NCT04085250

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

A Phase II, Randomised Study of Nivolumab as Consolidation Therapy in Patients With Locally Advanced, Unresectable Non-Small Cell Lung Cancer (Stage III) Who Have Not Progressed Following Neoadjuvant Chemotherapy Plus Nivolumab and Definitive Concurrent Chemoradiation Therapy

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 264 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The phase II, randomised Study is to explore the efficacy and safety of nivolumab as consolidation therapy in patients with locally advanced, unresectable non-small cell lung cancer (stage III) who have not progressed following neoadjuvant chemotherapy plus nivolumab and definitive concurrent chemoradiation therapy

Conditions

• Stage III Non-small-cell Lung Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-11-28
• Primary completion: 2025-01-31
• Completion: 2025-01-31
• First posted: 2019-09-11
• Last updated: 2024-04-23

Locations

3 sites across 1 country: China