Conmana Combined With Thalidomide to Treat NSCLC

NCT02778893 | Unknown Phase 4 DMC

• 1 other identifier: ICO-01
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

NSCLC

Keywords

Conmana; Thalidomide; NSCLC; EGFR mutation

Outcome Measures

Primary Outcomes (1)

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

  5 years

Study Arms (1)

Conmana and Thalidomide

EXPERIMENTAL

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; Drug: Thalidomide

Interventions

Conmana DRUG

125mg three times a day (TID) continuously

Also known as: Icotinib, Icotinib Hydrochloride Tablets

Conmana and Thalidomide

Thalidomide DRUG

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

Also known as: Sedoval, Thalomid, Celgene Brand of Thalidomide

Conmana and Thalidomide

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Henan Provincial People's Hospital: lead

Study Sites (1)

XZhang

Zhengzhou, Henan, 450000, China

RECRUITING

MeSH Terms

Interventions

icotinib; Thalidomide

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

Central Study Contacts

zhang xiaoju

CONTACT

15837101166; 15837101166@163.com

an yunxia

CONTACT

15003866535

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: May 11, 2016
• First Posted: May 20, 2016
• Study Start: March 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2020
• Last Updated: May 20, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)