NCT02326285 - Induction Therapy With Intercalated Tyrosine Kinase Inhibitor (TKI) and Chemotherapy in NSCLC With Activating Epidermal Growth Factor Receptor (EGFR) Mutation in Stages II-IIIB | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

November 30, 2015

Primary Completion Date

March 28, 2017

Study Completion Date

January 31, 2018

Conditions

Non-squamous Non-small Cell Lung Cancer Stage IINon-squamous Non-small Cell Lung Cancer Stage IIIANon-squamous Non-small Cell Lung Cancer Stage IIIBActivating EGFR MutationNSCLC

Interventions

DRUG

Gefitinib

Patients will be treated for 12 days with gefitinib 250 mg/day p.o. (d -12 to -1) and induced with chemotherapy docetaxel 75 mg/m2 and cisplatin 50 mg/m2 d1+2 and intercalated gefitinib 250 mg/day d4-20 (cycle 1 and 2) and d4-17 (for cycle3). Surgery is planned in the 4th week after d1 of the last cycle.

DRUG

docetaxel

chemotherapy docetaxel 75 mg/m2 and cisplatin 50 mg/m2 d1+2 and intercalated gefitinib 250 mg/day d4-20 (cycle 1 and 2) and d4-17 (for cycle3).

DRUG

cisplatin

chemotherapy docetaxel 75 mg/m2 and cisplatin 50 mg/m2 d1+2 and intercalated gefitinib 250 mg/day d4-20 (cycle 1 and 2) and d4-17 (for cycle3).

PROCEDURE

Surgery

Surgery should be performed in the 4th or at the latest 5th week after d1 of the last cycle of chemotherapy (d64 to 78).

Trial Locations (1)

26121

Pius-Hospital, Oldenburg