Neoadjuvant Erlotinib for Operable Stage II or IIIA NSCLC With EGFR Mutations
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|ClinicalTrials.gov Identifier: NCT01470716|
Recruitment Status : Active, not recruiting
First Posted : November 11, 2011
Last Update Posted : April 6, 2022
|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|
|Actual Study Start Date :||January 2012|
|Actual Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||June 30, 2022|
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01470716
|Korea, Republic of|
|National Cancer Center|
|Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769|
|Principal Investigator:||Ji-Youn Han, M.D. PhD.||National Cancer Center|