NCT03594682

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (estimated)
• Sponsor: Beijing Chest Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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).

Conditions

• NSCLC Stage IV
• NSCLC Stage IIIB

Interventions

Type	Name	Description
OTHER	Intervention/treatment	experimentalgroup initial dose： 1. 250mg qod 2. 250mg qd/500mg qd by turn 3. 500mg qd control group： 750mg qd

Timeline

• Start date: 2018-08-01
• Primary completion: 2019-07-01
• Completion: 2020-07-01
• First posted: 2018-07-20
• Last updated: 2018-07-20