This research study is studying a combination of drugs as a possible treatment for EGFR mutation-positive lung cancer. The drugs involved in this study are: - EGF816 - Gefitinib
Name: EGF816
Description: EGF816 is an inhibitor which target a specific mutation in cancer and may stop tumors growing and multiplyingType: DrugEGF816 + Gefitinib
Name: Gefitinib
Description: Gefitinib is an inhibitor which target a specific mutation in cancer and may stop tumors growing and multiplyingType: DrugEGF816 + Gefitinib
Description: The number of participants that are free from objective disease progression or death at 9 months. Progression is evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
Measure: Progression Free Survival at 9 months Time: 9 monthsDescription: The number of participants that achieve either a complete response (CR) or a partial response (PR). Response is evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. All CRs and PRs must be confirmed by a second assessment not earlier than 4 weeks after the criteria for response are first met.
Measure: Response Rate Time: 2 yearsDescription: Overall survival is defined as time from the start of treatment until death. Overall survival will be analyzed using the Kaplan-Meier method.
Measure: Overall Survival Time: 2 yearsDescription: Summary of the adverse events experienced by study participants as evaluated by Common Terminology Criteria for Adverse Events (CTCAE) v4.
Measure: Safety and Tolerability of the EGF816/gefitinib combination (Summary of the adverse events experienced by study participants as evaluated by CTCAE v4) Time: 2 yearsSingle Group Assignment
There is one SNP
Specifically, patients harboring the most common mutations, deletions in exon 19 or the L858R mutation in exon 21 are eligible. --- L858R ---