Practicality and safety of direct injection of nivolumab using ultrasound guidance (EBUS) into chest lymph nodes in advanced lung cancer patients

Assessment Of Feasibility And Safety Of Endobronchial Ultrasound Guided Intranodal Immunotherapy With Programmable Death Protein 1 Inhibitor Nivolumab In Patients With Advanced Non-small Cell Lung Carcinoma - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/08/072960

Enrollment

Registered

2024-08-23

Start date

Unknown

Completion date

Unknown

Last updated

2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C348- Malignant neoplasm of overlappingsites of bronchus and lung

Interventions

Intervention1: Intranodal Nivolumab: Endobronchial Ultrasound guided Intranodal Instillation (EBUS- TBNI) of nivolumab in 10mg/ml concentration according to target nodal size A total of two sessions o

Eligibility

Inclusion criteria

Inclusion criteria: Patients with histopathologically proven non-small cell lung carcinoma with significant mediastinal lymphadenopathy on Chest Computed Tomography Non-resectable disease on staging Target mediastinal node size equal to or greater than 2cm Not eligible for oral TKI therapy, and non affording for immunotherapy Patients without contraindications for Endobronchial ultrasound Written informed consent

Exclusion criteria

Exclusion criteria: EBUS Inaccessible mediastinal lymph nodes Not giving written informed consent Poor performance status Patients with a life expectancy of less than four weeks Contraindications to endobronchial ultrasound guided needle aspiration Contraindications to nivolumab or conventional chemotherapy regimens Severe sepsis/septic shock Unstable concurrent medical condition like recent myocardial infarction, recent major surgery Therapeutic anticoagulation Prior receipt of conventional chemotherapy or systemic immunotherapy for current disease

Design outcomes

Primary

Measure	Time frame
Feasibility of TBNI shall be assessed based on successful localization of the target node/lesion, and delivery of at least 80% of the calculated dosage of nivolumab to the accessible lesions/node Timepoint: Feasibility shall be assessed at baseline (first session) and after 4 to 6 weeks (second session) of EBUS TBNI	—

Secondary

Measure	Time frame
Overall Response Rate based on RECIST 1.1 criteria Timepoint: 13 weeks after the first dose of EBUS TBNI;Safety EvaluationTimepoint: 24 hours post admission or discharge (whichever is later)	—

Countries

India

Contacts

Public ContactPawan Tiwari

AIIMS New Delhi

pavan14281@gmail.com01126593676

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026