NSCLC
Conditions
Interventions
1:gefitinib combined with vinorelbine soft capsule
2:gefitinib monotherapy
Sponsors
National Cancer Center /Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The patients were 18-75 years old when they signed the informed consent; 2. Histological or cytological diagnosis of non-small cell lung cancer (NSCLC), stage IIIB or IV, and EGFR sensitive mutation is positive; 3. The patient has not previously received EGFR-TKI or any other systemic anti-tumor treatment; 4. The physical condition score (ECOG score) is 0-1; 5. The requirements of laboratory test value before medication are as follows: Neutrophils >= 2.0 * 109/L; Platelets >= 100 * 109/L; Hemoglobin >= 9 g/dL; Serum creatinine = 60 ml/min.
Exclusion criteria
Exclusion criteria: 1. Have previously received HER-targeted drug therapy (such as erlotinib, gefitinib, cetuximab and trastuzumab, etc.); 2. Other malignant tumors have appeared in the past 5 years, except for basal cell carcinoma of the skin and carcinoma in situ of the cervix; 3. During the EGFR test, the patient discovered a T790M resistance mutation in exon 20; 4. There are clinically uncontrolled active infections, such as acute pneumonia, hepatitis B or hepatitis C, etc.; 5. Those who have difficulty swallowing or have known problems with drug absorption; 6. Severe dysfunction of important organs such as heart, liver and kidney; 7. Pregnancy or breast feeding women or women who are likely to become pregnant have a positive pregnancy test before the first medication; 8. Patients with fertility but not willing to accept contraceptive measures or their sexual partners who are not willing to accept contraceptive measures; 9. The investigator believes that the patient's condition is not suitable for participating in this clinical study; 10. The investigator judges that the patient's compliance with this study is insufficient; 11. Those who are allergic to gefitinib, vinorelbine tartrate soft capsules and their excipients;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;ORR;DCR; | — |
Countries
China
Contacts
Public ContactXingsheng Hu
National Cancer Center /Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College.
Outcome results
None listed