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news.US-based OncoMed Pharmaceuticals has started dosing in its double-blinded, placebo-controlled, randomized Phase II DENAL clinical trial of demcizumab (anti-DLL4, OMP-21M18) to treat patients with first-line advanced-stage non-small cell lung cancer (NSCLC).
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Around 200 patients with first-line metastatic Stage IV non-squamous NSCLC whose tumors do not have an epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutation will be enrolled in the trial, which will be conducted at about 60 sites in Europe, the US and Australia.
During the trial, patients will be randomized into one of three arms to compare the efficacy and safety of demcizumab combined with carboplatin and pemetrexed versus carboplatin and pemetrexed alone.
The company said that in all three arms, patients will be given carboplatin and pemetrexed for four cycles, followed by pemetrexed maintenance.
Additionally, patients in the first arm will receive the chemotherapy plus placebo, patients in second arm will receive chemotherapy with one truncated course of demcizumab every three weeks for four doses.
Patients in the third arm will receive chemotherapy with two truncated courses of demcizumab with the second truncated course starting at Day 168.
The trial’s primary endpoint is progression-free survival (PFS), while secondary endpoints include response rate, duration of response, overall survival, safety, immunogenicity and pharmacokinetics.
The Phase Ib clinical trial of demcizumab in NSCLC has showed that the combination of demcizumab with pemetrexed and carboplatin was generally well tolerated.