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

National Cancer Center (NCC)

Status and phase

Unknown

Phase 2

Conditions

EGFR Positive Non-small Cell Lung Cancer

Treatments

Drug: Erlotinib

Drug: Erlotinib plus Bevacizumab

Study type

Interventional

Funder types

Other

Identifiers

NCT03126799

NCC-2016-0107

Details and patient eligibility

About

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.

Full 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.

Enrollment

128 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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