Conmana Combined With Thalidomide to Treat NSCLC

NCT ID: NCT02778893

Last Updated: 2016-05-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2020-03-31

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.

Conditions

NSCLC

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT

Study Groups

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.

Group Type: EXPERIMENTAL

Conmana

Intervention Type: DRUG

125mg three times a day (TID) continuously

Thalidomide

Intervention Type: DRUG

100mg one a day（QD）at night continuously,If can tolerance after 1 weeks to add to 200mg;

Interventions

Conmana

125mg three times a day (TID) continuously

Intervention Type: DRUG

Thalidomide

100mg one a day（QD）at night continuously,If can tolerance after 1 weeks to add to 200mg;

Intervention Type: DRUG

Other Intervention Names

Icotinib; Icotinib Hydrochloride Tablets; Sedoval; Thalomid; Celgene Brand of Thalidomide

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henan Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

XiaoJu Zhang

Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

XZhang

Zhengzhou, Henan, China

Site Status: RECRUITING

Countries

China

Central Contacts

zhang xiaoju

Role: CONTACT

15837101166@163.com

15837101166

an yunxia

Role: CONTACT

15003866535

Facility Contacts

zhang xiaoju

Role: primary

15837101166

Other Identifiers

ICO-01

Identifier Type: -

Identifier Source: org_study_id