Clinical Research Details
Title:
OSI-774-302 A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Single-agent Erlotinib Following Complete Tumor Resection with or without Adjuvant Chemotherapy in Patients with Stage IB-IIIA Non-small Cell Lung Carcinoma who have EGFR-positive Tumors.
Purpose:
The primary objectives of this study are to assess the efficacy of single-agent, oral, once daily erlotinib at 150 mg/day following complete surgical resection and to assess for an increase in DFS in patients with EGFR-positive tumors.
Study Number:
109438
Number of Patients:
945
Elgibility:
Participants must have histologically confirmed diagnosis of stage IB-IIIA NSCLC of a single, solitary, discrete nodule or mass (or with Microscopic N2 disease that is not obvious by either PET or CT scans before surgery) that is completely resected (lobectomy, bilobectomy, sleeve lobectomy, or pneumonectomy). Participant must be randomized within 6 months of day of surgery if they received adjuvant chemo or within 3 months of surgery if they did not receive adjuvant chemo.
Treatment:
You will be assigned by lottery to receive either a 150 mg tablet of erlotinib or an identical looking placebo tablet (sugar pill) for up to 2 years. Whether you will receive erlotinib or the placebo tablet will be determined by a computer and neither you nor the researcher will choose the group into which you are placed. Neither you nor your doctor will know which tablet you are receiving but you will receive the same type of tablet for the remainder of the study.
Principal Investigator:
Enrollment Phone:
(708) 327-3229