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Optimizing the Therapeutic Dose of Apatinib Mesylate Tablets in Patients With Lung Cancer by Dose Titration：A Real World Exploratory Study

NSCLC Stage IV Clinical Trial

Official title:
Optimizing the Therapeutic Dose of Apatinib Mesylate Tablets in Patients With Lung Cancer by Dose Titration：A Real World Exploratory Study

Clinical Trial Summary

The purpose of the study is to evaluate the safety and efficacy of two different administration methods of apatinib in NSCLC patients.

Clinical Trial Description

1. Aged ≥18；

2. Locally advanced/metastatic non-small lung cancer (IIIb/IV) confirmed by pathology with measurable lesions；

3. Patients with wild type EGFR/ALK must received two kinds of systemic chemotherapy before；Patients with EGFR mutation positive had experienced treatment failure with TKI in first line and Chemotherapy in second line ；

4. ECOG：0-4；

5. The subjects were treated with other drugs has been restored (NCI CTCAE version 4.0 class 1 or less), which accept nitroso urea or mitomycin interval 6 weeks or more; Accept other cytotoxic drugs, bevacizumab (Avastin) (except local palliative radiotherapy), radiotherapy or surgery four weeks or more. EGFR TKI ≥2 weeks; Main organs function is normal；

6. Fertile woman must perform a pregnancy test (serum or urine) 7 days before screened, or voluntarily adopt proper methods of contraception during the observation period and 8 week after the last given apatinib. For man, surgical sterilization should be performed, or voluntarily adopt proper methods of contraception during the observation period and 8 week after the last given apatinib；

7. Patients voluntarily entered the study and signed informed consent form (ICF). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03594682
Study type Interventional
Source Beijing Chest Hospital
Contact Hu Ying
Phone 010-89509330
Email huying2004@126.com
Status Not yet recruiting
Phase N/A
Start date August 2018
Completion date July 2020
View Details
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