A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Single-agent Tarceva® (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
A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Single-agent Tarceva® (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
This is a study to evaluate the effectiveness of erlotinib compared with a placebo sugar pill following complete surgical removal of the tumor with or without chemotherapy after surgery in Stage IB-IIIA NSCLC patients.
After the initiation of the study, the sponsor became aware of an error in the drug dispensing module of the interactive voice response such that most patients who were randomized prior to 07 November 2007 were dispensed the incorrect study drug at least once. Since the integrity of the data from these patients was seriously compromised, these patients were considered unevaluable for the protocol-specified analyses. These participants are referred to as the breached protocol cohort (BPC) and those still on study treatment at the time of the breach were offered the option of receiving open-label erlotinib for up to 2 years (including posttreatment and long-term follow-up assessments), not receiving open-label erlotinib but remaining in the study for posttreatment and long-term follow-up assessment, or withdrawing consent from treatment and further assessments. Participants who had discontinued study treatment prior to the breach were not offered open-label erlotinib and remained in long-term follow-up. Data from the BPC participants were analyzed separately and were not included in the assessments of primary or secondary endpoints in the randomized cohort and were not considered part of the primary analyses.The sample size for the randomized cohort was not changed due to the BPC and the data from RC and BPC were analyzed separately.
Inclusion Criteria:
Primary tissue from patient's surgery must be epidermal growth factor receptor (EGFR)-positive by certain tests
Patients may have up to 4 cycles of chemotherapy after surgery
Complete removal of the tumor by surgery
Able to start drug under the following timelines:
Confirmed diagnosis of Stage IB-IIIA NSCLC
Patients must be accessible for follow-up visits
Exclusion Criteria:
Palm Springs, California 92262, United States
San Francisco, California 94143-1770, United States
Canadaigua, New York 14424, United States
New York, New York 10065, United States
Cary, North Carolina 27511, United States
Christiansburg, Virginia 24073, United States
Roanoke, Virginia 24014, United States
Wytheville, Virginia 24382, United States
Rosario, Santa Fe, S2001SBL, Argentina
East Bentleigh, Victoria 3165, Australia
Salzburg, 5020, Austria
Ostrava-Poruba, 70852, Czechia
Clermont-Ferrand, 63003, France
Muenchen-Gauting, 82131, Germany
Pécs, 7623, Hungary
Szombathely, 9700, Hungary
Poznan, 60-569, Poland
Wroclaw, 53-439, Poland
Arkhangelsk, 163045, Russia
Krasnodar, 350086, Russia
Moscow, 105229, Russia
Moscow, 115478, Russia
Saint Petersburg, 197022, Russia
Saint Petersburg, 197758, Russia
Saint Petersburg, 198255, Russia
Tomsk, 634050, Russia
Yaroslavl, 150040, Russia
Lecester, LE1 5WW, United Kingdom
Leeds, LS9 7TF, United Kingdom