CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 503 enrolled
Drug / intervention
gefitinib +2 moredrug
Likely dose
Gefitinib (IRESSA) given orally; specific dose not stated in documentAI-extracted
Key inclusion· 7
  • ✓Histologically confirmed primary non-small cell lung cancer (NSCLC), including bronchoalveolar carcinomas presenting as discrete solitary radiological mass or nodule
  • ✓Pathologically staged as IB, II, or IIIA NSCLC after complete resection
  • ✓Complete mediastinal lymph node resection or adequate sampling attempted at time of surgery
  • ✓Surgical resection must include lobectomy, sleeve resection, bilobectomy, or pneumonectomy with negative margins; segmentectomy or wedge resection patients ineligible
Key exclusion· 8
  • ✕Prior or concurrent malignancies (exception: disease-free ≥5 years or adequately treated non-melanomatous skin cancer or cervical carcinoma in situ)
  • ✕Mixed small cell and non-small cell carcinomas or pulmonary carcinoid tumors
  • ✕More than one discrete area of apparent primary cancer (even if within same lobe, T4, IIIB)
  • ✕Clinically significant or untreated ophthalmologic (e.g., Sjögren's) or gastrointestinal conditions (e.g., Crohn's disease, ulcerative colitis)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00049543
NCT00049543Phase 3Completed
CompareCT.gov

A Phase III Prospective Randomized, Double-Blind, Placebo-Controlled Trial of the Epidermal Growth Factor Receptor Antagonist, ZD1839 (IRESSA) in Completely Resected Primary Stage IB, II and IIIA Non-Small Cell Lung Cancer

National Cancer Institute (NCI)·interventional·Posted Jan 27, 2003·Updated Jan 1, 2015

In Brief

A Phase 3 clinical trial evaluating gefitinib, placebo, and 1 other intervention for Adenocarcinoma of the Lung and 8 related conditions. Completed, enrolled 503 participants across 1 site.

Detailed Summary

This randomized phase III trial studies how well gefitinib works in treating patients with stage IB, II, or IIIA non-small cell lung cancer that was completely removed by surgery. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known if gefitinib may be an effective treatment in preventing tumors from returning after they have been removed by surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdenocarcinoma of the Lung, Adenosquamous Cell Lung Cancer, Bronchoalveolar Cell Lung Cancer, Large Cell Lung Cancer, Squamous Cell Lung Cancer, Stage IB Non-small Cell Lung Cancer, Stage IIA Non-small Cell Lung Cancer, Stage IIB Non-small Cell Lung Cancer, Stage IIIA Non-small Cell Lung Cancer
CountriesCanada
Collaborators--

Timeline

Phase 3CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartSep 1, 2002
Primary CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 8.6 yearsPosted 23.4 years ago

Interventions

gefitinibdrug

Given PO

placeboother

Given PO

laboratory biomarker analysisother

Correlative studies