NCT00349219

TORCH: A Study of Tarceva or Chemotherapy for the Treatment of Advanced Non Small Cell Lung Cancer

An International Randomized Phase III Study of First-line Erlotinib Followed by Second-line Cisplatin + Gemcitabine Versus First-line Cisplatin + Gemcitabine Followed by Second-line Erlotinib in Advanced Non Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 760 (actual)
• Sponsor: National Cancer Institute, Naples · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare first-line erlotinib followed at progression by second-line chemotherapy vs. first-line chemotherapy followed at progression by second-line erlotinib in the treatment of Advanced Non Small Cell Lung Cancer (NSCLC).

Detailed description

Chemotherapy for patients affected by advanced NSCLC has demonstrated only modest improvement in survival rates over best supportive care: the prognosis of patients remains poor and the side effects are considerable. Therefore, novel agents are urgently needed for this disease. One way to improve effectiveness of therapies is to use non-chemotherapeutic agents that act on biological targets and cause fewer systemic side effects. Erlotinib(Tarceva)is a biological therapy that in recent clinical trials has shown promise in first- and second-line treatment of advanced NSCLC. In this trial, patients will be randomized to one of two treatment strategies: \- erlotinib taken by mouth daily; and, if disease progression occurs, to be followed by chemotherapy with cisplatin and gemcitabine at standard doses for 6 cycles OR \- chemotherapy with cisplatin and gemcitabine given intravenously at standard doses for 6 cycles; and if disease progression occurs to be followed by erlotinib taken by mouth daily The study is conducted with the partial support of Roche, S.p.A.

Conditions

• Advanced Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	erlotinib	erlotinib 150 mg taken orally daily until disease progression
DRUG	cisplatin	cisplatin 80 mg/m2 IV day 1 every 3 weeks given in second-line therapy
DRUG	gemcitabine	gemcitabine 1200 mg/m2 IV days 1 and 8 every 3 weeks, given in second-line
DRUG	cisplatin	cisplatin 80 mg/m2 IV day 1 every 3 weeks for 6 cycles
DRUG	gemcitabine	gemcitabine 1200 mg/m2 IV days 1 and 8 every 3 weeks for 6 cycles
DRUG	erlotinib	erlotinib 150 mg orally taken daily as second line therapy (after disease progression on chemotherapy)

Timeline

• Start date: 2006-12-01
• Primary completion: 2011-12-01
• Completion: 2012-06-01
• First posted: 2006-07-06
• Last updated: 2016-01-15

Locations

73 sites across 2 countries: Canada, Italy