CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 94 enrolled
Drug / intervention
Nivolumabdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02434081
NCT02434081Phase 2Completed

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

ETOP IBCSG Partners Foundation·interventional·Posted May 5, 2015·Updated Aug 24, 2022

In Brief

A Phase 2 clinical trial evaluating Nivolumab for Non-small Cell Lung Cancer Stage III. Completed, enrolled 94 participants across 11 sites in 5 countries.

Detailed Summary

The aim of the study is to investigate the tolerability (how severe the side effects are) and the efficacy (how well the treatment works) when nivolumab is added to the current standard treatment (chemotherapy and radiotherapy) given to patients with advanced NSCLC.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Germany, Netherlands, Spain, Switzerland

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 5, 2015
Enrollment StartNov 25, 2015
Primary CompletionFeb 29, 2020
Study CompletionMar 31, 2020
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 11.2 years ago

Interventions

Nivolumabdrug

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.