Apatinib Plus Docetaxel as 2nd Line Treatment in Patients With Advanced Non-squamous and Non-small Cell Lung Cancer

Phase 2

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: Apatinib; Drug: Docetaxel

• Registration Number: NCT02780778
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Brief Summary

The purpose of this Phase II, Open-label, single arm, exploratory study is to evaluate the efficacy and the safety of Apatinib（500mg/d）with docetaxel (60 mg/m²) in advanced Non-squamous Non-small cell lung cancer after failure of first line chemotherapy.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-04
• Study Start: 2016-05
• Study First Submitted: 2016-05-03
• Study First Submitted QC: 2016-05-19
• Last Update Submitted: 2016-05-19
• Study First Posted: 2016-05-23
• Last Update Posted: 2016-05-23
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• ≥ 18 and ≤ 75 years of age
• Histologically or cytologic confirmed advanced non-squamous and non-small cell lung cancer.
• EGFR mutation testing negative of sensitive mutations
• At least one measurable lesion which has not received radiotherapy (larger than 10 mm in diameter by spiral CT scan)
• Have failed for 1 lines of chemotherapy
• ECOG performance scale 0 - 1.
• Life expectancy of more than 3 months.
• Duration from the last therapy is more than 6 weeks for nitroso or mitomycin
• More than 4 weeks after operation or radiotherapy
• More than 4 weeks for cytotoxic agents
• Adequate hepatic, renal, heart, and hematologic functions (hemoglobin ≥ 90g/L, platelets ≥ 80×10^9/L, neutrophils ≥ 1.5×10^9/L, total bilirubin within 1.25×the upper limit of normal(ULN), and serum transaminase≤2.5×the ULN (If liver metastases, serum transaminase≤5×the ULN), serum creatine ≤ 1.5 x ULN, creatinine clearance rate ≥ 50ml/min,
• Signed and dated informed consent.Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.

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Exclusion Criteria

• Received more than one kind of chemotherapy regimens
• NSCLC received other VEGFR inhibitors (except beacizumab) or docetaxel chemotherapy
• Existing therapy related toxicity of prior chemotherapy and/or radiation therapy
• Intercurrence with one of the following: hypertension, coronary artery disease, arrhythmia and heart failure
• Any factors that influence the usage of oral administration
• The center of the tumor invaded local large blood vessels
• Within 4 weeks before the first use of drugs, occurs pulmonary hemorrhage (≥ CTCAE class 2) or other parts' hemorrhage (≥ CTCAE class 3).
• Within 6 months before the first treatment occurs artery / venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism, etc.
• Less than 4 weeks from the last clinical trial

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment group	Apatinib	Apatinib：500 mg，po，qd； Docetaxel：60mg/m²，vein input 1hour，every 3w
Treatment group	Docetaxel	Apatinib：500 mg，po，qd； Docetaxel：60mg/m²，vein input 1hour，every 3w

Primary Outcome Measures

Name	Time	Method
progression-free survival	1 Day

Secondary Outcome Measures

Name	Time	Method
objective remission rate	1 Day
disease control rate	1 Day
Quality of life score	1 Day

Trial Locations

Locations (1)

Tianjin Medical University Cancer Institute and Hospital; 🇨🇳 Tianjin, Tianjin, China