Femme et Homme
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Extrait
Phase 1 (Safety Run-in Phase): • To evaluate the safety and tolerability of INCB039110 in combination with erlotinib and select a dose for further evaluation. Phase 2 (Randomized Phase): • To evaluate and compare the OS and PFS of subjects with Stage IIIB/IV or recurrent NSCLC whose tumors have EGFR-activating mutations when treated with INCB039110 in combination with erlotinib versus erlotinib alone.
Critère d'inclusion
- Male or female individuals, aged 18 years or older who have Stage IIIB/IV or recurrent NSCLC. Subjects must have tumors that are positive for EGFR-activating mutation, namely, exon 19 deletions, exon 21 L858R mutations, or point mutations at position 719. Enrolled subjects must have a life expectancy of at least 12 weeks and have adequate liver, kidney, and bone marrow function