Report Buyer, the online destination for business intelligence for major industry sectors, has added a new report showing that the FDA (Centre for Drug Evaluation and Research) has approved the design of a single, pivotal, Phase III trial evaluating its lead molecule, talactoferrin alfa, in combination with chemotherapy as first-line treatment in patients with non-small cell lung cancer under the special protocol assessment process.

Non-Small-Cell Lung Cancer or Lung Cancer or Small Cell Lung Cancer Drug Pipeline Report reports that The Phase III, multinational, randomised, double-blind, placebo-controlled study will enroll 1,100 previously untreated patients with Stage IIIB or IV non-small cell lung cancer (NSCLC).

 The authors of the report note that the patients will be randomly assigned to receive up to six cycles of standard chemotherapy (carboplatin and paclitaxel) plus either an oral talactoferrin or a placebo.

 They further note that following six cycles of chemotherapy, or discontinuation prior to six cycles for reasons other than progression, patients will receive talactoferrin or placebo as maintenance therapy until disease progression. Progression-free survival and overall survival will be the primary endpoints for accelerated approval and regular approval, respectively. Secondary endpoints include adverse event reductions, confirmed response rate, duration of response and safety.

The report shows that the European Medicines Agency (EMEA) indicates that this single trial will also support a marketing authorisation application in the EU.

Non-Small-Cell Lung Cancer or Lung Cancer or Small Cell Lung Cancer Drug Pipeline Report 

Report Buyer product ID: LSA02156
Report Buyer category: Pharma & Healthcare