Neoadjuvant Erlotinib for Operable Stage II or IIIA NSCLC With EGFR Mutations
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01470716|
Recruitment Status : Recruiting
First Posted : November 11, 2011
Last Update Posted : August 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|NSCLC Stage II NSCLC, Stage IIIA||Drug: Erlotinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2020|
Experimental: Study arm
Neo-adjuvant Erlotinib treatment arm.
Neo-adjuvant Erlotinib treatment during maximum 8 weeks.
Other Name: treatment arm
- Progression-Free survival [ Time Frame: every 8 week ]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 ]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 ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01470716
|Contact: JI-YOUN HAN, M.D. PhD.||+firstname.lastname@example.org|
|Contact: SUNG JIN YOON, R.N.||+email@example.com|
|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 firstname.lastname@example.org|
|Contact: Sung Jin Yoon, RN +82-31-920-0405 email@example.com|
|Principal Investigator:||Ji-Youn Han, M.D. PhD.||National Cancer Center|