NCT02768558

Cisplatin and Etoposide Plus Radiation Followed By Nivolumab/Placebo For Locally Advanced NSCLC

Randomized, Double Blinded Phase III Trial of Cisplatin and Etoposide Plus Thoracic Radiation Therapy Followed By Nivolumab/Placebo For Locally Advanced Non-Small Cell Lung Cancer

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: RTOG Foundation, Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients with Stage III unresectable non-small cell lung cancer will receive thoracic radiation, cisplatin and etoposide followed by nivolumab or placebo given every 2 weeks for a year.

Detailed description

PRIMARY OBJECTIVES: I. To compare the Overall Survival (OS) for patients with Stage III unresectable non-small cell lung cancer treated with or without nivolumab following concurrent chemoradiation. II. To compare Progression-Free Survival (PFS) according to RECIST 1.1 criteria for patients with Stage III unresectable non-small cell lung cancer treated with or without nivolumab following concurrent chemoradiation.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
RADIATION	Radiation Therapy (RT)	2 Gy fractions once a day, 5 days per week, for a total of 60 Gy in 30 fractions.
DRUG	Cisplatin	Concurrently with radiation therapy, 50 mg/m2, IV, on days 1, 8, 29, and 36, to begin with day 1 of radiation therapy.
DRUG	Etoposide	Concurrently with radiation, 40 mg/m2, IV, on days 1-5 and 29-33, to begin with day 1 of radiation therapy.
DRUG	Nivolumab	Beginning 4-12 weeks after chemoradiation, 240 mg, IV, every 2 weeks for 16 weeks, then 480 mg, IV, for 36 weeks.
OTHER	Placebo	Beginning 4-12 weeks after chemoradiation, 240 mg, IV, every 2 weeks for 16 weeks, then 480 mg, IV, for 36 weeks.

Timeline

• Start date: 2016-10-17
• Primary completion: 2019-01-23
• Completion: 2019-01-23
• First posted: 2016-05-11
• Last updated: 2021-06-02
• Results posted: 2020-02-25

Locations

16 sites across 1 country: United States