Tarceva With or Without Apatinib in the Advanced Lung Adenocarcinoma

First Affiliated Hospital of Kunming Medical University

Status and phase: Unknown; Phase 2

Conditions: Lung Cancer

Treatments: Drug: Placebo; Drug: Tarceva; Drug: Apatinib

Study type: Interventional

Funder types: Other

Identifiers

NCT02704767

KMMURO001 (Other Identifier)

1stKunmingMC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

TarceP

Placebo Comparator group

Description:

Tarceva with Placebo

Treatment:

Drug: Placebo

Drug: Tarceva

TarceA

Experimental group

Description:

Tarceva with Apatinib

Treatment:

Drug: Apatinib

Drug: Tarceva