Research presented at the American Society of Clinical Oncology Annual Meeting in June included these two clinical trials in advanced, metastatic non-small cell lung cancer (NSCLC).
Ipilimumab With Paclitaxel/Carboplatin
This phase III study trial will compare the efficacy of phased ipilimumab with paclitaxel/carboplatin versus placebo with paclitaxel/carboplatin for the treatment of stage IV/recurrent NSCLC of squamous histology.
Despite extensive research, outcomes for this subtype have not improved beyond those of standard platinum doublets. Patients will be randomized to receive two cycles of paclitaxel/carboplatin (175 mg/m2 and AUC = 6, respectively; IV), followed by four cycles of study drug with four additional cycles of paclitaxel/ carboplatin for a total of six cycles.
Patients without progressive disease after induction receive maintenance therapy with the blinded study drug every 12 weeks until they have evidence of progressive disease per World Health Organization criteria. The primary endpoint is overall survival (OS). Secondary endpoints include OS among patients who receive blinded therapy, progression-free survival (PFS), and best overall response rate.
Bristol-Myers Squibb is sponsoring the study (ClinicalTrials. gov Identifier: NCT01285609).
Onartuzumab Plus Erlotinib
This phase III study will compare onartuzumab plus erlotinib versus placebo plus erlotinib in patients with advanced, MET-positive NSCLC.
Onartuzumab is a humanized, monovalent monoclonal antibody that binds to MET with high specificity, preventing HGF ligand binding and blocking downstream signaling.
Patients are eligible provided they have MET diagnostic-positive tumors and have failed at least one but no more than two prior lines of platinum-based chemotherapy for advanced disease. Following stratification for MET expression, prior lines of therapy, histology, and epidermal growth factor receptor (EGFR
)-activating mutation status, patients are randomized to erlotinib (150 mg PO daily) plus placebo or onartuzumab (15 mg/kg IV Q3W) until they have disease progression or unacceptable toxicity or death or if they decide with their physician to drop out of the study.
The primary endpoint is OS. Secondary endpoints include PFS, response rates, safety, patient-reported outcomes, and pharmacokinetics.
Genentech is sponsoring the trial (NCT01456325).
Beck M, Lu H, Gribkoff G, et al. CA184-104: randomized, multicenter, double-blind, phase III trial comparing the efficacy of ipilimumab (Ipi) with paclitaxel/carboplatin (PC) versus placebo with PC in patients (pts) with stage IV/recurrent non-small cell lung cancer (NSCLC) of squamous histology. J Clin Oncol. 2012;30(suppl; abstr TPS7611).
Spigel DR, Edelman MJ, Mok T, et al. The MetLUNG study: a randomized, double-blind, phase III study of onartuzumab (MetMAb) plus erlotinib versus placebo plus erlotinib in patients with advanced, MET-positive non-small cell lung cancer (NSCLC). J Clin Oncol. 2012;30(suppl; abstr TPS7616).