EGFR-TKI With/Without Chemotherapy in NSCLC Patients With Both EGFR Mutation and BIM Deletion Polymorphism

NCT03002844 | Unknown Phase 2 DMC

• 1 other identifier: ShanghaiPH002
• Study Type: interventional
• Target: 50
• 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/without chemotherapy as first line treatment in stage IIIB/IV NSCLC patients with both EGFR mutation and BIM deletion polymorphism.

Conditions

Nonsmall Cell Lung Cancer; EGFR Gene Mutation

Outcome Measures

Primary Outcomes (1)

• Progress Free Survival

  up to 12 months

Secondary Outcomes (3)

• Overall Survival

  up to 24 months

• Overall Response Rate

  up to 12 months

• Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0

  up to 12 months

Study Arms (2)

EGFR-TKI and Chemotherapy

EXPERIMENTAL

gefitinib with pemetrexed/gemcitabine and carboplatin

Drug: EGFR-TKI; Drug: EGFR-TKI and Chemotherapy

EGFR-TK Inhibitor

EXPERIMENTAL

Gefitinib

Drug: EGFR-TK Inhibitor

Interventions

EGFR-TK Inhibitor DRUG

EGFR-TKI (gefitinib 250mg per day)

Also known as: gefitinib

EGFR-TK Inhibitor

EGFR-TKI DRUG

EGFR-TKI (gefitinib 250mg per day)

Also known as: gefitinib

EGFR-TKI and Chemotherapy

EGFR-TKI and Chemotherapy DRUG

pemetrexed 500mg per kg q3w/gemcitabine 1000mg per kg q3w and carboplatin AUC=5 q3w

Also known as: EGFR-TKI and pemetrexed/gemcitabine and 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
• Histologically documented, unresectable, inoperable, locally advanced, recurrent or metastatic Stage IV Non-Small Cell Lung Cancer (NSCLC)
• 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
• 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; Drug Therapy; Pemetrexed; Gemcitabine; 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; Therapeutics; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; 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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Head of Medical Oncology, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: December 14, 2016
• First Posted: December 26, 2016
• Study Start: December 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: December 1, 2018
• Last Updated: December 28, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share