EGFR Mutation Positive NSCLC Patients With Gefitinib and Thalidomide

A Randomized Phase II Study of Gefitinib Alone Versus Gefitinib Plus Thalidomide for Advanced Non-small Cell Lung Cancer With Epidermal Growth Factor Receptor Activating Mutations

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.

Study Overview

• Status: Unknown
• Conditions: Chemotherapy Effect; NSCLC Stage IV
• Intervention / Treatment: Drug: Thalidomide

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.

• Study Type: Interventional
• Enrollment (Anticipated): 128
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China
      • Not yet recruiting
      • Fujian Cancer Hospital
      • Contact: Gen Lin, MD; Phone Number: 0086-591-83660063
    • Fuzhou, Fujian, China, 350014
      • Recruiting
      • Fujian Cancer Hospital Radiation Oncology Department
      • Contact: wu zhuang, master; Phone Number: 0086-02083660063; Email: fjthkjk@sohu.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gefitinib 250mg qd thalidomide 200mg qn	Drug: Thalidomide; Gefitinib 250mg Thalidomide 200 MG
Active Comparator: Gefitinib 250mg qd	Drug: Thalidomide; Gefitinib 250mg Thalidomide 200 MG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	Overall Response Rate	through study completion, and average of 2 years
OS	Overall Survival	From date of randomization until the date of death or date of last visit/contact, whichever came first, assessed to at least 36 months

Collaborators and Investigators

• Sponsor: Fujian Cancer Hospital
• Investigators: Principal Investigator: Gen lin, Fujian Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Anticipated): November 1, 2019
• Study Completion (Anticipated): November 1, 2020

Study Registration Dates

• First Submitted: November 6, 2017
• First Submitted That Met QC Criteria: November 12, 2017
• First Posted (Actual): November 14, 2017

Study Record Updates

• Last Update Posted (Actual): November 14, 2017
• Last Update Submitted That Met QC Criteria: November 12, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Anti-Bacterial Agents; Leprostatic Agents; Thalidomide
• Other Study ID Numbers: CSWOG002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: yes
• IPD Sharing Time Frame: yes
• IPD Sharing Access Criteria: yes
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No