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Pemetrexed/Cisplatin Intercalating Gefitinib Treating EGFR Wild NSCLC

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ClinicalTrials.gov Identifier: NCT03374280
Recruitment Status : Recruiting
First Posted : December 15, 2017
Last Update Posted : March 28, 2019
Sponsor:
Information provided by (Responsible Party):
Haihong Yang, MD, Pricipal investigator, Guangzhou Medical University

Study Description
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Brief Summary:
To investigate the curative effect between Pemetrexed/Cisplatin and Pemetrexed/Cisplatin intercalating Gefitinib Treating EGFR Wild NSCLC

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Drug: pemetrexed/cisplatin intercalating gefitinib Drug: pemetrexed/cisplatin Phase 2

Detailed Description:
In preclinical data, it is identified that pemetrexed combined with erlotinib could achieve good response than pemetrexed because EGFR-TKI (erlotinib) could enhance the sensitivity of pemetrexed. So we design the trial to investigate curative effect between Pemetrexed/Cisplatin and Pemetrexed/Cisplatin intercalating Gefitinib Treating EGFR Wild NSCLC.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 178 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Phase Three Trials of Pemetrexed/Cisplatin Intercalating Gefitinib vs Pemetrexed/Cisplatin Treating EGFR Wild NSCLC(Non Squamous Cell Carcinoma)
Actual Study Start Date : December 1, 2016
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: pemetrexed/cisplatin intercalating gefitinib

pemetrexed 500mg/m2 d1; cisplatin 30mg/m2 d1-2 ;gefitinib 250mg d3-20d, to 4 cycles.

pemetrexed 500mg/m2 d1; gefitinib 250mg d2-20d to disease progression or untolerable

 Drug: pemetrexed/cisplatin intercalating gefitinib
Active Comparator: pemetrexed/cisplatin
pemetrexed 500mg/m2 d1; cisplatin 30mg/m2 d1-2 to 4 cycles. pemetrexed 500mg/m2 d1 to disease progression or untolerable
 Drug: pemetrexed/cisplatin


Outcome Measures
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Primary Outcome Measures :
  1. disease progression-free survival [ Time Frame: 3 years ]
    the last patient into group for three years or dead


Secondary Outcome Measures :
  1. overall survival [ Time Frame: 5 years ]
    the last patients into group for 5 years or dead

  2. side-effects [ Time Frame: 3 years ]
    the last patient into group for 3 years or dead

  3. overall response rate [ Time Frame: 3 years ]
    the last patient into group for 3 years or dead


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1.Histological or cytological diagnosis of small-cll lung cancer histology

2.18 years or older

3.Eastern Cooperative Oncology Group (ECOG) Performance Status no more than 2

4.Local stage SCLC without distant metastases

5.After 1st-line chemotherapy (EP or IP) at least 4 cycles

6.After radical radiotherapy for primary tumor and lymph node drainage area:including concurrent or sequence chemoradiotherapy

7.CR or PR assessment by RECIST(1.0) before randomized

8.Haemoglobin 10.0 g/dl, Absolute neutrophil count (ANC) 1.5^9/L, platelets 100 x 10^9/L

9.Total bilirubin 1.5 x upper limit of normal (ULN) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases

10.Creatinine clearance 60ml/min (calculated according to Cockcroft-gault formula)

Exclusion Criteria:

  1. Mixed non-small cell lung cancer histology
  2. Neck and supraclavicular lymph node metastasis
  3. Be allergic to temozolomide or intolerable to radiotherapy
  4. Any unstable systemic disease
  5. Pregnant or lactating women
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): NCT03374280


Contacts
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Contact: Hailing Yang, MD 00862083062825 bjrf2009@yahoo.com
Contact: Fengnan Wang, MD 00862083062825 wangfengnan@hotmail.com

Locations
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China, Guangdong
The first affiliated hospital of Guangzhou MC Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Haihong Yang, MD    0862083062825    bjrf2009@yahoo.com   
Principal Investigator: Haihong Yang, Dr.         
Sponsors and Collaborators
Guangzhou Medical University
Investigators
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Study Director: Jiajia Yu, MD the ethics committee of the first affiliated hospital of Guangzhou MC
More Information
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Responsible Party: Haihong Yang, MD, Pricipal investigator, Chief Physician, Guangzhou Medical University
ClinicalTrials.gov Identifier: NCT03374280    
Other Study ID Numbers: GuangzhouMC
First Posted: December 15, 2017    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Haihong Yang, MD, Pricipal investigator, Guangzhou Medical University:
non small cell lung cancer
Gefitinib
EGFR negative
Pemetrexed
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
 Cisplatin
Pemetrexed
Gefitinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Protein Kinase Inhibitors