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Conmana Combined With Thalidomide to Treat NSCLC

Primary Purpose

NSCLC

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Conmana
Thalidomide
Sponsored by
Henan Provincial People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NSCLC focused on measuring Conmana, Thalidomide, NSCLC, EGFR mutation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients must have the ability to understand and the willingness to sign a written informed consent document.
  2. Patients be age >18 years and < 75 years. Patients must have a Life Expectancy of greater than 3 months.
  3. Patients must be NSCLC confirmed by Histological or cytological.
  4. Eastern Cooperative Oncology Group (ECOG) score standard: 0-2.
  5. Patients must have normal organ and marrow function as defined below, within two week prior to study: absolute neutrophil count>1,500/mL platelets>100,000/mL total bilirubin: within normal institutional limits Aspartate transaminase (AST)/Alanine aminotransferase (ALT) <2.5 times institutional upper limit of normal creatinine≤1.5 times institutional upper limit of normal urine dipstick for proteinuria of < less than 1+. If urine dipstick is > 1+ then a 24 hour urine for protein must demonstrate <500mg of protein in 24 hours to allow participation in the study.
  6. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  7. Judging by the researchers, that patients can comply with the program.

Exclusion Criteria:

  1. Women that are pregnant or breastfeeding Note: Pregnant women are excluded from this study because the agents used in this study may be teratogenic to a fetus. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with thalidomide, breastfeeding women are also excluded from this study.
  2. During the course of the treatment, the serious active infection of intravenous injection of antibiotics is required.
  3. Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to thalidomide and icotinib or other agents used in the study are excluded.
  4. A person who is not effectively controlled, has symptoms of brain metastases, or suffers from a mental disorder that is not easily controlled; has a severe mental or cognitive impairment.
  5. Congestive heart failure, arrhythmia, myocardial infarction, unstable angina, stroke or transient ischemic attack in 6 months.
  6. 5 years of suffering from other malignancies, except for the treatment of cervical carcinoma in situ or skin squamous cell carcinoma of the skin, or the basic control of skin basal cell carcinoma.
  7. Can not follow the test program or can not meet the follow-up of patients.
  8. The researchers think it is not appropriate to participate in this trial.

Sites / Locations

  • XZhangRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Conmana and Thalidomide

Arm Description

Conmana(Icotinib Hydrochloride Tablets) and Thalidomide: Conmana(Icotinib Hydrochloride Tablets) will be administered at 125mg three times a day(TID)continuously; Thalidomide will be administered at 100mg one a day(QD)at night continuously,If can tolerance after 1 weeks to add to 200mg.

Outcomes

Primary Outcome Measures

5 years the progression-free survival (PFS) rate of the combination of thalidomide with gefitinib in patients who harbors EGFR mutations.

Secondary Outcome Measures

Full Information

First Posted
May 11, 2016
Last Updated
May 18, 2016
Sponsor
Henan Provincial People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02778893
Brief Title
Conmana Combined With Thalidomide to Treat NSCLC
Official Title
A Phase Ⅳ,Open,Multicenter,Single Arm Study to Evaluate the Efficacy of the Combination Conmana With Thalidomide in Patients With NSCLC(Non-Small-Cell-Lung-Cancer)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
March 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henan Provincial People's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Our study the NSCLC harbors EGFR-mutation with Conmana combined with thalidomide as first-line treatment, is expected to improve further EGFR-Tyrosine kinase inhibitors (TKI) response rate (ORR), prolong time to progression (PFS), improve patient survival.
Detailed Description
Primary Objective: To evaluate the efficacy, survival and side effects of the combined therapy, and to evaluate the effectiveness and safety of thalidomide with Conmana in patients who harbors EGFR mutations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NSCLC
Keywords
Conmana, Thalidomide, NSCLC, EGFR mutation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Allocation
N/A
Enrollment
67 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conmana and Thalidomide
Arm Type
Experimental
Arm Description
Conmana(Icotinib Hydrochloride Tablets) and Thalidomide: Conmana(Icotinib Hydrochloride Tablets) will be administered at 125mg three times a day(TID)continuously; Thalidomide will be administered at 100mg one a day(QD)at night continuously,If can tolerance after 1 weeks to add to 200mg.
Intervention Type
Drug
Intervention Name(s)
Conmana
Other Intervention Name(s)
Icotinib, Icotinib Hydrochloride Tablets
Intervention Description
125mg three times a day (TID) continuously
Intervention Type
Drug
Intervention Name(s)
Thalidomide
Other Intervention Name(s)
Sedoval, Thalomid, Celgene Brand of Thalidomide
Intervention Description
100mg one a day(QD)at night continuously,If can tolerance after 1 weeks to add to 200mg;
Primary Outcome Measure Information:
Title
5 years the progression-free survival (PFS) rate of the combination of thalidomide with gefitinib in patients who harbors EGFR mutations.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must have the ability to understand and the willingness to sign a written informed consent document. Patients be age >18 years and < 75 years. Patients must have a Life Expectancy of greater than 3 months. Patients must be NSCLC confirmed by Histological or cytological. Eastern Cooperative Oncology Group (ECOG) score standard: 0-2. Patients must have normal organ and marrow function as defined below, within two week prior to study: absolute neutrophil count>1,500/mL platelets>100,000/mL total bilirubin: within normal institutional limits Aspartate transaminase (AST)/Alanine aminotransferase (ALT) <2.5 times institutional upper limit of normal creatinine≤1.5 times institutional upper limit of normal urine dipstick for proteinuria of < less than 1+. If urine dipstick is > 1+ then a 24 hour urine for protein must demonstrate <500mg of protein in 24 hours to allow participation in the study. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Judging by the researchers, that patients can comply with the program. Exclusion Criteria: Women that are pregnant or breastfeeding Note: Pregnant women are excluded from this study because the agents used in this study may be teratogenic to a fetus. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with thalidomide, breastfeeding women are also excluded from this study. During the course of the treatment, the serious active infection of intravenous injection of antibiotics is required. Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to thalidomide and icotinib or other agents used in the study are excluded. A person who is not effectively controlled, has symptoms of brain metastases, or suffers from a mental disorder that is not easily controlled; has a severe mental or cognitive impairment. Congestive heart failure, arrhythmia, myocardial infarction, unstable angina, stroke or transient ischemic attack in 6 months. 5 years of suffering from other malignancies, except for the treatment of cervical carcinoma in situ or skin squamous cell carcinoma of the skin, or the basic control of skin basal cell carcinoma. Can not follow the test program or can not meet the follow-up of patients. The researchers think it is not appropriate to participate in this trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
zhang xiaoju
Phone
15837101166
Email
15837101166@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
an yunxia
Phone
15003866535
Facility Information:
Facility Name
XZhang
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zhang xiaoju
Phone
15837101166
First Name & Middle Initial & Last Name & Degree
zhang xiaoju

12. IPD Sharing Statement

Plan to Share IPD
Yes

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Conmana Combined With Thalidomide to Treat NSCLC

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