Spots Global Cancer Trial Database for Induction Therapy With Intercalated Tyrosine Kinase Inhibitor (TKI) and Chemotherapy in NSCLC With Activating Epidermal Growth Factor Receptor (EGFR) Mutation in Stages II-IIIB

Study Description

Brief Summary: This study is designed as a single arm, un-controlled, open-label, multi-center hypothesis generating two-stage phase II trial. It is based on the assumption that the proposed treatment scheme doubles the rate of pathologic complete remission in Mutated epidermal growth factor receptor (EGFRmt) + NSCLC patients compared to historical control data from standard treatments. Patients with NSCLC and activating EGFR mutation in stages II, IIIA and IIIB eligible for induction therapy with docetaxel and cisplatin and 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.

Detailed Description: Based on the notion that neoadjuvant combination of Chemotherapy (CTx) and intercalated TKI is clinically beneficial, which can be inferred from prior study data and single case reports, this study aims to generate additional information on feasibility, safety and efficacy of this treatment approach in a larger group of EGFR mutated NSCLC patients. This study is a hypothesis generating two-stage trial for future phase III studies of neoadjuvant CTx with intercalated TKI. Hence, the study design relies entirely on a single treatment arm. To demonstrate efficacy it is sufficient to compare to historical data of the conventional treatments of NSCLC.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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