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

April 4, 2022 updated by: Ji-youn Han, National Cancer Center, Korea

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

128

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Goyang-Si, Gyeonggi-do, Korea, Republic of, 10408
        • National Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A: Erlotinib only

Standard therapy arm:

Erlotinib 150mg. po, qd, daily, q 3weeks
Drug: Erlotinib
Erlotinib 150mg, po, daily, Q weeks
Other Names:
  • 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 Names:
  • Tarceva plus Avastin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: through study completion, and average of 2 years
Overall Response Rate
through study completion, and average of 2 years
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
From date of randomization until the date of death or date of last visit/contact, whichever came first, assessed to at least 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Center, Korea

Collaborators

Roche Korea co.,Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

December 31, 2021

Study Completion (Anticipated)

July 20, 2023

Study Registration Dates

First Submitted

March 30, 2017

First Submitted That Met QC Criteria

April 19, 2017

First Posted (Actual)

April 24, 2017

Study Record Updates

Last Update Posted (Actual)

April 6, 2022

Last Update Submitted That Met QC Criteria

April 4, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCC-2016-0107

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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