EGFR-TKI With Chemotherapy in NSCLC Patients With Both EGFR Mutation and BIM Deletion Polymorphism
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ClinicalTrials.gov Identifier: NCT02859077 |
Recruitment Status : Unknown
Verified August 2016 by Caicun Zhou, Shanghai Pulmonary Hospital, Shanghai, China.
Recruitment status was: Not yet recruiting
First Posted : August 8, 2016
Last Update Posted : August 9, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non-Small-Cell Lung Cancer | Drug: EGFR-TKI Drug: Chemotherapy(pemetrexed/gemcitabine) Drug: Chemotherapy(carboplatin) | Phase 3 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: EGFR-TKI and Chemotherapy
NSCLC patients
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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 |
- Progress Free Survival [ Time Frame: 1 year ]
- Overall Response Rate [ Time Frame: 1 year ]
- Overall Survival [ Time Frame: 2 years ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02859077
Contact: Caicun Zhou, MD, PHD | +8613301825532 | caicunzhoudr@163.com | |
Contact: Yayi He, MD, PHD | +8613818828623 | doctorjael@qq.com |
Principal Investigator: | Caicun Zhou, MD, PHD | Shanghai Pulmonary Hospital, Tongji University |
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 Key Record Dates |
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. |
NSCLC BIM EGFR mutation |
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 |