NCT03663166

Radiation and Chemotherapy With Ipilimumab Followed by Nivolumab for Patients With Stage III Unresectable Non-Small Cell Lung Cancer (NSCLC)

Radiation and Chemotherapy With Ipilimumab Followed by Nivolumab for Patients With Stage III Unresectable NSCLC

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is to determine if Stage III NSCLC patients treated with ipilimumab with thoracic radiation therapy followed by nivolumab monotherapy every 4 weeks for up to 12 months show an improved 12-month Progression Free Survival (PFS) rate compared with a 12-month historical PFS rate of 49% among patients treated in a similar fashion with concurrent chemoradiotherapy.

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
RADIATION	Thoracic Radiotherapy	2 Gy in 30 fractions directed at all sites of suspected disease
DRUG	Platinum Based Chemotherapy	Platinum based chemotherapy including cisplatin and etoposide, carboplatin and paclitaxel or cisplatin and pemetrexed (for patients with non-squamous histology).
DRUG	ipilimumab	ipilimumab 1mg/kg delivered concurrently with initiation of chemoradiotherapy and in week 4 of chemoradiotherapy
DRUG	Nivolumab	Nivolumab 480 mg (30 minute IV infusion) at least 7 days but no more than 21 days after completion of radiation and chemotherapy every 4 weeks for up to 12 cycles.

Timeline

• Start date: 2018-11-20
• Primary completion: 2021-10-22
• Completion: 2021-10-22
• First posted: 2018-09-10
• Last updated: 2023-02-15
• Results posted: 2023-02-15

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study