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Tarceva With or Without Apatinib in the Advanced Lung Adenocarcinoma

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ClinicalTrials.gov Identifier: NCT02704767
Recruitment Status : Not yet recruiting
First Posted : March 10, 2016
Last Update Posted : March 10, 2016
Sponsor:
Information provided by (Responsible Party):
Li Rong-qing, The First Affiliated Hospital of Kunming Medical College

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: Apatinib Drug: Tarceva Drug: Placebo Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Tarceva With or Without Apatinib in the First-line Therapy of Advanced Lung Adenocarcinoma With Mutant EGFR:a Phase II Study.
Study Start Date : June 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: TarceP
Tarceva with Placebo
Drug: Tarceva
Drug: Placebo
Experimental: TarceA
Tarceva with Apatinib
Drug: Apatinib
a tyrosine kinase inhibitor of VEGF invented by Hengrui pharma in China
Other Name: AiTan

Drug: Tarceva



Primary Outcome Measures :
  1. Progression free survival [ Time Frame: 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 :
  1. Overall survival [ Time Frame: 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

  2. Response rate [ Time Frame: through study completion, an average of 1 year ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Additional Information:
Publications:
Qin S. Phase III study of apatinib in advanced gastric cancer: a randomized, double-blind, placebo-controlled trial. J Clin Oncol. 2014; 32(Suppl):Abst 4003.
Zhang L, Shi M, Huang C, et al. A phase II, multicenter, placebo-controlled trial of apatinib in patients with advanced nonsquamous non-small cell lung cancer (NSCLC) after two previous treatment regimens. J Clin Oncol. 2012;30(Suppl):Abst 7548.

Responsible Party: Li Rong-qing, Professor, The First Affiliated Hospital of Kunming Medical College
ClinicalTrials.gov Identifier: NCT02704767     History of Changes
Other Study ID Numbers: 1stKunmingMC
KMMURO001 ( Other Identifier: 1stKunmingMU )
First Posted: March 10, 2016    Key Record Dates
Last Update Posted: March 10, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action