Afatinib In Combination With Cisplatin Or Carboplatin + Pemetrexed In Patients With EGFR-Mutant Lung Cancers Undergoing Definitive Chemoradiation
|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Recruitment Status : Withdrawn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
|Drug: Afatinib Drug: Cisplatin Drug: Carboplatin Drug: Pemetrexed 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01836341
|Principal Investigator:||Jamie E. Chaft, MD||Memorial Sloan Kettering Cancer Center|