A feasibility trial evaluating the addition of anti-PD-1 nivolumab to standard first-line chemotherapy and radiotherapy in locally advanced stage IIIA/B Non-Small Cell Lung Carcinoma

NICOLAS: NIvolumab COnsolidation with standard first-line chemotherapy and radiotherapy in Locally Advanced Stage IIIA/B Non-Small Cell Lung Carcinoma

Concomitant chemotherapy and radiotherapy is the first treatment choice for most patients with stage III non-small-cell lung carcinoma (NSCLC). However, only about 30% of patients are alive 5 years after concomitant therapy and there is an unmet need to identify new treatment options in order to improve the prognosis of patients diagnosed with locally advanced NSCLC. Based on the good results in advanced disease, immunotherapy provides a very promising approach. The monoclonal antibody nivolumab is an immune-checkpoint inhibitor that prevents the interaction between the PD-1 receptor and its ligands.

The aim of the NICOLAS trial is to assess the safety and efficacy of nivolumab when administered concurrently to standard first-line chemo-radiotherapy in locally advanced stage IIIA/B NSCLC.

Trial Scheme 

NICOLAS trial design AMD1 

 

Primary endpoint: Grade > 3 pneumonitis
Key-secondary endpoint:  
1-Year progression-free survival
Secondary endpoints

Time to first pneumonitis

Objective response rate

Time to treatment failure

Overall survival

Toxicities of treatment

Target Sample Size: 94 Patients
Trial Status: Suspended, closed to accrual
Protocol Release: August 2015
 Amendment 1: July 2016
Amendment 2: July 2017
Amendment 3: under development

Trial Organisation

Trial Chairs: Solange Peters and Dirk De Ruysscher
Sponsor: ETOP
Coordinating Groups: ETOP
Participating Countries:
Belgium, Germany, Netherlands, Spain and Switzerland
Registrations:

EudraCT number: 2014-005097-11

ClinicalTrials.gov: NCT02434081

Contact:

Lucie Mlejnkova (Trial Manager)
Tel: +41 31 511 94 45
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European Thoracic Oncology Platform
c/o IBCSG
Effingerstrasse 40
3008 Bern, Switzerland
Tel: +41 31 511 94 00