Alliance A081105: Randomized Double Blind Placebo Controlled Study of Erlotinib or Placebo in Patients with Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer (NSCLC).

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Alliance A081105: Randomized Double Blind Placebo Controlled Study of Erlotinib or Placebo in Patients with Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer (NSCLC).

OBJECTIVES
2.1 Primary Objective
To assess whether adjuvant therapy with erlotinib will result in improved overall survival (OS) over placebo for patients with completely resected stage IB (?4 cm)-IIIA EGFR mutant NSCLC (confirmed centrally) following complete resection and standard post-operative therapy.
2.2 Secondary Objectives
2.2.1 To assess whether adjuvant therapy with erlotinib will result in improved disease free survival (DFS) over placebo for patients with completely resected stage IB (?4 cm)-IIIA EGFR mutant NSCLC (confirmed centrally) following complete resection and standard post-operative therapy, both overall and within the stage subgroups: IB and II/IIIA.
2.2.2 To evaluate the safety profile of erlotinib in the adjuvant setting.
2.2.3 To assess whether adjuvant therapy with erlotinib will result in improved DFS rate at 2 years, and OS rate at 5 years over placebo for patients with completely resected stage IB (? 4cm)-IIIA EGFR mutant NSCLC (confirmed centrally) following complete resection and standard post-operative therapy, both overall and within the stage subgroups: IB and II/IIIA.
2.2.4 To assess the primary and secondary objectives in all randomized patients, regardless of central confirmation of the EGFR mutant status.

Protocol Number: 031503
Phase: Phase III
Applicable Disease Sites: Lung
Drugs Involved: ERLOTINIB/PLACEBO
Principal Investigator: Joseph Aisner
Research Nurse: Michelle Orlick
Scope: National
Therapies Involved: Chemotherapy single agent systemic
Participating Institutions: Rutgers Cancer Institute of New Jersey
Robert Wood Johnson University Hospital Somerset

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@cinj.rutgers.edu.

 

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