Gefitinib in Treating Patients With Stage IB, II, or IIIA Non-small Cell Lung Cancer That Was Completely Removed by Surgery

NCT00049543 | Completed Phase 3 Results DMC

• 7 other identifiers: NCI-2014-00650SWOG-CAN-NCIC-BR19ECOG-CAN-NCIC-BR19BR19CDR0000258118CAN-NCIC-BR19BR.19
• Study Type: interventional
• Target: 503
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adenocarcinoma 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

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  The survival experience of patients in both treatment groups will be described by the Kaplan-Meier method. A stratified log-rank test will be used as the primary method to compare the overall survival between two arms adjusting for the stratification factors. An unadjusted analysis will also be performed. Five years survival rate will be reported.

  From randomization to the time of death from any cause, assessed up to 5 years

Secondary Outcomes (2)

• Disease Free Survival

  From randomization to the time of documented recurrence of the primary cancer, assessed up to 5 years

• Incidence of Toxicities Graded Using the NCI Common Terminology Criteria for Adverse Events Version 3.0

  Up to 5 years

Study Arms (2)

Arm I (gefitinib)

EXPERIMENTAL

Patients receive gefitinib PO QD for 2 years in the absence of disease progression or unacceptable toxicity.

Drug: gefitinib; Other: laboratory biomarker analysis

Arm II (placebo)

PLACEBO COMPARATOR

Patients receive placebo PO QD for 2 years in the absence of disease progression or unacceptable toxicity.

Other: placebo; Other: laboratory biomarker analysis

Interventions

gefitinib DRUG

Given PO

Also known as: Iressa, ZD 1839

Arm I (gefitinib)

placebo OTHER

Given PO

Also known as: PLCB

Arm II (placebo)

laboratory biomarker analysis OTHER

Correlative studies

Arm I (gefitinib); Arm II (placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histological proof of a primary non-small cell lung cancer (bronchoalveolar carcinomas presenting as a discrete solitary radiological mass or nodule are eligible)
• Patients must be classified post-operatively as stage IB, II or IIIA on the basis of pathologic criteria
• At the time of resection a complete mediastinal lymph node resection or at least lymph node sampling should have been attempted; if a complete mediastinal lymph node resection or lymph node sampling was not undertaken, any mediastinal lymph node which measured 1.5 cm or more on the pre-surgical computed tomography (CT)/magnetic resonance imaging (MRI) scan or any area of increased uptake in the mediastinum on a pre-surgical positron emission tomography (PET) scan must have been biopsied; note: a pre-surgical PET scan is not mandatory
• The nodal tissue must be labelled according to the recommendations of the American Thoracic Society; surgeons are encouraged to dissect or sample all accessible nodal levels; the desirable levels for biopsy are:
• Right upper lobe: 4, 7, 10
• Right middle lobe: 4, 7, 10
• Right lower lobe: 4, 7, 9, 10
• Left upper lobe: 5, 6, 7, 10
• Left lower lobe: 7, 9, 10
• Surgery may consist of lobectomy, sleeve resection, bilobectomy or pneumonectomy as determined by the attending surgeon based on the intraoperative findings; patients who have had only segmentectomies or wedge resections are not eligible for this study; all gross disease must have been removed at the end of surgery; all surgical margins of resection must be negative for tumor
• No more than 16 weeks may have elapsed between surgery and randomization; for patients who received post-operative adjuvant platinum-based chemotherapy, no more than 26 weeks may have elapsed between surgery and randomization
• Patient must consent to provision of and investigator(s) must agree to submit a representative formalin fixed paraffin block of tumor tissue at the request of the Central Tumor Bank in order that the specific EGFR correlative marker assays may be conducted
• The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
• Leukocytes \>= 3.0 x 10\^9/L or \>= 3000/ul
• Absolute granulocyte count \>= 1.5 x 10\^9/L or \>= 1,500/ul

You may not qualify if:

• Prior or concurrent malignancies; patients who have had a previous diagnosis of cancer, if they remain free of recurrence and metastases five years or more following the end of treatment and, in the opinion of the treating physician do not have a substantial risk of recurrence of the prior malignancy, are eligible for the study; patients who have been adequately treated for non-melanomatous skin cancer or carcinoma in situ of the cervix are eligible irrespective of when that treatment was given
• A combination of small cell and non-small cell carcinomas or a pulmonary carcinoid tumor
• More than one discrete area of apparent primary cancer (even if within the same lobe, T4, IIIB)
• Clinically significant or untreated ophthalmologic (e.g. Sjogren's etc.) or gastrointestinal conditions (e.g. Crohn's disease, ulcerative colitis)
• Any active pathological condition that would render the protocol treatment dangerous such as: uncontrolled congestive heart failure, angina, or arrhythmias, active uncontrolled infection, or others
• A history of psychiatric or neurological disorder that would make the obtainment of informed consent problematic or that would limit compliance with study requirements
• Patient, if female, is pregnant or breast-feeding
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to the agents used on this trial; patients with ongoing use of phenytoin, carbamazepine, barbiturates, rifampicin, or St John's Wort are excluded
• Incomplete healing from previous oncologic or other major surgery

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Cancer Institute of Canada Clinical Trials Group

Kingston, Ontario, K7L 3N6, Canada

Location

MeSH Terms

Conditions

Adenocarcinoma of Lung; Adenocarcinoma, Bronchiolo-Alveolar; Carcinoma, Non-Small-Cell Lung

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Keyue Ding
• Organization: NCIC Clinical Trials Group

king@ctg.queensu.ca

1-613-533-6000

Study Officials

• Glennwood Goss

  Canadian Cancer Trials Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2002
• First Posted: January 27, 2003
• Study Start: September 1, 2002
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: January 1, 2015
• Results First Posted: January 1, 2015

Record last verified: 2014-03

Locations

CA (1)