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news.Roche and the Spanish Lung Cancer Group, a non-profit co-operative group, have announced their collaboration on the first Phase III trial to investigate Tarceva in lung cancer patients with genetic mutations in their epidermal growth factor receptor.
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The Eurtac trial is the first prospective, randomized Phase III trial to investigate whether first line treatment with Tarceva is superior to chemotherapy in patients with epidermal growth factor receptor (EGFR) mutation positive disease, said Roche.
Tarceva has already been shown to significantly extend survival and the time patients with advanced lung cancer live without their cancer getting worse and without the side effects associated with chemotherapy, the company noted. The results from Eurtac, if positive, will support a submission by Roche to the European Medicines Agency to seek an additional new indication for use of Tarceva.
Rafael Rosell from the Spanish Lung Cancer Group (SLCG) said: “Clinical evidence has already shown a dramatic response to Tarceva among lung cancer patients with mutations on the EGFR gene. The Phase III Eurtac trial will evaluate whether Tarceva is a superior option for initial treatment of lung cancer patients with EGFR mutation positive disease than chemotherapy.”