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

• ClinicalTrials.gov Identifier: NCT02859077
• Recruitment Status: Unknown
• First Posted: August 8, 2016
• Last Update Posted: August 9, 2016
• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China
• Information provided by (Responsible Party): Caicun Zhou, Shanghai Pulmonary Hospital, Shanghai, China

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Non-Small-Cell Lung Cancer	Drug: EGFR-TKI; Drug: Chemotherapy（pemetrexed/gemcitabine）; Drug: Chemotherapy（carboplatin）	Phase 3

Detailed Description:

BIM deletion polymorphism was a poor clinical response marker to EGFR-TKIs in NSCLC patients who had EGFR mutations. In the study, the investigators want to use EGFR-TKI with chemotherapy as 1 st treatment in stage IIIB/IV NSCLC patients with both EGFR mutation and BIM deletion polymorphism.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: EGFR-TKI With Chemotherapy as First Line Treatment in Stage IIIB/IV NSCLC Patients With Both EGFR Mutation and BIM Deletion Polymorphism
• Study Start Date: August 2016
• Estimated Primary Completion Date: July 2017
• Estimated Study Completion Date: July 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: EGFR-TKI and Chemotherapy; NSCLC patients	Drug: EGFR-TKI; EGFR-TKI (gefitinib); Other Name: gefitinib; Drug: Chemotherapy（pemetrexed/gemcitabine）; Chemotherapy (pemetrexed/gemcitabine); Other Name: pemetrexed/gemcitabine; Drug: Chemotherapy（carboplatin）; Chemotherapy（carboplatin）; Other Name: carboplatin

Outcome Measures

Primary Outcome Measures :

1. Progress Free Survival [ Time Frame: 1 year ]

Secondary Outcome Measures :

1. Overall Response Rate [ Time Frame: 1 year ]
2. Overall Survival [ Time Frame: 2 years ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Contacts

Contact: Caicun Zhou, MD, PHD; +8613301825532; caicunzhoudr@163.com

Contact: Yayi He, MD, PHD; +8613818828623; doctorjael@qq.com

Sponsors and Collaborators

Shanghai Pulmonary Hospital, Shanghai, China

Investigators

• Principal Investigator: Caicun Zhou, MD, PHD; Shanghai Pulmonary Hospital, Tongji University

More Information

• Responsible Party: Caicun Zhou, Prof. Caicun Zhou, Shanghai Pulmonary Hospital, Shanghai, China
• ClinicalTrials.gov Identifier: NCT02859077
• Other Study ID Numbers: ShanghaiPH01
• First Posted: August 8, 2016
• Last Update Posted: August 9, 2016
• Last Verified: August 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: We will share the analysis data.

Keywords provided by Caicun Zhou, Shanghai Pulmonary Hospital, Shanghai, China:

NSCLC; BIM; EGFR mutation

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Gemcitabine; Carboplatin; Pemetrexed; Gefitinib; Antineoplastic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Antiviral Agents; Anti-Infective Agents; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors; Protein Kinase Inhibitors