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Erlotinib Intercalated With Chemotherapy Versus Erlotinib as First Line Treatment in Stage IIIB/IV NSCLC Patients With EGFR Mutation

NCT02001896 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2013-12-05

No results posted yet for this study

Summary

This 2 arm study will compare the efficacy and safety of treatment with erlotinib intercalated with platinum-based therapy or erlotinib along, as first line treatment in Stage IIIB/IV Non-Small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor (EGFR) Mutation. Patients will be randomized to receive gemcitabine (1000mg/m2 iv) on days 1 , and cisplatin (75mg/m2) or carboplatin (5xAUC)on day 1, followed by erlotinib 150mg/day from day 15 to day 28 of each 4 week cycle for a total of 6 cycles,then followed by erlotinib monotherapy, or erlotinib 150mg/day .The anticipated time on study treatment is until disease progression, and the target sample size is 60 individuals.

Conditions

Interventions

DRUG

gemcitabine; cisplatin or carboplatin; erlotinib

DRUG

erlotinib

Sponsors & Collaborators

  • Xinjiang Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02001896 on ClinicalTrials.gov