Non-small Cell Lung Cancer
Conditions
Interventions
Group 1:Chemotherapy Alone
Group 2:Targeted Therapy Alone
Group 3:Chemotherapy Combined with Targeted Therapy
Sponsors
National Cancer Center/ National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Non-small cell lung cancer confirmed by pathology or cytology, and confirmed harboring EGFR rare mutations (with the exception of 19 deletion and 21 L858R point mutations) and other rare genetic mutation types including HER2 gene insertion mutation/amplification, RET gene fusion, c - MET gene mutation/amplification, BRAF gene mutation, ROS - 1gene fusion, KRAS gene mutation and NTRK gene mutation; (2) Aged 18 to 80 years; (3) Locally advanced or metastatic disease (stage IIIB-IV) and not suitable for radical surgery or radiotherapy; (4) The lesions can be measured by imaging (evaluating the efficacy according to RECIST1.1 in the solid tumor response assessment); (5) Life expectancy of at least 3 months; (6) Eastern Cooperative Oncology Group (ECOG) performance status (PS)=1; (7) The main organ function meeting the following: blood routine examination meeting the standards:ANC=1.5×10^9/L; PLT=80×10^9/L; Hb=90g/L;blood biochemical examination meeting the following standards: TBIL45ml/min (Cockcroft - Gault formula); (8) Signed and dated informed consent. Willingness and ability to comply with scheduled visits, treatment plans, laoratory tests, and other study procedure.
Exclusion criteria
Exclusion criteria: (1) EGFR common gene mutations (19 deletion mutation and 21 L858R point mutation) and ALK gene fusion; (2) Symptomatic brain metastases; (3) Accompanied by other malignant tumors or other active malignancies; (4) Function of important organs is incomplete; (5) Uncontrolled systemic diseases, including uncontrolled hypertension, proteinuria (Urine protein=++, or 24h urine protein quantitation=1.0g) and active bleeder physique, active infections, including hepatitis b, hepatitis c and human immunodeficiency virus (HIV) infection; (6) Factors which may affect the clinical study and the results of the study through researchers'judgment. t of clinical research and the judgment of research results; (7) other anti-tumor treatment was received before the first line treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Disease Control Rate;Overall Survival;Adverse Events;Quality of Life; | — |
Countries
China
Contacts
Public ContactWang Yan
Outcome results
None listed