Safety and Effectiveness Study of Chemotherapy in Combination With Erlotinib,or Sequential Erlotinib for Treatment in Patients With NSCLC

February 22, 2016 updated by: Chang Jian Hua, Fudan University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

from the first cycle of treatment (day one) to two month after the last cycle

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Cancer hospital Fudan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: combination with Erlotinib
Erlotinib 150mg qd combination with docetaxel 75mg/m2 or pemetrexed 500mg/m2
Drug: docetaxel
docetaxel 75mg/m2 ivgtt D1
Drug: pemetrexed
pemetrexed 500mg/m2 ivgtt D1
Drug: Erlotinib
Erlotinib 150mg qd
Active Comparator: sequential chemotherapy for Erlotinib
docetaxel 75mg/m2 or pemetrexed 500mg/m2，after PD，Erlotinib 150mg qd
Drug: docetaxel
docetaxel 75mg/m2 ivgtt D1
Drug: pemetrexed
pemetrexed 500mg/m2 ivgtt D1
Drug: Erlotinib
Erlotinib 150mg qd

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival (PFS)
Time Frame: from the first cycle of treatment (day one) to two month after the last cycle
from the first cycle of treatment (day one) to two month after the last cycle

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Principal Investigator: Chang J hua, PD, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

January 2, 2014

First Submitted That Met QC Criteria

January 15, 2014

First Posted (Estimate)

January 16, 2014

Study Record Updates

Last Update Posted (Estimate)

February 23, 2016

Last Update Submitted That Met QC Criteria

February 22, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CJH-Erlotinib-2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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