Phase 2 Completed N=65 Treatment

Phase II Trial to Correlate Radiographic Response Induced By Gefitinib With Mutations in the Protein-Tyrosine Kinase Domain of the EGF Receptor Gene

Lung Cancer · Non-Small Cell Lung Cancer · Bronchioloalveolar Cancer

Source: ClinicalTrials.gov NCT00588445 ↗

Enrolled (actual)

Serious AEs

10.8%

Results posted

Jan 2016

Primary outcomePrimary: The Radiographic Response to Gefitinib — 21 participants

Summary

The purpose of this research study is to: * see if gefitinib pills can shrink Stage 1 or 2 non-small cell lung cancers before surgery * see if your non-small cell lung cancer has a mutation in a certain part of the EGFR gene * see if patients whose tumor does shrink with gefitinib treatment are more likely to have a mutation in a certain part of the EGFR gene * see if the pattern of protein expression in the blood is related to the tumor's sensitivity or resistance to gefitinib treatment. * see if expression of certain genes in the tumor are related to the tumor's sensitivity or resistance to gefitinib treatment.

Outcome Measures

Outcome	Result	p-value
PRIMARY The Radiographic Response to Gefitinib	21	—
SECONDARY Microarray Analysis to Identify Gene(s) or Gene Clusters That Exhibit Changes in Gene Expression; Time to Relapse and Overall Survival Data	85; 76; 98; 92	—

Eligibility Criteria

Inclusion Criteria

Pathologic confirmation of malignancy at Memorial Sloan-Kettering
Patients must have previously untreated stage I or II NSCLC (T11-2N0M0, T1-2N1M0, T3N0M0) and 1 of the following features: never smoker or 18 years.
Measurable indicator lesions
Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

Pregnant or lactating women or women of childbearing potential not using effective contraception. Men participating in the trial must also use effective contraception when sexually active.
Patients may not be receiving any other investigational agents.
Any history of or evidence of interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00588445). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.