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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
Sponsor:
Information provided by (Responsible Party):
Baohui Han, Shanghai Chest Hospital

Brief Summary:
The results of fastact2 show that chemotherapy plus erlotinib significantly prolonged PFS and OS of patients with NSCLC. However, outcome of the combination therapy are similar to those reported in several trials of single-agent EGFR TKIs. So which is the optimal first-line treatment for patients who harbored a sensitive EGFR mutation? The investigators need a head-to-head study to reply.

Condition or disease Intervention/treatment Phase
Non-Small-Cell Lung Cancer Drug: pemetrexed plus carboplatin Drug: gefitinib Not Applicable

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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

Resource links provided by the National Library of Medicine


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
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.
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
Drug: gefitinib
Other Name: Iressa




Primary Outcome Measures :
  1. progression-free survival [ Time Frame: 6-month ]

Secondary Outcome Measures :
  1. overall survival [ Time Frame: 2 years ]
  2. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed informed consent
  2. Age >=18 years
  3. Histologically documented, unresectable, inoperable, locally advanced, recurrent or metastatic Stage IV Non-Small Cell Lung Cancer (NSCLC)
  4. A cytologic diagnosis is acceptable (i.e., FNA or pleural fluid cytology)
  5. Measurable or non-measurable disease
  6. 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

Information from the National Library of Medicine

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


Locations
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China
Shanghai Chest Hospital
Shanghai, China, 200030
Sponsors and Collaborators
Baohui Han
Investigators
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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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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
Keywords provided by Baohui Han, Shanghai Chest Hospital:
Lung adenocarcinoma,EGFR mutation, chemotherapy, gefitinib
Additional relevant MeSH terms:
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Carboplatin
Pemetrexed
Gefitinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Protein Kinase Inhibitors