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A Study of Tarceva vs. Avastin+Tarceva for Advanced NSCLC With EGFR m(+) (AvaTa)

This study is currently recruiting participants.
Verified April 2017 by Ji-youn Han, National Cancer Center, Korea
Sponsor:
ClinicalTrials.gov Identifier:
NCT03126799
First Posted: April 24, 2017
Last Update Posted: April 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Roche Korea co.,Ltd.
Information provided by (Responsible Party):
Ji-youn Han, National Cancer Center, Korea
  Purpose

Korean data of treating EGFR mutation positive NSCLC patients with Erlotinib and Bevacizumab is significantly necessary for developing new standard treatment in first-line therapy in Korean EGFR mutant NSCLC patients.

In this study, The investigators will investigate the efficacy and safety of Erlotinib and Bevacizumab combination compare to Erlotinib alone in Korean EGFR-mutant NSCLC patients.


Condition Intervention Phase
EGFR Positive Non-small Cell Lung Cancer Drug: Erlotinib plus Bevacizumab Drug: Erlotinib Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study of Erlotinib Alone Versus Erlotinib Plus Bevacizumab for Advanced Non-small Cell Lung Cancer With Epidermal Growth Factor Receptor Activating Mutations

Resource links provided by NLM:


Further study details as provided by Ji-youn Han, National Cancer Center, Korea:

Primary Outcome Measures:
  • PFS [ 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 at least 36 months. ]
    Progression Free Survival


Secondary Outcome Measures:
  • ORR [ Time Frame: through study completion, and average of 2 years ]
    Overall Response Rate

  • OS [ Time Frame: From date of randomization until the date of death or date of last visit/contact, whichever came first, assessed to at least 36 months ]
    Overall Survival


Estimated Enrollment: 128
Actual Study Start Date: November 1, 2016
Estimated Study Completion Date: December 31, 2020
Estimated Primary Completion Date: December 31, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A: Erlotinib only

Standard therapy arm:

Erlotinib 150mg. po, qd, daily, q 3weeks

Drug: Erlotinib
Erlotinib 150mg, po, daily, Q weeks
Other Name: Tarceva
Experimental: B: Erlotinib plus Bevacizumab
Study treatment arm; Erlotinib 150mg, po. qd, daily, q 3weeks plus Bevacizumab 15mg/kg, iv, on D1, q 3weeks.
Drug: Erlotinib plus Bevacizumab
Erlotinib 150mg, po, daily, q 3weeks plus Bevacizumab 15mg/kg, IV, on D1 Q 3 weeks
Other Name: Tarceva plus Avastin

Detailed Description:

EGFR-TKIs are the standard first-line treatment option for EGFR-mutant NSCLC. After a randomized phase II trial, JO25567 was presented at 2014 ASCO, the synergistic effect of progression-free survival(PFS) could be expected when EGFR TKI, Erlotinib is combined with Antiangiogenesis agent, Bevacizumab. Even Korean and Japanese are classified as Asian based on location, the figure of Korean is more tended to Western people due to the dietary life in recent years. However the incidence rate of EGFR mutation positive patients in Korea is much higher than Western countries.

Therefore Korean data of treating EGFR mutation positive NSCLC patients with Erlotinib and Bevacizumab is significantly necessary for developing new standard treatment in first-line therapy in Korean EGFR mutant NSCLC patients.

In this study, The investigators will investigate the efficacy and safety of Erlotinib and Bevacizumab combination compare to Erlotinib alone in Korean EGFR-mutant NSCLC patients.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically confirmed stage IIIB & IV non-small cell lung cancer other than squamous cell carcinoma
  • Patients with one or more measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
  • Locally diagnosed sensitive EGFR mutation positive (Exon 19 deletion or L858R)
  • ECOG performance 0~1
  • Age ≥ 19 years and - No previous treatment

Adequate organ function by following:

  • ANC ≥1,500/uL, hemoglobin ≥9.0g/dL, platelet ≥100,000/uL
  • Serum bilirubin < 1 x UNL, AST (SGOT) and ALT (SGPT) < 2.5 x UNL, If Liver metastasis, Serum bilirubin < 3 x UNL, AST (SGOT) and ALT (SGPT) < 5 x UNL
  • Serum Cr ≤ 1 x UNL
  • Patients who have had undergone radiotherapy are acceptable if patients meet all of the following criteria:

    • No history of irradiation to pulmonary tumor lesions.
    • In case of palliative irradiation to bone lesions in lung: at least 12 weeks must have passed at the date of registration since the last irradiation of the sites.
    • In case of irradiation to non-pulmonary sites: at least two weeks must have passed at the date of inclusion since the last irradiation of the sites
  • At the time of registration, at least the following period has passed since last date of the prior therapy or procedure:

    • Surgery(including exploratory/ examination thoracotomy): 4 weeks
    • Pleural cavity drainage: 1 weeks
    • Pleurodesis without anti-neoplastic agents (inclusive of BRM such as Picibanil): 2 week
    • Biopsy accompanied by incision (including thoracoscopic biopsy): 2 week
    • Procedure for trauma (exclusive of patients with unhealed wound): 2 weeks
    • Transfusion of blood, preparation of hematopoietic factor: 2 week
    • Puncture and aspiration cytology: 1 week
    • Other investigational product: 4 weeks
  • Written informed consent form

Exclusion Criteria:

  • Previous history of malignancy within 3 years from study entry except treated non-melanomatous skin cancer, uterine cervical cancer in situ, or thyroid cancer
  • Prior chemotherapy or systemic anti-cancer therapy for metastatic disease but postoperative adjuvant or neoadjuvant therapy of 6 months or more previously is allowed
  • Patients who received previous treatment for lung cancer with drugs
  • Symptomatic or uncontrolled central nervous system (CNS) metastases
  • Patients with increased risk of bleeding, clinically significant cardiovascular diseases, a history of thrombosis or thromboembolism in the 6 months prior to treatment, gastrointestinal problems, and neurologic problems
  • Any significant ophthalmologic abnormality
  • Pre-existing parenchymal lung disease such as pulmonary fibrosis
  • Known allergic history of Erlotinib or Bevacizumab
  • Interstitial lung disease or fibrosis on chest radiogram
  • Active infection, uncontrolled systemic disease (cardiopulmonary insufficiency, fatal arrhythmias, hepatitis)
  • Pregnant or nursing women
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03126799


Contacts
Contact: Ji-Youn Han, Ph.D +82-31-920-1154 jymama@ncc.re.kr
Contact: Sung Jin Yoon 82-31-920-0399 sjyoon@ncc.re.kr

Locations
Korea, Republic of
National Cancer Center Recruiting
Goyang-Si, Gyeonggi-do, Korea, Republic of, 10408
Contact: Ji-Youn Han, Ph.D    +82-31-920-1210    jymama@ncc.re.kr   
Contact: Sung Jin Yoon    +82-31-920-0399    sjyoon@ncc.re.kr   
Sponsors and Collaborators
National Cancer Center, Korea
Roche Korea co.,Ltd.
Investigators
Principal Investigator: Ji-Youn Han, Ph.D National Cancer Center
  More Information

Responsible Party: Ji-youn Han, Head of Center for Lung Cancer, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT03126799     History of Changes
Other Study ID Numbers: NCC-2016-0107
First Submitted: March 30, 2017
First Posted: April 24, 2017
Last Update Posted: April 24, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Bronchial Neoplasms
Erlotinib Hydrochloride
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action