EGFR-TKI With Chemotherapy in NSCLC Patients With Both EGFR Mutation and BIM Deletion Polymorphism

NCT02859077 | Unknown Phase 3 DMC

• 1 other identifier: ShanghaiPH01
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

BIM deletion polymorphism might be associated with a poor clinical response to EGFR-TKIs in patients who had NSCLC with EGFR mutations. In the study, the investigators want to use EGFR-TKI with chemotherapy as first line treatment in stage IIIB/IV NSCLC patients with both EGFR mutation and BIM deletion polymorphism.

Conditions

Non-Small-Cell Lung Cancer

Keywords

NSCLC; BIM; EGFR mutation

Outcome Measures

Primary Outcomes (1)

• Progress Free Survival

  1 year

Secondary Outcomes (2)

• Overall Response Rate

  1 year

• Overall Survival

  2 years

Study Arms (1)

EGFR-TKI and Chemotherapy

EXPERIMENTAL

NSCLC patients

Drug: EGFR-TKI; Drug: Chemotherapy（pemetrexed/gemcitabine）; Drug: Chemotherapy（carboplatin）

Interventions

EGFR-TKI DRUG

EGFR-TKI (gefitinib)

Also known as: gefitinib

EGFR-TKI and Chemotherapy

Chemotherapy（pemetrexed/gemcitabine） DRUG

Chemotherapy (pemetrexed/gemcitabine)

Also known as: pemetrexed/gemcitabine

EGFR-TKI and Chemotherapy

Chemotherapy（carboplatin） DRUG

Chemotherapy（carboplatin）

Also known as: carboplatin

EGFR-TKI and Chemotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent Age \>=18 years Histologically documented, unresectable, inoperable, locally advanced, recurrent or metastatic Stage IV Non-Small Cell Lung Cancer (NSCLC) A cytologic diagnosis is acceptable (i.e., FNA or pleural fluid cytology) Must have measurable or non-measurable disease Must be able to comply with study and follow-up procedures

You may not qualify if:

• Small cell, carcinoid, or mixed small cell lung cancer Malignancies within 3 years except for adequately treated carcinoma in situ of -the cervix or basal or squamous cell skin cancer Symptomatic or untreated brain metastases Prior systemic chemotherapy for NSCLC Unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months prior to Day 1, or serious cardiac arrhythmia requiring medication (patients with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia, are eligible) History of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the patient at high risk from treatment complications Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation, or prior surgical procedures affecting absorption Pregnancy or lactation

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Gefitinib; Gemcitabine; Pemetrexed; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Coordination Complexes; Organic Chemicals

Study Officials

• Caicun Zhou, MD, PHD

  Shanghai Pulmonary Hospital, Tongji University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caicun Zhou, MD, PHD

CONTACT

+8613301825532; caicunzhoudr@163.com

Yayi He, MD, PHD

CONTACT

+8613818828623; doctorjael@qq.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Caicun Zhou

Study Record Dates

• First Submitted: July 31, 2016
• First Posted: August 8, 2016
• Study Start: August 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2018
• Last Updated: August 9, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will share