Phase II Trial to Correlate Radiographic Response Induced By Gefitinib With Mutations in the Protein-Tyrosine Kinase Domain of the EGF Receptor Gene
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.
Checked against the public recordLast updated Jan 22, 2016 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Interventions being studied
- Drug: Gefitinib
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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 \< 15 pack year smoking history and/or bronchioloalveolar cancer (either pure BAC, BAC with focal invasion or adenocarcinoma with BAC features) * Patients must have been determined to be operable and resectable by the treating thoracic surgeon. * Age \>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).
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Memorial Sloan-Kettering Cancer CenterNew York, New York
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 22, 2016. Always confirm current availability with the study team.