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

NCT ID: NCT03126799

Last Updated: 2022-04-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-01
• Study Completion Date: 2023-07-20

Brief Summary

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.

Conditions

EGFR Positive Non-small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A: Erlotinib only

Standard therapy arm:

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

Group Type: ACTIVE_COMPARATOR

Erlotinib

Intervention Type: DRUG

Erlotinib 150mg, po, daily, Q weeks

B: Erlotinib plus Bevacizumab

Study treatment arm; Erlotinib 150mg, po. qd, daily, q 3weeks plus Bevacizumab 15mg/kg, iv, on D1, q 3weeks.

Group Type: EXPERIMENTAL

Erlotinib plus Bevacizumab

Intervention Type: DRUG

Erlotinib 150mg, po, daily, q 3weeks plus Bevacizumab 15mg/kg, IV, on D1 Q 3 weeks

Interventions

Erlotinib plus Bevacizumab

Erlotinib 150mg, po, daily, q 3weeks plus Bevacizumab 15mg/kg, IV, on D1 Q 3 weeks

Intervention Type: DRUG

Erlotinib

Erlotinib 150mg, po, daily, Q weeks

Intervention Type: DRUG

Other Intervention Names

Tarceva plus Avastin; Tarceva

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roche Korea co.,Ltd.

UNKNOWN

Sponsor Role: collaborator

National Cancer Center, Korea

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ji-youn Han

Head of Center for Lung Cancer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ji-Youn Han, Ph.D

Role: PRINCIPAL_INVESTIGATOR

National Cancer Center

Locations

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Countries

South Korea

References

Deng Z, Qin Y, Liu Y, Zhang Y, Lu Y. Role of Antiangiogenic Agents Combined With EGFR Tyrosine Kinase Inhibitors in Treatment-naive Lung Cancer: A Meta-Analysis. Clin Lung Cancer. 2021 Jan;22(1):e70-e83. doi: 10.1016/j.cllc.2020.08.005. Epub 2020 Sep 18.

Reference Type: DERIVED

PMID: 33067126 (View on PubMed)

Other Identifiers

NCC-2016-0107

Identifier Type: -

Identifier Source: org_study_id