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A Chinese Randomized Crossover Study of Erlotinib Versus Docetaxel/Cisplatin in Previously Untreated Stage IIIB/IV Lung Adenocarcinoma With EGFR Mutations

NCT01131429 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2010-05-27

No results posted yet for this study

Summary

Objective: the objective of this study in china is to clarify, whether the overall survival is different between previously untreated stage IIIB/IV lung adenocarcinoma with EGFR mutations receiving first-line erlotinib plus second-line docetaxel/cisplatin and those receiving first-line docetaxel/cisplatin plus second-line erlotinib .

Conditions

  • Neoplasms, Lung
  • Carcinoma, Non-Small Cell Lung
  • Drug Therapy
  • Genes, EGFR

Interventions

DRUG

Erlotinib

Erlotinib 150 mg/d per os until proven disease progression

DRUG

Docetaxel

Docetaxel 75mg/m2 iv day 1 every 3 weeks as second-line treatment

DRUG

Cisplatin

cisplatin 75mg/ m2 iv day 1 every 3 weeks as second-line treatment

DRUG

Docetaxel

Docetaxel 75mg/m2 iv day 1 every 3 weeks for 6 cycles at most

DRUG

Cisplatin

Cisplatin 75mg/m2 iv day 1 every 3 weeks for 6 cycles at most

DRUG

Erlotinib

Erlotinib 150 mg/d per os as second-line treatment

Sponsors & Collaborators

  • Chinese PLA General Hospital

    lead OTHER

Principal Investigators

  • Liang-An Chen, M.D., Ph.D. · Chinese PLA General Hospital, Beijing, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2013-06-30
Completion
2015-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT01131429 on ClinicalTrials.gov