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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

Tracking Information
First Submitted Date  ICMJE December 11, 2017
First Posted Date  ICMJE December 15, 2017
Last Update Posted Date March 28, 2019
Actual Study Start Date  ICMJE December 1, 2016
Estimated Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2017)
disease progression-free survival [ Time Frame: 3 years ]
the last patient into group for three years or dead
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2017)
  • overall survival [ Time Frame: 5 years ]
    the last patients into group for 5 years or dead
  • side-effects [ Time Frame: 3 years ]
    the last patient into group for 3 years or dead
  • overall response rate [ Time Frame: 3 years ]
    the last patient into group for 3 years or dead
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pemetrexed/Cisplatin Intercalating Gefitinib Treating EGFR Wild NSCLC
Official Title  ICMJE The Phase Three Trials of Pemetrexed/Cisplatin Intercalating Gefitinib vs Pemetrexed/Cisplatin Treating EGFR Wild NSCLC(Non Squamous Cell Carcinoma)
Brief Summary To investigate the curative effect between Pemetrexed/Cisplatin and Pemetrexed/Cisplatin intercalating Gefitinib Treating EGFR Wild NSCLC
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non Small Cell Lung Cancer
Intervention  ICMJE
  • Drug: pemetrexed/cisplatin intercalating gefitinib
  • Drug: pemetrexed/cisplatin
Study Arms  ICMJE
  • 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

    Intervention: 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
    Intervention: Drug: pemetrexed/cisplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 11, 2017)
178
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2021
Estimated Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hailing Yang, MD 00862083062825 bjrf2009@yahoo.com
Contact: Fengnan Wang, MD 00862083062825 wangfengnan@hotmail.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03374280
Other Study ID Numbers  ICMJE GuangzhouMC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Haihong Yang, MD, Pricipal investigator, Guangzhou Medical University
Study Sponsor  ICMJE Guangzhou Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jiajia Yu, MD the ethics committee of the first affiliated hospital of Guangzhou MC
PRS Account Guangzhou Medical University
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP