NSCLC
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Signed Informed Consent Form; 2.Male or female patients aged 18 to 75 years; 3.Had an Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1; 4.Had a histologically or cytologically confirmed stage iiib/iiic (American Joint Committee on Cancer [AJCC] 8th edition) NSCLCand previously treated failure with at least one lines of EGFR TKI therapy, meanwhile once more biopsy (histology and cytology or hematology) found there were no sensitivity of EGFR mutations; 5.At least one measurable lesion according to RECIST 1.1.
Exclusion criteria
Exclusion criteria: 1.Tissue or cytopathological diagnosis of patients with adenosquamous carcinoma and compound SCLC; 2.Once more genetic testing revealed that ALK fusion, ROS1 fusion, BRAF mutation, ERBB2 (HER2) amplification/mutation, RET rearrangement, MET14 exon jump mutation, and NTRK fusion were positive; 3.Previously treated with neoadjuvant and adjuvant EGFR-TKI, and the disease recurred; 4.Priviously treated with first-line systemic chemotherapy before EGFR-TKI treatment, those who had previously received neoadjuvant therapy, adjuvant chemotherapy or chemoradiotherapy without treatment interval >=6 months were allowed to be included; 5.Patients with active brain metastases or meningeal metastases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective response rate;Disease control rate;Safety; | — |
Countries
China
Contacts
The First Affiliated Hospital of the Air Force Medical University