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

T

Tianjin Medical University

Status and phase

Unknown
Phase 3
Phase 2

Conditions

Non-small Cell Lung Cancer

Treatments

Drug: Docetaxel
Drug: Apatinib

Study type

Interventional

Funder types

Other

Identifiers

NCT02780778
AHEAD-HBL0001

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

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

Trial design

Primary purpose

Screening

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

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

Trial contacts and locations

1

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Central trial contact

Zhanyu Pan, Master

Data sourced from clinicaltrials.gov

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