Non-squamous non-small cell lung cancer
Conditions
Interventions
apatinib 250mg Qd:apatinib 250mg Qd combined with chemotherapy
apatinib 500mg Qd:apatinib 500mg Qd combined with chemotherapy
Sponsors
National Cancer Center/ 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) Patients with a histologic or cytologic diagnosis of non-squamous non-small cell lung cancer(including lung adenocarcinoma and large cell lung cancer); (2) Aged 18 to 80 years old; (3) The tumor is locally advanced or metastatic (Stage IIIB-IV), which is not suitable for radical surgery and 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) No primary anti-tumor treatment or develop progressive disease beyond TKI targeted therapy but had not received pemetrexed-based regimen chemotherapy; (7) Eastern Cooperative Oncology Group (ECOG) performance status (PS)=1; (8) 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); (9) Signed and dated informed consent. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.
Exclusion criteria
Exclusion criteria: (1) Patients with lung squamous cell carcinoma and lung adenosquamous carcinoma; (2) Patients with obvious lung cavity or necrotic tumor; (3) Significant hemoptysis and active hemorrhage, such as gastrointestinal bleeding, occurred within 2 months; (4) Treated with apatinib or pemetrexed-based regimen chemotherapy(except adjuvant chemotherapy after radical surgery); (5) Symptomatic brain metastases; (6) Accompanied by other malignant tumors or other active malignancies; (7) Function of important organs is incomplete; (8) 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; (9) Factors which may affect the clinical study and the results of the study through researchers'judgment.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| PFS;Drug safety;DCR;Qol; | — |
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Countries
China
Contacts
Public ContactWang Yan
National Cancer Center/ Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Outcome results
None listed