Table 1.

EGFR Inhibitors in Phase III Development for the Treatment of NSCLC

Agent	Binding	Target(s)	Clinical setting	ClinicalTrials.gov identifier (status as of August 2010)
EGFR TKIs
Afatinib (BIBW 2992)	Irreversible	EGFR, HER2	Phase III trial of afatinib as first-line therapy versus pemetrexed/cisplatin in patients with confirmed EGFR-activating mutations (LUX-Lung 3)	NCT00949650 (recruiting)
			Phase III trial of afatinib in combination with paclitaxel versus single-agent chemotherapy (chosen by the investigator) in patients with progressive disease after treatment with chemotherapy⁎ and erlotinib or gefitinib who subsequently received benefit from afatinib monotherapy (LUX-Lung 5)	NCT01085136 (recruiting)
			Phase III trial of afatinib versus gemcitabine/cisplatin in patients with NSCLC harboring an EGFR mutation (LUX-Lung 6)	NCT01121393 (recruiting)
PF00299804	Irreversible	EGFR, HER2, HER4	Phase III trial of PF00299804 compared with placebo in patients with stage IIIB or IV NSCLC after failure of standard therapy for advanced or metastatic disease	NCT01000025 (recruiting)
EGFR monoclonal antibody
Cetuximab	Reversible	EGFR	Phase III trial of cisplatin/vinorelbine with or without cetuximab as first-line treatment of patients with advanced NSCLC (FLEX)	NCT00148798 (active but not recruiting†)
			Phase III trial of docetaxel or pemetrexed with or without cetuximab in patients with recurrent or progressive NSCLC	NCT00095199 (active but not recruiting)
			Phase III trial of cetuximab as maintenance therapy after platinum-based chemotherapy in combination with cetuximab as first-line treatment of patients with advanced NSCLC (NEXT)	NCT00820755 (active but not recruiting)
			Phase III trial of high-dose or standard-dose radiation therapy in combination with chemotherapy with or without cetuximab in patients with newly diagnosed, unresectable, stage III NSCLC	NCT00533949 (recruiting)
			Phase III trial of carboplatin and paclitaxel with or without bevacizumab and/or cetuximab in patients with stage IV or recurrent NSCLC	NCT00946712 (recruiting)

BSC, best supportive care; EGFR, epidermal growth factor receptor; HER, human epidermal growth factor receptor; NSCLC, non–small cell lung cancer; TKI, tyrosine kinase inhibitor.

^⁎Patients are exempt from prior chemotherapy if they have a confirmed EGFR mutation or had ≥6 months of benefit from erlotinib or gefitinib.

^†Favorable results have been published.¹⁴