ImmunoGen has initiated a Phase I/II clinical trial to evaluate proprietary product candidate IMGN901 (lorvotuzumab mertansine) for first-line treatment of small cell lung cancer in patients with extensive disease.
The multinational trial will compare IMGN901 in combination with carboplatin plus etoposide (C/E) – the standard of care for the first-line treatment of small cell lung cancer –with C/E alone.
In the dose-escalation portion of the Phase I trial, patients will receive increasing doses of IMGN901 with C/E to establish the maximum tolerated dose.
In the Phase II portion, 60 patients will be randomised to receive C/E plus IMGN901, and 30 patients will be randomised to receive C/E alone.
The primary endpoint of the study will be progression-free survival, while secondary endpoints will be longer time-to-progression, overall response rate, overall survival at 12 months and overall survival.