EGFR Mutation Positive NSCLC Patients With Gefitinib and Thalidomide

NCT03341494 | Unknown Phase 2 DMC

• 1 other identifier: CSWOG002
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 2

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.

Conditions

NSCLC Stage IV; Chemotherapy Effect

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)

Gefitinib 250mg qd thalidomide 200mg qn

EXPERIMENTAL

Drug: Thalidomide

Gefitinib 250mg qd

ACTIVE COMPARATOR

Drug: Thalidomide

Interventions

Thalidomide DRUG

Gefitinib 250mg Thalidomide 200 MG

Gefitinib 250mg qd; Gefitinib 250mg qd thalidomide 200mg qn

Eligibility Criteria

• Age: 18 Years - 70 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

• Fujian Cancer Hospital: lead

Study Sites (2)

Fujian Cancer Hospital Radiation Oncology Department

Fuzhou, Fujian, 350014, China

RECRUITING

Fujian cancer hospital

Fuzhou, Fujian, China

NOT YET RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Thalidomide

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Gen lin

  Fujian Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

wu zhuang, PhD

CONTACT

13809500871; CSWOG001@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2017
• First Posted: November 14, 2017
• Study Start: April 1, 2017
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2020
• Last Updated: November 14, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: yes
• Access Criteria: yes

Locations

CN (2)