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

Fudan University1 site in 1 country80 target enrollmentDecember 2013

ConditionsNon Small Cell Lung Cancer

Interventionsdocetaxel pemetrexed Erlotinib

Drugsdocetaxel pemetrexed Erlotinib

Overview

Phase: Phase 2
Intervention: docetaxel
Conditions: Non Small Cell Lung Cancer
Sponsor: Fudan University
Enrollment: 80
Locations: 1
Primary Endpoint: Progression-free survival (PFS)
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

December 2013

End Date

December 2017

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Fudan University

Responsible Party

Principal Investigator

Chang Jian Hua

attending

Fudan University

Eligibility Criteria

Inclusion Criteria

•Sign the informed consent
•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
•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