EGFR Mutation Positive NSCLC Patients With Gefitinib and Thalidomide

NCT ID: NCT03341494

Last Updated: 2017-11-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-01
• Study Completion Date: 2020-11-01

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(PFS) could be expected when EGFR TKI, Gefitinib is combined with Antiangiogenesis agent thalidomide, Therefore Chinese data of treating EGFR mutation positive NSCLC patients with Gefitinib and thalidomide is significantly necessary for developing new standard treatment in first-line therapy in Chinese EGFR mutant NSCLC patients.

In this study, The investigators will investigate the efficacy and safety of Gefitinib and thalidomide combination compare to Gefitinib alone in Chinese EGFR-mutant NSCLC patients.

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(PFS) could be expected when EGFR TKI, Gefitinib is combined with Antiangiogenesis agent thalidomide, . Even Chinese and Japanese are classified as Asian based on location, the figure of Chinese is more tended to Western people due to the dietary life in recent years. However the incidence rate of EGFR mutation positive patients in Chinese is much higher than Western countries.

Therefore Chinese data of treating EGFR mutation positive NSCLC patients with Gefitinib and thalidomide is significantly necessary for developing new standard treatment in first-line therapy in Chinese EGFR mutant NSCLC patients.

In this study, The investigators will investigate the efficacy and safety of Gefitinib and thalidomide combination compare to Gefitinib alone in Chinese EGFR-mutant NSCLC patients.

Conditions

NSCLC Stage IV; Chemotherapy Effect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gefitinib 250mg qd thalidomide 200mg qn

Group Type: EXPERIMENTAL

Thalidomide

Intervention Type: DRUG

Gefitinib 250mg Thalidomide 200 MG

Gefitinib 250mg qd

Group Type: ACTIVE_COMPARATOR

Thalidomide

Intervention Type: DRUG

Gefitinib 250mg Thalidomide 200 MG

Interventions

Thalidomide

Gefitinib 250mg Thalidomide 200 MG

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gen lin

Role: PRINCIPAL_INVESTIGATOR

Fujian Cancer Hospital

Locations

Fujian Cancer Hospital Radiation Oncology Department

Fuzhou, Fujian, China

Site Status: RECRUITING

Fujian cancer hospital

Fuzhou, Fujian, China

Site Status: NOT_YET_RECRUITING

Countries

China

Central Contacts

wu zhuang, PhD

Role: CONTACT

Phone: 13809500871

Email: CSWOG001@163.com

Facility Contacts

wu zhuang, master

Role: primary

Gen Lin, MD

Role: primary

Other Identifiers

CSWOG002

Identifier Type: -

Identifier Source: org_study_id