NIvolumab COmbination With Standard First-line Chemotherapy and Radiotherapy in Locally Advanced Stage IIIA/B Non-Small Cell Lung Carcinoma

Sponsor
ETOP IBCSG Partners Foundation
Study ID
NCT02434081
Phase
PHASE2
Status
Completed

Conditions

  • Non-small Cell Lung Cancer Stage III

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Nov 25, 2015
Status verified
Aug 2022
Primary completion
Feb 29, 2020
Completion
Mar 31, 2020

Study Design

Enrollment
94 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Grade ≥3 Pneumonitis (CTCAE v4.0) up to 6 Months Post-radiotherapy [ Time Frame: Time from enrolment until 6 months post-radiotherapy ]

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