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Pemetrexed/Cisplatin Intercalating Gefitinib Treating EGFR Wild NSCLC

Primary Purpose

Non Small Cell Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
pemetrexed/cisplatin intercalating gefitinib
pemetrexed/cisplatin
Sponsored by
Guangzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring non small cell lung cancer, Gefitinib, EGFR negative, Pemetrexed

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The first affiliated hospital of Guangzhou MCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

pemetrexed/cisplatin intercalating gefitinib

pemetrexed/cisplatin

Arm Description

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

pemetrexed 500mg/m2 d1; cisplatin 30mg/m2 d1-2 to 4 cycles. pemetrexed 500mg/m2 d1 to disease progression or untolerable

Outcomes

Primary Outcome Measures

disease progression-free survival
the last patient into group for three years or dead

Secondary Outcome Measures

overall survival
the last patients into group for 5 years or dead
side-effects
the last patient into group for 3 years or dead
overall response rate
the last patient into group for 3 years or dead

Full Information

First Posted
December 11, 2017
Last Updated
March 27, 2019
Sponsor
Guangzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03374280
Brief Title
Pemetrexed/Cisplatin Intercalating Gefitinib Treating EGFR Wild NSCLC
Official Title
The Phase Three Trials of Pemetrexed/Cisplatin Intercalating Gefitinib vs Pemetrexed/Cisplatin Treating EGFR Wild NSCLC(Non Squamous Cell Carcinoma)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
December 30, 2019 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
Keywords
non small cell lung cancer, Gefitinib, EGFR negative, Pemetrexed

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
178 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
pemetrexed/cisplatin intercalating gefitinib
Arm Type
Experimental
Arm Description
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
Arm Title
pemetrexed/cisplatin
Arm Type
Active Comparator
Arm Description
pemetrexed 500mg/m2 d1; cisplatin 30mg/m2 d1-2 to 4 cycles. pemetrexed 500mg/m2 d1 to disease progression or untolerable
Intervention Type
Drug
Intervention Name(s)
pemetrexed/cisplatin intercalating gefitinib
Intervention Type
Drug
Intervention Name(s)
pemetrexed/cisplatin
Primary Outcome Measure Information:
Title
disease progression-free survival
Description
the last patient into group for three years or dead
Time Frame
3 years
Secondary Outcome Measure Information:
Title
overall survival
Description
the last patients into group for 5 years or dead
Time Frame
5 years
Title
side-effects
Description
the last patient into group for 3 years or dead
Time Frame
3 years
Title
overall response rate
Description
the last patient into group for 3 years or dead
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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: Mixed non-small cell lung cancer histology Neck and supraclavicular lymph node metastasis Be allergic to temozolomide or intolerable to radiotherapy Any unstable systemic disease Pregnant or lactating women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hailing Yang, MD
Phone
00862083062825
Email
bjrf2009@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Fengnan Wang, MD
Phone
00862083062825
Email
wangfengnan@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiajia Yu, MD
Organizational Affiliation
the ethics committee of the first affiliated hospital of Guangzhou MC
Official's Role
Study Director
Facility Information:
Facility Name
The first affiliated hospital of Guangzhou MC
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haihong Yang, MD
Phone
0862083062825
Email
bjrf2009@yahoo.com
First Name & Middle Initial & Last Name & Degree
Haihong Yang, Dr.

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Pemetrexed/Cisplatin Intercalating Gefitinib Treating EGFR Wild NSCLC

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