Lung cancer
Conditions
Interventions
Experimental group:osimertinib plus chemotherapy
Sponsors
Affiliated Tumor Hospital of Guangxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Has signed a written informed consent; 2. Aged between 18 years and 75 years; 3. Complying with the study plan; 4. With at least one measurable lesion according to Recist 1.1; 5. Histological or cytological diagnosis of metastasis or recurrence stage ?B, ?C or IV (according to WHO the Eighth Edition Lung Cancer Stage Classification) NSCLC not suitable for operation and radical radio-chemotherapy; 6. Patients not receiving systemic treatment for local advanced or metastatic NSCLC; 7. NGS detection (targeting 150 genes) before treatment using tumor tissues indicating EGFR mutation (exon 19 deletion, or exon 21 L858R) and other concurrent mutations (TP53, Rb1, PTEN, Met, ERBB2, KRAS, BRAF, RET or ROS1); 8. With ECOG Performance Status equal to 0 or 1; 9. Life expectancy > 12 weeks; 10. Neutrophils count >= 1.5 x 10^9/ L (not supported by granulocyte colony stimulating factor), platelet count >= 100 x 10^9/l, and hemoglobin >= 90 g/L (without blood transfusion or erythropoietin support within 7 days); 11. Value of serum total bilirubin are = 60ml/min (Cockcroft Gault formula); 13. International standard ratio (INR) or prothrombin time (PT) <= 1.5 times of ULN; 14. For women of childbearing age, urine or serum pregnancy test should be negative within 3 days before receiving the first administration; 15. Men and women with a risk of pregnancy need to conduct effective contraception until at least 180 days after withdrawal from the trial.
Exclusion criteria
Exclusion criteria: 1. Patients with small cell lung cancer (including a mixture of small cell carcinoma and non-small cell lung cancer); 2. Within 2 weeks before the first administration, the Chinese patent medicine or immunomodulatory drug with anti lung cancer indications were systematically treated or received major operation within 3 weeks before the first administration; 3. Receiving lung radiotherapy with dose > 30 Gy within 6 months before the first administration; 4. Receiving palliative radiotherapy within 7 days before the first administration; 5. With clinical active diverticulitis, abdominal abscess, and gastrointestinal obstruction; 6. Before the start of administration, no full recovery from toxicity and/or complications caused by any intervention (excluding fatigue or hair loss); 7. Symptomatic central nerve metastasis. Patients with asymptomatic brain metastasis or stable symptoms after treatment of brain metastasis meeting the following criteria can be included: there are measurable lesions outside the central nervous system; no metastasis of the midbrain, mesocephalon, parencephalon, medulla oblongata or spinal cord; clinical stability to a minimum of 2 weeks; no hormone treatment within 3 days before the first administration; 8. Other malignancies diagnosed within 5 years before the first administration, excluding skin basal cell carcinoma, skin squamous cell carcinoma and/or in situ cancer with radical therapy; 9. Non-infective pneumonia requiring glucocorticoid treatment within one year before the first administration; existing interstitial lung disease; 10. The events of arteriovenous thrombosis occurred 12 months within one year before inclusion; 11. Active infection requiring systemic treatment; 12. Known mental illness or drug abuse with an impact on compliance with the trial requirements; 13. Human immunodeficiency virus (HIV) infection; 14. Untreated active hepatitis B; 15. Active HCV infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival;Objective response rate;Adverse events;Quality of life; | — |
Countries
China
Contacts
Public ContactYu Qitao
Tumor Hospital Affiliated to Guangxi Medical University
Outcome results
None listed