Multicenter Phase II Study Evaluating Two Cycles of Docetaxel, Cisplatin and Cetuximab as Induction Regimen Prior to Surgery in Chemotherapy-Naive Patients with NSCLC Stage IB-IIIA (INN06-Study)

<div><p>Background</p><p>Different strategies for neoadjuvant chemotherapy in patients with early stage NSCLC have already been evaluated. The aim of this study was to evaluate the tolerability and efficacy of a chemoimmunotherapy when limited to two cycles.</p><p>Methods</p><p>Between 01/2007 and 03/2010 41 patients with primarily resectable NSCLC stage IB to IIIA were included. Treatment consisted of two cycles cisplatin (40 mg/m² d1+2) and docetaxel (75 mg/m² d1) q3 weeks, accompanied by the administration of cetuximab (400 mg/m² d1, then 250 mg weekly). The primary endpoint was radiological response according to RECIST.</p><p>Results</p><p>40 patients were evaluable for toxicity, 39 for response. The main grade 3/4 toxicities were: neutropenia 25%, leucopenia 11%, febrile neutropenia 6%, nausea 8% and rash 8%. 20 patients achieved a partial response, 17 a stable disease, 2 were not evaluable. 37 patients (95%) underwent surgery and in three of them a complete pathological response was achieved. At a median follow-up of 44.2 months, 41% of the patients had died, median progression-free survival was 22.5 months.</p><p>Conclusions</p><p>Two cycles of cisplatin/ docetaxel/ cetuximab showed promising efficacy in the neoadjuvant treatment of early-stage NSCLC and rapid operation was possible in 95% of patients. Toxicities were manageable and as expected.</p><p>Trial Registration</p><p>EU Clinical Trials Register; Eudract-Nr: <a href="https://www.clinicaltrialsregister.eu/ctr-search/search?query=2006-004639-31" target="_blank">2006-004639-31</a></p></div

Participant diagram.

<p>Paricipant diagram describing patients analyzed in the INN-06 study.</p

Baseline demographics and clinical characteristics (n = 39).

<p>“Clinical staging” included CT only.</p><p>*“Comprehensive staging” included CT, PET, MSC or EBUS.</p><p>Baseline demographics and clinical characteristics (n = 39).</p

Adverse Events (n = 40).

<p>Adverse Events (n = 40).</p