Maintenance ZD1839 (IRESSA®) Following Completion of Front Line, Platinum-Based, Double Chemotherapy in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (IMAC/Herbst)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00090675
Recruitment Status : Withdrawn (No patients randomised)
First Posted : September 3, 2004
Last Update Posted : January 29, 2013
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Brief Summary:
In this Phase IIIb, randomized, double-blind, maintenance study, 300 subjects with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) (Stage IIIB {T4-pleural effusion} and IV) who have SD or objective tumor response immediately following the completion of 4-6 cycles of front line, platinum-based, doublet chemotherapy will be randomized in a double-blind manner to receive either ZD1839 or placebo.

Condition or disease Intervention/treatment Phase
Non-Small-Cell Lung Carcinoma Drug: ZD1839 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase IIIb Randomized, Double-Blind Study Comparing Maintenance ZD1839 (IRESSA®) or Placebo Following Completion of Front Line, Platinum-Based, Double Chemotherapy in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer
Study Start Date : January 2006
Estimated Primary Completion Date : November 2007
Estimated Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Gefitinib
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Must sign Informed Consent
  • Females and males aged 18 years and over.
  • Confirmed stage IIIB (T4-pleural effusion) and IV NSCLC.
  • Either complete response, partial response, or stable disease following at least 4 cycles (3 in the setting of intolerable toxicity) but no more than 6 cycles of definitive front line, platinum-based, doublet chemotherapy.
  • No prior EGFR therapy
  • No newly diagnosed intracerebral metastases while receiving or after completing chemotherapy
  • At least 3 weeks (21 days) but no more than 4 weeks (28 days) since last dose of chemotherapy
  • Must be completely healed from previous major oncologic surgery
  • Life expectancy of ≥ 8 weeks.

Exclusion Criteria:

  • Known severe hypersensitivity to ZD1839 or any of the excipients of these products.
  • Any evidence of clinically active interstitial lung disease (subjects with chronic, stable, radiographic changes who are asymptomatic need not be excluded).
  • Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ.
  • Any unresolved chronic toxicity greater than common toxicity criteria (CTC) grade 2 from previous anticancer therapy excluding peripheral neuropathy or alopecia.
  • Evidence of any significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study.
  • Pregnancy or breast feeding (women of child bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy.
  • Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.
  • Signs of neurological symptoms consistent with new onset spinal cord compression or CNS metastases.
  • Treatment with any systemic anticancer therapies other than the prescribed protocol chemotherapy regimen (refer to Inclusion criterion -). Exception: Palliative radiotherapy for symptom relief of lesions present at diagnosis will be allowed; however, this radiotherapy must occur prior to completion of pre-study doublet chemotherapy.
  • Males must also be willing to practice acceptable methods of birth control while taking the drug to prevent pregnancy of a partner.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00090675

Sponsors and Collaborators
Study Director: Iressa Medical Science Director AstraZeneca Identifier: NCT00090675     History of Changes
Other Study ID Numbers: D7913L00019
Herbst trial
First Posted: September 3, 2004    Key Record Dates
Last Update Posted: January 29, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action