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

Summary

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.

Timeline

Start

2015-05-07

Primary completion

2018-09-25

Completion

2026-04-17

Outcome

Missed primary endpoint

paper There was no improvement in PFS in patients receiving afatinib plus cetuximab compared with afatinib alone PMID 33021871 ↗

paper P = .94; median, 11.9 months v 13.4 months PMID 33021871 ↗

Publications

• Goldberg SB, Redman MW, Lilenbaum R, Politi K, Stinchcombe TE, Horn L, Chen EH, Mashru SH, Gettinger SN, Melnick MA, Herbst RS, Baumgart MA, Miao J, Moon J, Kelly K, Gandara DR. Randomized Trial of Afatinib Plus Cetuximab Versus Afatinib Alone for First-Line Treatment of EGFR-Mutant Non-Small-Cell Lung Cancer: Final Results From SWOG S1403. J Clin Oncol. 2020 Dec 1;38(34):4076-4085. doi: 10.1200/JCO.20.01149. Epub 2020 Oct 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Afatinib	Small molecule	40 mg	Oral
Subject	Cetuximab	Monoclonal antibody	500 mg/m2	Intravenous

Indications