NCT01714037 - A Clinical Study on the Safety and Efficacy of Debio 0932 in Combination With Standard of Care in Patients With Non-small Cell Lung Cancer [NSCLC] | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

August 31, 2012

Primary Completion Date

November 30, 2014

Study Completion Date

November 30, 2014

Conditions

Non-small Cell Lung Cancer

Interventions

DRUG

Debio 0932

Debio 0932 will be administered as daily oral tablets at a starting dose of 250 mg four times per day (QD).

DRUG

Cisplatin

Cisplatin 75 mg/m2 body surface area (BSA) will be administered on Day 1 of each 21-day treatment cycle.

DRUG

Pemetrexed

Pemetrexed 500 mg/m2 BSA will be administered on Day 1 of each 21 day treatment cycle.

DRUG

Gemcitabine

Gemcitabine 1250 mg/m2 BSA will be administered on Days 1 and 8 of each 21-day treatment cycle.

DRUG

Docetaxel

Docetaxel 60 or 75 mg/m2 BSA will be administered on Day 1 of each 21-day treatment cycle.

Trial Locations (8)

Centre GF Leclerc, Dijon

Centre Léon Bérard, Lyon

Institut de Cancérologie de l'Ouest- Institut René Gauduchau, Nantes

Institut Claudius Regaud, Toulouse

Hospital Universitari Vall d'Hebron, Barcelona

Hospital Puerta de Hierro Majadahonda, Madrid

Hospital Universitario Virgen del Rocío, Seville

Freeman Hospital, Newcastle