Erlotinib in Patients With Resected, Early Stage NSCLC With Confirmed Mutations in the EGFR
In this research study erlotinib will be given to eligible participants whose lung cancer has been removed by surgery. Eligible patients have adenocarcinoma, a type of non-small lung cancer, and must have 1 or more of the following characteristics: be female, be of Asian or Pacific Rim descent and/or be a never smoker. The potential participant's tumor will be examined for Epidermal growth factor (EGFR) mutations. EGFR is a protein that is overexpressed in most non-small cell lung cancers. Some EGFR has been found to have specific mutations and the participant must have one of these mutations in his tumor. Erlotinib blocks this protein and may control tumor growth and increase survival. Previous research has shown that erlotinib is most effective for people who have these specific mutations in the EGFR.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Dec 11, 2018 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Massachusetts General Hospital
- Interventions being studied
- Drug: Erlotinib
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Pathologically confirmed diagnosis of NSCLC of adenocarcinoma histology
- Stage IA-B, IIA-B, or IIIA by the American Joint Committee on Cancer 7th edition staging criteria
- Patients must have undergone surgical resection with curative intent within 6 months of enrollment
- Sufficient tumor tissue available for EGFR mutation analysis
- At least ONE of the following patient characteristics: previously detected deletion 19 or L858R EGFR mutation, female sex, history of never smoking, or Asian/Pacific Rim ethnicity (to be enrolled in the screening portion of trial).
- 18 years of age or older
- Tumor samples must have either exon 19 deletion mutations or the exon 21 L858R point mutation
- ECOG Performance status of 0,1, or 2
- Adequate organ function as outlined in protocol
- Radiographic evidence of recurrent NSCLC prior to erlotinib treatment
- Confirmed T790M resistance mutation in the primary tumor sample
- Prior exposure to EGFR tyrosine kinase inhibitors
- Known hypersensitivity to erlotinib, gefitinib, or any closely related drug
- Pregnant or breastfeeding women
- Any evidence of clinically active interstitial lung disease
- Current use of enzyme-inducing anti-epileptic drugs, including carbamazepine, oxcarbazepine, phenytoin, fosphenytoin, phenobarbital, and primidone
- Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
- Use of any non-FDA approved or investigational agent within 2 weeks of enrolling onto the trial, or failure to recover from the side effects of any of these agents
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Stanford UniversityStanford, California
- Massachusetts General HosptialBoston, Massachusetts
- Beth Israel Deaconess Medical CenterBoston, Massachusetts
- Dana-Farber Cancer InstituteBoston, Massachusetts
- North Shore Medical CenterPeabody, Massachusetts
- Washington University School of MedicineSt Louis, Missouri
- Memorial Sloan Kettering Cancer CenterNew York, New York
- Taussig Cancer CenterCleveland, Ohio
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 11, 2018. Always confirm current availability with the study team.