Afatinib In Combination With Cisplatin Or Carboplatin + Pemetrexed In Patients With EGFR-Mutant Lung Cancers Undergoing Definitive Chemoradiation
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01836341|
Recruitment Status : Withdrawn
First Posted : April 19, 2013
Last Update Posted : December 19, 2013
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Drug: Afatinib Drug: Cisplatin Drug: Carboplatin Drug: Pemetrexed Radiation: Radiation therapy||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Dose-Finding Study Of Afatinib In Combination With Cisplatin Or Carboplatin + Pemetrexed In Patients With EGFR-Mutant Lung Cancers Undergoing Definitive Chemoradiation|
|Study Start Date :||April 2013|
|Estimated Primary Completion Date :||April 2015|
|Estimated Study Completion Date :||April 2015|
Experimental: Afatinib w Cisplatin Pemetrexed Chemoradiation
induction afatinib 40mg daily x 28days Cisplatin or Carboplatin (can be used if patient is not eligible for cisplatin) + Pemetrexed + 50Gy to pretreatment field boost to 60Gy to residual tumor + afatinib dose escalation*
*afatinib dose levels: 20mg daily, 30mg daily & 40mg daily (3+3 design) Then adjuvant afatinib x 2 years
Radiation: Radiation therapy
- maximum tolerated dose [ Time Frame: 1 year ]This will be defined as the dose at which fewer than 1:6 patients experiences a dose-limiting toxicity.
- local control rate [ Time Frame: at 1 year and at 2 years ]will be determined as the proportion of patients who start the concurrent phase who are alive and free of local failure.
- tolerability of adjuvant afatinib [ Time Frame: at 3 months ]Tolerability will be defined by in terms of dose reductions, delays and discontinuations of patients who have not had disease progression or death.
- median progression free survival [ Time Frame: 2 years ]PFS is defined as the duration of time from start of treatment to time of progression of disease or death, whichever occurs first.
- median overall survival [ Time Frame: 2 years ]will be calculated using Kaplan-Meier estimates among all patients enrolled.
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): NCT01836341
|Principal Investigator:||Jamie E. Chaft, MD||Memorial Sloan Kettering Cancer Center|