Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Cisplatin

Nivolumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Patients in experimental group will receive Nivolumab consolidation (360 mg) via iv infusion Q3W±3 days after the neoadjuvant therapy and concurrent chemo-radiotherapy.

Patients in this group will receive observation after the neoadjuvant therapy and concurrent chemo-radiotherapy.

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.

Neoadjuvant therapy

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

Chemotherapy concurrent with radiotherapy

Hypofractionated radiation technique was used to deliver a definitive radiation dose

Radiotherapy

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.

Observation after the neoadjuvant therapy and concurrent chemo-radiotherapy.

Observation

Li Zhang, MD

Hui Liu, MD

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

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

To assess the efficacy of Nivolumab consolidation compared with observation in terms of progression-free survival

To assess the efficacy of Nivolumab consolidation compared with observation in terms of Overall survival

To assess the efficacy of Nivolumab consolidation compared with observation in terms of Objective Response Rate; To assess the efficacy of neoadjuvant chemotherapy plus nivolumab in terms of objective response rate after neoadjuvant therapy

To assess the safety of Nivolumab consolidation compared with observation in terms of adverse event

To assess the symptoms and health-related quality of life in patients treated with Nivolumab consolidation compared with observation

To assess the efficacy of neoadjuvant chemotherapy plus nivolumab in terms of progression-free survival for all patients

To assess the efficacy of neoadjuvant chemotherapy plus nivolumab in terms of overall survival for all patients

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Nivolumab for Non-Small Cell Lung Cancer (Stage III) Following Neoadjuvant Chemotherapy Plus Nivolumab and Definitive Concurrent Chemoradiation Therapy	NCT04085250	Stage III Non-s...	Neoadjuvant the... Chemotherapy co... Radiotherapy Nivolumab Observation	18 Years - 75 Years	Sun Yat-sen University
Study of Nivolumab for Non-Small Cell Lung Cancer (Stage III) Following Neoadjuvant Chemotherapy Plus Nivolumab and Definitive Concurrent Chemoradiation Therapy	NCT04085250	Stage III Non-s...	Neoadjuvant the... Chemotherapy co... Radiotherapy Nivolumab Observation	18 Years - 75 Years	Sun Yat-sen University
Study of Nivolumab for Non-Small Cell Lung Cancer (Stage III) Following Neoadjuvant Chemotherapy Plus Nivolumab and Definitive Concurrent Chemoradiation Therapy	NCT04085250	Stage III Non-s...	Neoadjuvant the... Chemotherapy co... Radiotherapy Nivolumab Observation	18 Years - 75 Years	Sun Yat-sen University

Spots Global Cancer Trial Database for nivolumab consolidation