A Randomized, Double-Blind, Multicenter, Pharmacokinetic Equivalence Clinical Trial of QL2107 (Keytruda® Biosimilar Candidate) in Comparison with Keytruda® (Pembrolizumab) for Adjuvant Therapy to Demonstrate Pharmacokinetic Similarity in Subjects with Resected Non-Small Cell Lung Cancer.

Non-small cell lung cancer

Area under the concentration time curve for 1 dosing interval (tau = 21 days) after a single (initial) dose (AUC tau,sd) of QL2107 and Keytruda® (Cycle 1), Area under the concentration time curve for 1 dosing interval (tau = 21 days) at steady state (AUC tau,ss) of QL2107 and Keytruda® (Cycle 7)

Maximum (peak) serum concentration after a single dose (C max,sd) of QL2107 and Keytruda® (initial dose at Cycle 1)., Maximum (peak) serum concentration at steady state (C max,ss) of QL2107 and Keytruda® (Cycle 7)., The trough serum concentration measured before the next dose is administered (C trough) of QL2107 and Keytruda® (predose samples) at Cycle 2 (Week 4), Cycle 4 (Week 10), Cycle 5 (Week 13), Cycle 6 (Week 16), Cycle 7 (Week 19), Cycle 10 (Week 28) and Cycle 14 (Week 40).

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