree liquor. 14) A clear history of neurological or psychiatric disorders, including epilepsy or dementia; 15) Anything that interferes with the clinical trial, hinders the full participation of the subjects, or is not in the best interests of the subjects as considered by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;ORR;DCR;TTR;DOR;Adverse events; | — |
Countries
China
Contacts
Public ContactLiu Jie
Shandong Cancer Hospital
Outcome results
None listed