Conmana Combined With Thalidomide to Treat NSCLC

May 18, 2016 updated by: XiaoJu Zhang, Henan Provincial People's Hospital

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)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

67

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: an yunxia
  • Phone Number: 15003866535

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Recruiting
        • XZhang
        • Contact:
          • zhang xiaoju
          • Phone Number: 15837101166
        • Principal Investigator:
          • zhang xiaoju

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Conmana and Thalidomide

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.
Drug: Conmana
125mg three times a day (TID) continuously
Other Names:
  • Icotinib
  • Icotinib Hydrochloride Tablets
Drug: Thalidomide
100mg one a day（QD）at night continuously,If can tolerance after 1 weeks to add to 200mg;
Other Names:
  • Thalomid
  • Sedoval
  • Celgene Brand of Thalidomide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henan Provincial People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Anticipated)

March 1, 2017

Study Completion (Anticipated)

March 1, 2020

Study Registration Dates

First Submitted

May 11, 2016

First Submitted That Met QC Criteria

May 18, 2016

First Posted (Estimate)

May 20, 2016

Study Record Updates

Last Update Posted (Estimate)

May 20, 2016

Last Update Submitted That Met QC Criteria

May 18, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICO-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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