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Report for Clinical Trial NCT03126799

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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.

NCT03126799 EGFR Positive Non-small Cell Lung Cancer
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma

2 Interventions

Name: Erlotinib plus Bevacizumab

Description: Erlotinib 150mg, po, daily, q 3weeks plus Bevacizumab 15mg/kg, IV, on D1 Q 3 weeks
Type: Drug
Group Labels: 1

B: Erlotinib plus Bevacizumab

Name: Erlotinib

Description: Erlotinib 150mg, po, daily, Q weeks
Type: Drug
Group Labels: 1

A: Erlotinib only


Primary Outcomes

Description: Progression Free Survival

Measure: PFS

Time: 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

Description: Overall Response Rate

Measure: ORR

Time: through study completion, and average of 2 years

Description: Overall Survival

Measure: OS

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

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 L858R

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. --- L858R ---

- 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 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. --- L858R ---



HPO Nodes


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