Gefitinib Combined With Thalidomide to Treat NSCLC

NCT02387086 | Unknown Phase 2 DMC

• 1 other identifier: GELI
• Study Type: interventional
• Target: 380
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine whether thalidomide can improve the effectiveness of the gefitinib in NSCLC patients with EGFR mutations.

Conditions

NSCLC

Keywords

gefitinib; thalidomide; NSCLC; EGFR mutation

Outcome Measures

Primary Outcomes (1)

• progression-free survival (PFS)

  one year progression-free survival of the patients

  1 year

Secondary Outcomes (2)

• Objective Response Rate (ORR)

  2 years

• Overall Survival (OS)

  2 years

Other Outcomes (1)

• IL-2 level

  2 years

Study Arms (2)

A:gefitinib and thalidomide/aspirin

EXPERIMENTAL

intervention: drug: gefitinib and thalidomide/aspirin: gefitinib will be administered at 250mg QD continuously; thalidomide will be administered at 100mg QD at night continuously; aspirin will be administered at 100mg QD continuously;

Drug: Thalidomide; Drug: Gefitinib; Drug: Aspirin

B:Placebo

PLACEBO COMPARATOR

intervention: drug: gefitinib and placebo/aspirin: gefitinib will be administered at 250mg QD continuously; placebo will be given to patients in the same way as the thalidomide; aspirin will be administered at 100mg QD continuously;

Drug: placebo; Drug: Gefitinib; Drug: Aspirin

Interventions

Thalidomide DRUG

A:gefitinib and thalidomide/aspirin

placebo DRUG

B:Placebo

Gefitinib DRUG

A:gefitinib and thalidomide/aspirin; B:Placebo

Aspirin DRUG

A:gefitinib and thalidomide/aspirin; B:Placebo

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 be NSCLC confirmed by Histological or cytological;
• The NSCLC harbors EGFR-mutation and are previously untreated
• Patient must have measurable lesion and in stage IIIB or IV disease (includes M1a, M1b stages or recurrent disease) (according to the 7th edition of the tumor node metastasis (TNM) classification system).
• Patients be age \>18 years and \< 75 years.
• Patients must have a Life Expectancy of greater than 12 weeks.
• Patients must have an ECOG performance status 0 to 2.
• Patients must have normal organ and marrow function as defined below, within one week prior to randomization: absolute neutrophil count\>1,500/mL platelets\>100,000/mL total bilirubin: within normal institutional limits AST/ALT\<2.5X institutional upper limit of normal creatinine≤1.5X 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.
• Patients must have an international normalized ratio (INR) \< 1.5 and a partial thromboplastin time (PTT) no greater than upper limits of normal within 1 week prior to randomization.
• Patients with a history of hypertension must be well-controlled (\<150 systolic/\<100 diastolic) on a stable regimen of anti-hypertensive therapy.
• Patients must be able to swallow tablets.
• Patients must have the ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Patients with uncontrolled illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements.
• Patients receiving therapeutic anticoagulation. Prophylactic anticoagulation of venous access devices is allowed provided Section 3.10 is met. Caution should be taken on treating patients with low dose heparin or low molecular weight heparin for DVT prophylaxis during treatment with bevacizumab as there may be an increased risk of bleeding.
• Patients cannot administer aspirin for the risk of bleeding or having stomach ulcers.
• Prior use of chemotherapy.
• Patients receiving immunotherapy, hormonal-therapy and or radiotherapy within 2 weeks prior to entering the study. Note: Those who have not recovered from adverse events due to these agents administered will be considered ineligible.
• Patients receiving any other investigational agents.
• Patients with uncontrolled brain metastasis. Note: Patients with brain metastases must have stable neurologic status following local therapy (surgery or radiation) for at least 2 weeks, and must be without neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
• Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to thalidomide、gefitinib and aspirin or other agents used in the study are excluded.
• 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.
• HIV-positive Patients that are on combination antiretroviral therapy due to the potential for lethal infections when treated with marrow-suppressive therapy.

Sponsors & Collaborators

• Bai Jun: lead

MeSH Terms

Interventions

Thalidomide; Gefitinib; Aspirin

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; Quinazolines; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Jun Bai

  Shaanxi Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Bai

CONTACT

+86-13186055863; baijun@yahoo.com

Yu Lei

CONTACT

+86-18682984013; leiyu1981@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: March 3, 2015
• First Posted: March 12, 2015
• Study Start: May 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: March 12, 2015

Record last verified: 2015-03