Neoadjuvant Erlotinib for Operable Stage II or IIIA NSCLC With EGFR Mutations
This study examines preoperative Erlotinib in patients with operable stage II and IIIA Non-small-cell lung cancer (NSCLC) harboring EGFR mutations.
Non-small Cell Lung Cancer Stage II
Non-small Cell Lung Cancer Stage IIIA
Epithelial Growth Factor Receptor Positive Non-small Cell Lung Cancer
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Neo-adjuvant Erlotinib for Operable Stage IIB or IIIA Non-small Cell Lunc Cancer With Epidermal Growth Factor Receptor Activation Mutations|
- Progression-Free survival [ Time Frame: every 8 week ] [ Designated as safety issue: No ]Progression free survival will be calculated from the date of study treatment start to the first objective documentation of progressive disease or to the date of death, whichever occurs first.
- Response rate [ Time Frame: every 4 weeks ] [ Designated as safety issue: No ]The response rate will be determined by the number of patients with complete and partial responses according to RECIST criteria 1.1
- Overall Survival Rate [ Time Frame: every 3months, until death ] [ Designated as safety issue: No ]Survival time will be calculated from the date of study treatment start to the date of death.( or date last seen )
- Toxicity profile [ Time Frame: Every 4 weeks ] [ Designated as safety issue: Yes ]Safety will be evaluated by the frequency, severity, and relationship of adverse event graded by NCI Common Toxicity Criteria version 4.0 that occur during the treatment and follow up periods.
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||September 2015|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Experimental: Study arm
Neo-adjuvant Erlotinib treatment arm.
Neo-adjuvant Erlotinib treatment during maximum 8 weeks.
Other Name: treatment arm
Lung cancer remains the most common cause of cancer-related death in the world. Non-small-cell lung cancer (NSCLC) is the most common type, and it accounts for 85% of cases. Unfortunately, the majority of patients with NSCLC have metastatic disease at diagnosis. However, even patients with resectable disease have poor survival. The need to improve survival rates in these patients prompted research exploring the role of systemic therapy in operable NSCLC. In the 1990s, several clinical trials of preoperative chemotherapy (also known as induction chemotherapy) followed by surgery or radiation in patients with locally advanced NSCLC showed improvements in survival. Erlotinib is an orally administered tyrosine kinase inhibitor of the epidermal growth factor receptor (EGFR). The presence of somatic mutations in the kinase domain of EGFR strongly correlates with increased responsiveness to EGFR tyrosine kinase inhibitors. Recently three randomized phase III trials showed that first-line use of EGFR-TKIs in patients with EGFR mutant NSCLC significantly improved response rate and progression-free survival (PFS) compared to platinum-based chemotherapy. These findings prompted this phase II trial of preoperative Erlotinib in patients with operable stage II and IIIA NSCLC harboring EGFR mutations.
|Contact: JI-YOUN HAN, M.D. PhD.||+email@example.com|
|Contact: SUNG JIN YOON, R.N.||+firstname.lastname@example.org|
|Korea, Republic of|
|National Cancer Center||Recruiting|
|Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769|
|Contact: Ji-youn Han, M.D., Ph.D. +82-31-920-1154 email@example.com|
|Contact: Sung Jin Yoon, RN +82-31-920-0405 firstname.lastname@example.org|
|Principal Investigator:||Ji-Youn Han, M.D. PhD.||National Cancer Center|