Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 1:41 AM
NCT ID:
NCT03341494
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03341494
Study Brief:
Protocol Section:
NCT03341494