Safety and Effectiveness Study of Chemotherapy in Combination With Erlotinib,or Sequential Erlotinib for Treatment in Patients With NSCLC
Primary Purpose
Non Small Cell Lung Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
docetaxel
pemetrexed
Erlotinib
Sponsored by

About this trial
This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring PFS
Eligibility Criteria
Inclusion Criteria:
- Sign the informed consent
- ≥18 years
- According to RECIST 1.1 standard, at least one measurable lesions
- Histology and cytology confirmed with unfavorable surgical locally advanced stage (stage IIIB) or metastatic NSCLC (IV), Sensitive EGFR gene mutation
- Palliative treatment has received two medicine first-line platinum-based chemotherapy and EGFR - TKI second-line treatment and objective clinical benefit (CR, PR or SD is more than 6 months), RESIST standard curative effect evaluation for progress
- PS=0,1,2
- No serious blood, heart, lung, liver and kidney dysfunction, and immune deficiency
- Hb≥9g/dL;WBC≥3*109/L,ANC≥1.5*109/L,PLT≥75*109/L
- Men or women of childbearing age in the experiment are willing to take contraceptive measures
- Estimated survival period for 3 months or more
Exclusion Criteria:
- The palliative chemotherapy ever use docetaxel and pemetrexed
- small cell lung cancer non small cell hybrid
- Women during pregnancy or lactation
- In the past the anti-tumor treatment of any outstanding ease of > CTCAE 2 levels of toxicity
- Ccr<30 ml/min (calculated by Cockcroft-Gault formula)
- hepatic insufficiency: Tbil> 1.5×ULN ALT and AST > 2.5×ULN (Patients with liver metastasis>5×ULN) Alkaline phosphatase>2.5 ×ULN(Patients with liver metastasis>5×ULN)
- Severe symptomatic heart disease
- Symptomatic brain metastases
- In the last 5 years have been or are suffering from other histological types of malignant tumor
- There are serious or uncontrolled systemic diseases
- During the study period planned radiotherapy on target lesion
- During the study period, plans to use other antineoplastic therapy
- Clinical study on treatment of 30 days beginning period prior to participate in any study drug
Sites / Locations
- Cancer hospital Fudan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
combination with Erlotinib
sequential chemotherapy for Erlotinib
Arm Description
Erlotinib 150mg qd combination with docetaxel 75mg/m2 or pemetrexed 500mg/m2
docetaxel 75mg/m2 or pemetrexed 500mg/m2,after PD,Erlotinib 150mg qd
Outcomes
Primary Outcome Measures
Progression-free survival (PFS)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02037997
Brief Title
Safety and Effectiveness Study of Chemotherapy in Combination With Erlotinib,or Sequential Erlotinib for Treatment in Patients With NSCLC
Official Title
Chemotherapy in Combination With Erlotinib, or Sequential Chemotherapy for Erlotinib for Treatment, EGFR - TKI Resistance of EGFR Mutations in Patients With NSCLC Randomized Controlled Phase II Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate and compare safety and effectiveness of Chemotherapy in Combination With Erlotinib,or Sequential Erlotinib for Treatment in Patients With EGFR - TKI Resistance of EGFR Mutations
Detailed Description
from the first cycle of treatment (day one) to two month after the last cycle
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
PFS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
combination with Erlotinib
Arm Type
Experimental
Arm Description
Erlotinib 150mg qd combination with docetaxel 75mg/m2 or pemetrexed 500mg/m2
Arm Title
sequential chemotherapy for Erlotinib
Arm Type
Active Comparator
Arm Description
docetaxel 75mg/m2 or pemetrexed 500mg/m2,after PD,Erlotinib 150mg qd
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Description
docetaxel 75mg/m2 ivgtt D1
Intervention Type
Drug
Intervention Name(s)
pemetrexed
Intervention Description
pemetrexed 500mg/m2 ivgtt D1
Intervention Type
Drug
Intervention Name(s)
Erlotinib
Intervention Description
Erlotinib 150mg qd
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Time Frame
from the first cycle of treatment (day one) to two month after the last cycle
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Sign the informed consent
≥18 years
According to RECIST 1.1 standard, at least one measurable lesions
Histology and cytology confirmed with unfavorable surgical locally advanced stage (stage IIIB) or metastatic NSCLC (IV), Sensitive EGFR gene mutation
Palliative treatment has received two medicine first-line platinum-based chemotherapy and EGFR - TKI second-line treatment and objective clinical benefit (CR, PR or SD is more than 6 months), RESIST standard curative effect evaluation for progress
PS=0,1,2
No serious blood, heart, lung, liver and kidney dysfunction, and immune deficiency
Hb≥9g/dL;WBC≥3*109/L,ANC≥1.5*109/L,PLT≥75*109/L
Men or women of childbearing age in the experiment are willing to take contraceptive measures
Estimated survival period for 3 months or more
Exclusion Criteria:
The palliative chemotherapy ever use docetaxel and pemetrexed
small cell lung cancer non small cell hybrid
Women during pregnancy or lactation
In the past the anti-tumor treatment of any outstanding ease of > CTCAE 2 levels of toxicity
Ccr<30 ml/min (calculated by Cockcroft-Gault formula)
hepatic insufficiency: Tbil> 1.5×ULN ALT and AST > 2.5×ULN (Patients with liver metastasis>5×ULN) Alkaline phosphatase>2.5 ×ULN(Patients with liver metastasis>5×ULN)
Severe symptomatic heart disease
Symptomatic brain metastases
In the last 5 years have been or are suffering from other histological types of malignant tumor
There are serious or uncontrolled systemic diseases
During the study period planned radiotherapy on target lesion
During the study period, plans to use other antineoplastic therapy
Clinical study on treatment of 30 days beginning period prior to participate in any study drug
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chang J hua, PD
Phone
13916619284
Email
changjianhua@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chang J hua, PD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer hospital Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chang J hua, PD
Phone
13916619284
Email
changjianhua@163.com
12. IPD Sharing Statement
Learn more about this trial
Safety and Effectiveness Study of Chemotherapy in Combination With Erlotinib,or Sequential Erlotinib for Treatment in Patients With NSCLC
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