Clinical Trials /

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

NCT03126799

Description:

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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of Tarceva vs. Avastin+Tarceva for Advanced NSCLC With EGFR m(+)
  • 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

Clinical Trial IDs

  • ORG STUDY ID: NCC-2016-0107
  • NCT ID: NCT03126799

Conditions

  • EGFR Positive Non-small Cell Lung Cancer

Interventions

DrugSynonymsArms
Erlotinib plus BevacizumabTarceva plus AvastinB: Erlotinib plus Bevacizumab
ErlotinibTarcevaA: Erlotinib only

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.

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.
    

Trial Arms

NameTypeDescriptionInterventions
A: Erlotinib onlyActive ComparatorStandard therapy arm: Erlotinib 150mg. po, qd, daily, q 3weeks
  • Erlotinib
B: Erlotinib plus BevacizumabExperimentalStudy treatment arm; Erlotinib 150mg, po. qd, daily, q 3weeks plus Bevacizumab 15mg/kg, iv, on D1, q 3weeks.
  • Erlotinib plus Bevacizumab

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:19 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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.
Safety Issue:
Description:Progression Free Survival

Secondary Outcome Measures

Measure:ORR
Time Frame:through study completion, and average of 2 years
Safety Issue:
Description:Overall Response Rate
Measure: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
Safety Issue:
Description:Overall Survival

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:National Cancer Center, Korea

Last Updated

April 19, 2017