At a glance
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A Randomized, Phase II Study of Staggered, Chemo-Immunotherapy With Durvalumab, MEDI4736 Pemetrexed and Carboplatin (PC) for Metastatic Non-Squamous NSCLC
In Brief
A Phase 2 clinical trial evaluating Durvalumab, Pemetrexed, and 1 other intervention for Non-Small Cell Lung Cancer Metastatic. Active but no longer recruiting, targeting 43 participants across 1 site.
Detailed Summary
This is a Phase II, open label, randomized study of durvalumab in combination with pemetrexed and carboplatin in eligible adult patients with locally advanced or metastatic non-small cell lung cancer. The study will focus on the efficacy of two alternative staggered dosing regimens.
Study Details
Timeline
Interventions
Durvalumab is administered at a dose of 1500mg for patients who weigh \>30 kg. If weight falls to ≤ 30 kg, weight-based dosing at 20mg/kg will be a utilized
Pemetrexed dosing is adjusted for kidney function. Pemetrexed is dosed at 500mg/m2 for patients with a creatinine clearance ≥ 45 mL/min (by Cockcroft-Gault formula). If creatinine clearance is \< 45 mL/min, pemetrexed is dosed at 400 mg/m2.
Carboplatin dosing is adjusted for kidney function.The total dose (in mg) of carboplatin will be calculated using the Calvert Formula utilizing a target AUC of 5 and a patient's GFR in mL/min.