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Chemotherapy Plus Gefitinib for Advanced Lung Adenocarcinoma and Sensitive EGFR Mutations: a Randomized Controlled Trial

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ClinicalTrials.gov Identifier: NCT02951637
Recruitment Status : Unknown
Verified October 2016 by Aiqin Gu, Shanghai Chest Hospital.
Recruitment status was:  Not yet recruiting
First Posted : November 1, 2016
Last Update Posted : November 1, 2016
Sponsor:
Collaborators:
Ruijin Hospital
Changhai Hospital
Information provided by (Responsible Party):
Aiqin Gu, Shanghai Chest Hospital

Study Description
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Brief Summary:
The purpose of this study is to compare chemotherapy and gefitinib in combination with gefitinib alone as first-line therapy for adenocarcinoma, in terms of efficacy and safety.

Condition or disease Intervention/treatment Phase
Lung Adenocarcinoma Drug: Pemetrexed plus carboplatin combined with gefitinib Drug: Gefitinib Phase 2

Detailed Description:

The primary endpoints is to compare the progression-free survival (PFS) of pemetrexed plus carboplatin combined with gefitinib to gefitinib alone as first-line therapy for lung adenocarcinoma.

In addition, the overall survival and safety index will be collected for analyses.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Chemotherapy Plus Gefitinib Versus Gefitinib Alone as First-line Treatment for Patients With Advanced Lung Adenocarcinoma and Sensitive EGFR Mutations: a Randomized Controlled Trial
Study Start Date : December 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : December 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Group A
Patient will be administrated with Pemetrexed plus carboplatin combined with gefitinib
 Drug: Pemetrexed plus carboplatin combined with gefitinib
Pemetrexed (500mg/m(2) d1) plus carboplatin (AUC5 d1) combined with gefitinib (250mg d4-28) and repeat every four weeks for up to six cycles and then continue to receive pemetrexed combined with gefitinib every four weeks.
Other Name: Combination of chemotherapy and EGFR TKI
Experimental: Group B
Patient will be administrated with gefitinib
 Drug: Gefitinib
Gefitinib (250mg daily)
Other Name: EGFR TKI


Outcome Measures
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Primary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: 16 months ]

Secondary Outcome Measures :
  1. overall survival (OS) [ Time Frame: 32 months ]
  2. Objective response rate (ORR) [ Time Frame: 6 months ]
  3. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients had to voluntarily join the study and give written informed consent for the study;
  2. Histologically documented, unresectable, inoperable, locally advanced, recurrent or metastatic stage IIIB or IV Non-Small Cell Lung Cancer (NSCLC);
  3. A cytologic diagnosis is acceptable (FNA or pleural fluid cytology)
  4. Sensitive EGFR mutations (19del, 21L858R);
  5. At least 1 unidimensionally measurable lesion meeting Response Evaluation Criteria in Solid Tumours (RECIST) criteria;
  6. Patients did not receive systemic anti-cancer therapy previously;
  7. Able to comply with study and follow-up procedures;
  8. Age >= 18 years, ECOG PS: 0-1, estimated survival duration more than 3 months;

Exclusion Criteria:

  1. Small cell lung cancer (including patients with mixed small cell lung cancer and non-small cell lung cancer);
  2. Evidence of small cell, carcinoid, or mixed small cell/non-small cell histology;
  3. EGFR wild-type patients, or patients with rare EGFR mutations or complex EGFR mutations;
  4. Previously (within 5 years) or presently suffering from other malignancies, except for cured cervical carcinoma in situ, non-melanoma skin cancers and superficial bladder cancer [Ta (noninvasive carcinoma), Tis (carcinoma in situ) and T1 (invasion into lamina propria)];
  5. Symptomatic or untreated brain metastases;
  6. 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);
  7. 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;
  8. Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation, or prior surgical procedures affecting absorption;
  9. Pregnancy or lactation.
Contacts and Locations
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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): NCT02951637


Contacts
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Contact: Aiqin Gu, MD 13916720655 Guaiqin11@126.com

Sponsors and Collaborators
Shanghai Chest Hospital
Ruijin Hospital
Changhai Hospital
Investigators
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Principal Investigator: Aiqin Gu, MD Shanghai Chest Hospital
More Information
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Responsible Party: Aiqin Gu, Principal Investigator, Shanghai Chest Hospital
ClinicalTrials.gov Identifier: NCT02951637    
Other Study ID Numbers: Chest004
First Posted: November 1, 2016    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Aiqin Gu, Shanghai Chest Hospital:
Adenocarcinoma, EGFR, Gefitinib, Pemetrexed, Carboplatin
Additional relevant MeSH terms:
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Adenocarcinoma
Adenocarcinoma of Lung
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Carboplatin
Pemetrexed
Gefitinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Protein Kinase Inhibitors