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

NCT03126799 | Unknown Phase 2

• 1 other identifier: NCC-2016-0107
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

EGFR Positive Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• PFS

  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 Outcomes (2)

• ORR

  through study completion, and average of 2 years

• OS

  From date of randomization until the date of death or date of last visit/contact, whichever came first, assessed to at least 36 months

Study Arms (2)

A: Erlotinib only

ACTIVE COMPARATOR

Standard therapy arm: Erlotinib 150mg. po, qd, daily, q 3weeks

Drug: Erlotinib

B: Erlotinib plus Bevacizumab

EXPERIMENTAL

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

Drug: Erlotinib plus Bevacizumab

Interventions

Erlotinib plus Bevacizumab DRUG

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

Also known as: Tarceva plus Avastin

B: Erlotinib plus Bevacizumab

Erlotinib DRUG

Erlotinib 150mg, po, daily, Q weeks

Also known as: Tarceva

A: Erlotinib only

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Center, Korea: lead
• Roche Korea co.,Ltd.: collaborator

Study Sites (1)

National Cancer Center

Goyang-si, Gyeonggi-do, 10408, South Korea

Location

Related Publications (1)

• 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.

  PMID: 33067126 DERIVED

MeSH Terms

Interventions

Erlotinib Hydrochloride; Bevacizumab

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Ji-Youn Han, Ph.D

  National Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Center for Lung Cancer

Study Record Dates

• First Submitted: March 30, 2017
• First Posted: April 24, 2017
• Study Start: November 1, 2016
• Primary Completion: December 31, 2021
• Study Completion: July 20, 2023
• Last Updated: April 6, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)