Clinical trial NCT02704767: Tarceva With or Without Apatinib in the Advanced Lung Adenocarcinoma
Official title: Tarceva With or Without Apatinib in the First-line Therapy of Advanced Lung Adenocarcinoma With Mutant EGFR:a Phase II Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lung Cancer
Lead sponsor: First Affiliated Hospital of Kunming Medical University
Sponsor class: OTHER
First posted: 2016-03-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Tarceva now was established first-line therapy for advanced lung adenocarcinoma with mutant EGFR patients.However,the benefit lasted for about 6-8 months.So we consider to add apatinib,a tyrosine kinase inhibitor of VEGF,to the therapy of these patients.

Detailed description: Lung adenocarcinoma is the most common NSCLC,most patient were diagnosed to advanced stage.The first-line therapy include chemotherapy of targeted therapy .Tarceva now was established first-line therapy for advanced lung adenocarcinoma with mutant EGFR patients.However,the benefit lasted for about 6-8 months.So we consider to add apatinib,a tyrosine kinase inhibitor of VEGF,to the therapy of these patients.We designed the study to find out whether the addition of apatinib to the Tarceva would enhance the efficacy of Tarceva.

Eligibility criteria: Inclusion Criteria:

* lung adenocarcinoma proved by histology;with mutant EGFR;ECOG PS 0-2;Clinical stage IIIb or IV;without other fatal disease;without hemorrhagic disease;normal liver,renal and bone marrow function,not pregnant.

Exclusion Criteria:

* ECOG PS 3-5;abnormal liver,renal and bone marrow function,pregnant;with severe diseases;wild type EGFR

Primary outcomes:
measure: Progression free survival
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Secondary outcomes:
measure: Overall survival
timeFrame: From date of randomization until the date of death from any cause, assessed up to 36 months
measure: Response rate
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
Study officials:
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