S1403, Afatinib Dimaleate With or Without Cetuximab in Treating Patients With Newly Diagnosed Stage IV or Recurrent, EGFR Mutation Positive Non-small Cell Lung Cancer
Lay Description
This randomized phase II/III trial studies how well afatinib dimaleate with cetuximab works and compares it with afatinib dimaleate alone in treating patients with newly diagnosed stage IV or recurrent (has come back), epidermal growth factor receptor (EGFR) mutation positive non-small cell lung cancer. Afatinib dimaleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cetuximab, may block tumor growth in different ways by targeting certain cells. It is not yet known whether afatinib dimaleate is more effective when given alone or with cetuximab in treating patients with non-small cell lung cancer.
Category
- Cancers and Other Neoplasms
- Lungs, Breathing and Bronchial
- IRB Number
- 20150454HU
- NCT Number
- NCT02438722
- Open to Enrollment
- Yes
Eligibility
- Eligible Ages
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
Exclusion Criteria
Study Design
Arm Groups
Study Contact
Frances Crawford
(210) 450-5037
crawfordf1@uthscsa.edu
Sonia Creighton
(210) 450-1366
creighton@uthscsa.edu
Anand Karnad
(210) 450-1667
karnad@uthscsa.edu
Myrna Montenegro
(210) 450-5954
montenegro@uthscsa.edu
Courtney Nichols
(210) 450-1794
nicholsc2@uthscsa.edu
Mailbox Ctrc Regulatory Affairs
regaffapp@uthscsa.edu
Regulatory Staff
regaffstaff@uthscsa.edu
Kathleen Rodriguez
(210) 450-1365
rodriguezk3@uthscsa.edu
Benjamin Schleif
(210) 450-1366
schleifb@uthscsa.edu
Morgan Seekatz
(210) 450-1133
seekatz@uthscsa.edu
Mailbox Ctrc Regulatory Affairs
regaffapp@uthscsa.edu
Principal Investigator
Anand Karnad