Study of Anlotinib Plus Chemotherapy as the First-line Treatment in Patients With Advanced NSCLC

Inclusion Criteria:

• Age：18~70 years;

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 -2

• Subjects with histologically or cytologically confirmed locally advanced or advancedNSCLC

• EGFR\ALK\ROS1 wildtype or unknown,or patients with EGFR\ALK\ROS1 mutations but refuseto receive corresponding inhibitors' treatment

• No indications for radiation therapy

• Previously chemotherapy naive or postoperative adjuvant chemotherapy ended more than 1year

• Subjects with at least one measurable lesion as defined by RECIST (version 1.1),whichis confirmed by computed tomography (CT) scan or MRI

Exclusion Criteria:

• Small Cell Lung Cancer

• central lung squamous carcinoma along with cavum, or non-small cell lung cancer alongwith hemoptysis (>50ml/day)

• Within 30 days before enrollment, the patient had used any chemotherapy drugs in theprevious treatment regimen or clinical study; Or, within 14 days before the firstadministration of the study therapy, the patient has used any targeted anticancerdrugs in the previous treatment regimen or clinical study; Or stop other experimentaldrugs or cancer drugs for less than five half-life of the drug

• Previous use of anti-angiogenic drugs (such as anlotinib, apatinib, bevacizumab,endostar, etc.)

• have got non remissive toxic reactions derived from previous therapies, which is overlevel 1 in CTC AE (4.0), alopecia NOT included

• Spinal cord compression or symptomatic and untreated brain metastases (asymptomatic,stable, no need for steroid treatment for 4 weeks before study start)

• with kinds of factors which affect oral medicine (e.g. failing to swallow,gastrointestinal tract getting resected, chronic diarrhea and ileus)

• Previous histories include: interstitial pneumonia, drug-induced interstitialpneumonia, radiation pneumonia requiring steroid treatment, and clinically provenactive interstitial pneumonia

• get arterial/venous thrombosis within 6 months, such as cerebrovascular accidents (including temporary ischemic stoke), prevenous thrombosis, and pulmonary embolism

• Have suffered from hemorrhagic disease or coagulation dysfunction

• diagnosed with disease which will severely endanger the security of patients orinfluence the completion of this research