search
Back to results

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
Fudan 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 PFS

Eligibility Criteria

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

Inclusion Criteria:

  1. Sign the informed consent
  2. ≥18 years
  3. According to RECIST 1.1 standard, at least one measurable lesions
  4. Histology and cytology confirmed with unfavorable surgical locally advanced stage (stage IIIB) or metastatic NSCLC (IV), Sensitive EGFR gene mutation
  5. 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
  6. PS=0,1,2
  7. No serious blood, heart, lung, liver and kidney dysfunction, and immune deficiency
  8. Hb≥9g/dL;WBC≥3*109/L,ANC≥1.5*109/L,PLT≥75*109/L
  9. Men or women of childbearing age in the experiment are willing to take contraceptive measures
  10. Estimated survival period for 3 months or more

Exclusion Criteria:

  1. The palliative chemotherapy ever use docetaxel and pemetrexed
  2. small cell lung cancer non small cell hybrid
  3. Women during pregnancy or lactation
  4. In the past the anti-tumor treatment of any outstanding ease of > CTCAE 2 levels of toxicity
  5. Ccr<30 ml/min (calculated by Cockcroft-Gault formula)
  6. 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)
  7. Severe symptomatic heart disease
  8. Symptomatic brain metastases
  9. In the last 5 years have been or are suffering from other histological types of malignant tumor
  10. There are serious or uncontrolled systemic diseases
  11. During the study period planned radiotherapy on target lesion
  12. During the study period, plans to use other antineoplastic therapy
  13. 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

First Posted
January 2, 2014
Last Updated
February 22, 2016
Sponsor
Fudan University
search

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

We'll reach out to this number within 24 hrs