Combination of Chemotherapy and Gefitinib as First-line Treatment
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ClinicalTrials.gov Identifier: NCT02148380 |
Recruitment Status :
Completed
First Posted : May 28, 2014
Last Update Posted : April 20, 2016
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Condition or disease | Intervention/treatment | Phase |
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Non-Small-Cell Lung Cancer | Drug: pemetrexed plus carboplatin Drug: gefitinib | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 121 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Combination of Chemotherapy and Gefitinib as First-line Treatment of Patients With Advanced Lung Adenocarcinoma and Sensitive EGFR Mutations: a Randomised Controlled Trial |
Study Start Date : | May 2014 |
Actual Primary Completion Date : | December 2014 |
Actual Study Completion Date : | December 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: chemotherapy group(B)
pemetrexed plus carboplatin pemetrexed (500 mg/m(2) on day 1) plus carboplatin (AUC 5 on day 1) every 4 weeks for up to six cycles, then continued to receive pemetrexed(500 mg/m(2) on day 1) alone every 4 weeks
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Drug: pemetrexed plus carboplatin
Other Name: Alimita plus carboplatin |
Experimental: combination therapy group(A)
pemetrexed (500 mg/m(2) on day 1) plus carboplatin (AUC 5 on day 1) combined with gefitinib (250 mg/day on days 5-21) and repeated every 4 weeks for up to six cycles,then continued to receive pemetrexed combined with gefitinib every 4 weeks.
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Drug: pemetrexed plus carboplatin
Other Name: Alimita plus carboplatin Drug: gefitinib Other Name: Iressa |
Experimental: gefitinib group (group C)
received gefitinib( 250 mg/day)alone. All therapies of 3 groups were continued until progression or unacceptable toxicity or death
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Drug: gefitinib
Other Name: Iressa |
- progression-free survival [ Time Frame: 6-month ]
- overall survival [ Time Frame: 2 years ]
- to evaluate the safety profile between three groups [ Time Frame: 6 months ]Toxicity will be graded according to NCI CTCAE, version 4.0. The analysis of safety/tolerability data will be descriptive; toxicity events will be individually tabulated.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 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)
- Measurable or non-measurable disease
- Able to comply with study and follow-up procedures
Exclusion Criteria:
- Evidence of small cell, carcinoid, or mixed small cell/non-small cell histology
- 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): NCT02148380
China | |
Shanghai Chest Hospital | |
Shanghai, China, 200030 |
Study Chair: | Baohui Han, Dr | Vice President of Shanghai Chest Hospital,Sponsor of study | |
Study Director: | Bo Jin, Dr | Study Leader,Doctor of Shanghai Chest Hospital | |
Principal Investigator: | Yanjie Niu, Master | Doctor of Shanghai Chest Hospital | |
Principal Investigator: | Yanwei Zhang, Dr | Doctor of Shanghai Chest Hospital | |
Principal Investigator: | Tianqing Chu, Dr | Doctor of Shanghai Chest Hospital | |
Principal Investigator: | Aiqin Gu, Master | Doctor of Shanghai Chest Hospital | |
Principal Investigator: | Lei Zhu, Master | Doctor of Shanghai Chest Hospital | |
Principal Investigator: | Jun Pei | Doctor of Shanghai Chest Hospital |
Responsible Party: | Baohui Han, the chief physician, Shanghai Chest Hospital |
ClinicalTrials.gov Identifier: | NCT02148380 |
Other Study ID Numbers: |
chest20140001 |
First Posted: | May 28, 2014 Key Record Dates |
Last Update Posted: | April 20, 2016 |
Last Verified: | April 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Lung adenocarcinoma,EGFR mutation, chemotherapy, gefitinib |
Carboplatin Pemetrexed Gefitinib Antineoplastic Agents Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors Protein Kinase Inhibitors |