Tarceva With or Without Apatinib in the Advanced Lung Adenocarcinoma

Phase 2

• Conditions: Lung Cancer
• Interventions: Drug: Apatinib; Drug: Tarceva; Drug: Placebo

• Registration Number: NCT02704767
• Lead Sponsor: First Affiliated Hospital of Kunming Medical University

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.

Study Timeline

• Study First Submitted: 2016-02-27
• Status Verified: 2016-03
• Study First Submitted QC: 2016-03-09
• Last Update Submitted: 2016-03-09
• Study First Posted: 2016-03-10
• Last Update Posted: 2016-03-10
• Study Start: 2016-06
• Primary Completion: 2019-06
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TarceA	Tarceva	Tarceva with Apatinib
TarceP	Placebo	Tarceva with Placebo
TarceP	Tarceva	Tarceva with Placebo
TarceA	Apatinib	Tarceva with Apatinib

Primary Outcome Measures

Name	Time	Method
Progression free survival	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	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 Outcome Measures

Name	Time	Method
Overall survival	From date of randomization until the date of death from any cause, assessed up to 36 months	From date of randomization until the date of death from any cause, assessed up to 36 months
Response rate	through study completion, an average of 1 year