Non-Small Cell Lung Cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult patients, regardless of gender, aged from 18 to 70 years with histologically or cytologically confirmed NSCLC at stages IIIB or IV; 2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2; 3. All patients received 4 to 6 cycles of platinum-based first-line chemotherapy, from 4 to 8 weeks, and were evaluated as SD or PR after the first line chemotherapy; 4. Patients were required to have at least 1 measurable lesion (lesions were defined by Response Evaluation Criteria in Solid Tumors (RECIST, 1.1). If patients have ever received radiotherapy, the disease in the field of radiotherapy cannot be the target lesions; 5. Adequate organ function and CBC results; 6. Life expectancy of at least 3 months; 7. Women participants should have negative pregnancy test results; 8. All the participants should take contraception measures during the study period; 9. Participants should sign informed consent before the study.
Exclusion criteria
Exclusion criteria: 1. Patients receiving immunosuppressant drugs 1 month before study or receiving other immunotherapy 3 months before; 2. Patients receiving corticosteroid within 1 month before the research (including oral, intramuscular or intravenous injection). Inhaled corticosteroid for for respiratory insufficiency or for local use were not excluded; 3. Patients with uncontrolled epilepsy seizure, central nervous system dysfunction or cognitive ability lose due to psychosis; 4. Patients with CNS metastasis (confirmed or suspicious); 5. Patients with chronic alcohol or drug abuse within 6 months before the research; 6. Patiens who are pregnant or lactating or those who refused to take contraception measures during the study were excluded; 7. Patients with a history of severe allergy or allergic constitution; splenectomy; 8. Patients with autoimmune disease or secondary immunodeficiency (such as AIDS, et al); 9. Patients with secondary malignancy within 5 years (except for basal cell carcinoma of the skin or intraepithelial carcinoma of the cervix) were also excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| maximum-tolerated dose;antiEGF antibodies detection;Serum EGF concentration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical response evaluation; | — |
Countries
China
Contacts
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences