Status:
UNKNOWN
EGFR Mutation Positive NSCLC Patients With Gefitinib and Thalidomide
Lead Sponsor:
Fujian Cancer Hospital
Conditions:
NSCLC Stage IV
Chemotherapy Effect
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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...
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...
Eligibility Criteria
Inclusion
- 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
- • 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
Key Trial Info
Start Date :
April 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2020
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT03341494
Start Date
April 1 2017
End Date
November 1 2020
Last Update
November 14 2017
Active Locations (2)
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1
Fujian Cancer Hospital Radiation Oncology Department
Fuzhou, Fujian, China, 350014
2
Fujian cancer hospital
Fuzhou, Fujian, China