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A Study of IRESSA Treatment Beyond Progression in Addition to Chemotherapy Versus Chemotherapy Alone

NCT01544179 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 265

Last updated 2020-09-25

Study results available
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Summary

The purpose of this study is to assess the efficacy and safety of gefitinib in patients who have progressed on first line gefitinib, comparing continuing gefitinib in addition to cisplatin plus pemetrexed combination chemotherapy versus cisplatin plus pemetrexed combination chemotherapy alone.

Conditions

Interventions

DRUG

Gefitinib

Investigational Drug

DRUG

Placebo

Matching placebo as comparator

DRUG

Pemetrexed

Chemotherapy (concomitant therapy)

DRUG

Cisplatin

Chemotherapy (concomitant therapy)

Sponsors & Collaborators

Principal Investigators

  • Yuri Rukazenkov, MD PhD, GCL Oncology · AstraZeneca Global R&D, Alderley park, Cheshire, SK10 4TG, UK

  • Tony Mok, M.D. · Department of Clinical Oncology, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, N.T., Hong KongDepartment of Clinical Oncology, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, N.T., Hong Kong

  • Jean-Charles Soria, MD, PHD · Institute Gustave Roussy, France

  • Haiyi Jiang, M.D. MSc · Zhangjiang Hi-tech Park, 3F, Room 3102, 199 Liangjing Road, Pudong Shanghai, postal code:201203

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-15
Primary Completion
2014-05-05
Completion
2019-11-20

Countries

  • China
  • France
  • Germany
  • Hong Kong
  • Hungary
  • Italy
  • Japan
  • Russia
  • South Korea
  • Spain
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT01544179 on ClinicalTrials.gov