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Intercalated Administration of PamCis With Gefitinib or Placebo as First Line Lung Adenocarcinoma in Never Smokers

NCT01502202 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2012-06-20

No results posted yet for this study

Summary

Intercalated administration of Iressa® (gefitinib) on days 5-18 of chemotherapy cycle improve the efficacy of Pemetrexed/platinum regimen given as first-line treatment for never-smokers with advanced (stage IIIB/IV) lung adenocarcinoma.

Conditions

  • Non Small Cell Lung Cancer
  • Adenocarcinoma

Interventions

DRUG

Gefitinib

Gefitinib 250mg, per PO. daily, D 5-18 (during 14 days)

DRUG

Placebo

Placebo 1 tablet, per PO, Daily on D 5-18 (during 14 days)

DRUG

Pemetrexed plusCIsplatin

Pemetrexed 500mg/m2 on D1 plus Cisplatin 75mg/m2 on D1 every 3 weeks maximum 9 cycles

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • National Cancer Center, Korea

    lead OTHER_GOV

Principal Investigators

  • Jin Soo Lee, M.D. PhD. · National Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2014-08-31
Completion
2015-02-28

Countries

  • South Korea

Study Locations

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Entities

Drugs
Companies

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 NCT01502202 on ClinicalTrials.gov