Conmana Combined With Thalidomide to Treat NSCLC

Phase 4

• Conditions: NSCLC
• Interventions: Drug: Conmana; Drug: Thalidomide

• Registration Number: NCT02778893
• Lead Sponsor: Henan Provincial People's Hospital

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.

Study Timeline

• Study Start: 2016-03
• Status Verified: 2016-05
• Study First Submitted: 2016-05-11
• Study First Submitted QC: 2016-05-18
• Last Update Submitted: 2016-05-18
• Study First Posted: 2016-05-20
• Last Update Posted: 2016-05-20
• Primary Completion: 2017-03
• Study Completion: 2020-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 67

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Conmana and Thalidomide	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.
Conmana and Thalidomide	Conmana	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

XZhang; 🇨🇳 Zhengzhou, Henan, China