Study of Nivolumab for Non-Small Cell Lung Cancer (Stage III) Following Neoadjuvant Chemotherapy Plus Nivolumab and Definitive Concurrent Chemoradiation Therapy

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

264

Participants

Timeline

Start Date

November 28, 2019

Primary Completion Date

January 31, 2025

Study Completion Date

January 31, 2025

Conditions
Stage III Non-small-cell Lung Cancer
Interventions
OTHER

Neoadjuvant therapy

The neoadjuvant therapy before radiotherapy comprised of Docetaxel 60 mg/m2 for 1 hour + Cisplatin 75 mg/m2+Nivolumab 360 mg, once every 3 weeks (Q3W), for a total of 2 cycles.

OTHER

Chemotherapy concurrent with radiotherapy

Docetaxel 25 mg/m2 for 1 hour +Cisplatin 25 mg/m2, once a week (QW)

RADIATION

Radiotherapy

Hypofractionated radiation technique was used to deliver a definitive radiation dose

DRUG

Nivolumab

Nivolumab consolidation (360 mg) via iv infusion once every 3 weeks (Q3W)±3 days after the neoadjuvant therapy and concurrent chemo-radiotherapy. Administration of nivolumab will commence on Day 1 following randomisation to Nivolumab after confirmation of eligibility and will continue on a Q3W schedule for a maximum duration of 12 months.

OTHER

Observation

Observation after the neoadjuvant therapy and concurrent chemo-radiotherapy.

Trial Locations (3)

510000

Sun yat-sen university cancer center, Guangzhou

The first affliated hospital of Guangzhou Medical University, Guangzhou

528000

The First People's Hospital of Foshan, Foshan

All Listed Sponsors
lead

Sun Yat-sen University

OTHER