NIvolumab COmbination With Standard First-line Chemotherapy and Radiotherapy in Locally Advanced Stage IIIA/B Non-Small Cell Lung Carcinoma (NICOLAS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02434081|
Recruitment Status : Active, not recruiting
First Posted : May 5, 2015
Last Update Posted : March 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer Stage III||Drug: Nivolumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||94 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial Evaluating the Safety and Efficacy of the Addition of Concurrent Anti-PD 1 Nivolumab to Standard First-line Chemotherapy and Radiotherapy in Locally Advanced Stage IIIA/B Non-Small Cell Lung Carcinoma|
|Actual Study Start Date :||November 2015|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||August 2020|
Experimental: Chemo-radiotherapy with concurrent nivolumab
4 doses of nivolumab 360mg concurrently with standard chemo-radiotherapy, followed by 480mg for up to 1 year from start of nivolumab treatment.
Nivolumab is a fully human monoclonal antibody that targets the programmed death-1 (PD-1) cell surface membrane receptor. PD-1 is a negative regulatory molecule expressed by activated T and B lymphocytes.Binding of PD-1 to its ligands, 1 (PD-L1) and 2 (PD-L2), results in the down-regulation of lymphocyte activation. Nivolumab inhibits the interaction of programmed cell death Protein 1 (PD-1)with its ligands, PD-L1 and PD-L2, resulting in enhanced T-cell proliferation.
Other Name: BMS-936558
- Grade ≥3 pneumonitis (CTCAE v4.0) from the end of radiotherapy [ Time Frame: Observed any time during 6 months from the end of radiotherapy. ]It is defined as the number of patients reaching up to 6 months post chemo-radiation treatment without any episode of CTCAE v4.0 grade ≥3 pneumonitis. It will be used as the primary endpoint for all patients followed for at least 6 months beyond radiotherapy.
- 1-year progression-free survival by RECIST v1.1 (PFS) [ Time Frame: Up to 1 year - time from the date of enrolment until documented progression or death, if progression is not documented. ]Key secondary endpoint
- Time to first pneumonitis of grade ≥3 (TFP3) [ Time Frame: Time from the date of enrolment until first documented pneumonitis of grade ≥3, for up to approximately 22 months. ]TFP3 is defined as the time from the date of enrolment until first documented pneumonitis of grade ≥3.
- Objective response [ Time Frame: Determined using RECIST v1.1 criteria. ]Objective response is defined as best overall response (CR or PR) across all assessment timepoints during the period from enrolment to termination of trial treatment.
- Time to treatment failure (TTF). [ Time Frame: Assess at the time of discontinuation of treatment for any reason. ]Time to treatment failure (TTF) is defined as time from enrolment to discontinuation of treatment for any reason, including disease progression, treatment toxicity, and death.
- Overall Survival (OS) [ Time Frame: Time from date of enrolment until death from any cause. ]Defined as time from the date of enrolment until death from any cause.
- Adverse events graded according to CTCAE V4.0 (Toxicity) [ Time Frame: Adverse events will be recorded from enrolment to discontinuation of treatment for any reason. ]Adverse events classified according to CTCAE version 4.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02434081
|University Hospital Leuven|
|Thoracic Oncology Centre Munich|
|Maastricht, Netherlands, 6229 ET|
|Vall d'Hebron University Hospital|
|Barcelona, Spain, 08035|
|Catalan Institute of Oncology|
|Barcelona, Spain, 08907|
|Hospital Virgen de la Salud|
|Toledo, Spain, 45071|
|HFR Fribourg- Hôpital cantonal|
|Fribourg, Switzerland, 1708|
|Winterthur, Switzerland, 8401|
|Hirslanden Klinik Zürich|
|Zurich, Switzerland, 8032|
|University Hospital Zürich|
|Study Chair:||Solange Peters, MD PhD||University of Lausanne Hospitals|
|Study Chair:||Dirk De Ruysscher, MD PhD||Maastro Clinic, Maastricht, The Netherlands|