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
Final Accrual:
94 Patients
Protocol Release Date: August 2015 / AMD1 July 2016 / AMD2 July 2017
Trial Activation Date: 24 July 2015
First Patient In: 25 November 2015
Accrual Closure Date: 13 Februray 2019
Global Trial Completion Date: 13 February 2020

Trial Organisation

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

EudraCT number: 2014-005097-11

ClinicalTrials.gov: NCT02434081



ETOP IBCSG Partners Foundation
Effingerstrasse 33
3008 Bern, Switzerland
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